110308 20Exhibits 20for 205th 20Annual 20Report 20

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110308 20Exhibits 20for 205th 20Annual 20Report 20 Powered By Docstoc
					      CITR Annual Report Transplant
Collaborative IsletExhibits
       Registry (CITR)
     2008 Annual Report
            Exhibits
                        Prepared by:

                  CITR Coordinating Center
                  The EMMES Corporation
                       Rockville, MD

                         Sponsored by:
 National Institute of Diabetes & Digestive & Kidney Diseases
                  National Institutes of Health
            Juvenile Diabetes Research Foundation
                 Datafile Closure: April 1, 2008
                      Table of Contents
Chapter 1: Islet Transplant Activity
Chapter 2: Recipient and Donor Characteristics
Chapter 3: Pancreas Procurement, Islet Processing and Infusion
   Characteristics
Chapter 4: Immunosuppression and Other Medications
Chapter 5: Graft Function
Chapter 6: Liver, Kidney, Lipid and PRA Effects
Chapter 7: Adverse Events
Chapter 8: Registry Data Quality Review
CITR Coordinating Center
CITR Committees
Chapter 1: Islet Transplant Activity
   Islet Transplant Centers Reporting Data to CITR:
   Participating North American Centers 1999-2007




A - CITR Centers with at least one islet allograft infusion procedure conducted in 2007
C - CITR Centers with no islet allograft infusions in 2007
D - CITR Coordinating Center
     Number of Islet Transplantation Centers Performing Islet
               Allografts per Year and Number with
                  Data Entered in CITR Database
      All North American Islet Transplant Centers 1999-2007
                    25
                                                                                            23


                                                                            20
                    20                                                                            19


                                             16                                   16                         16
Number of Centers




                    15                                      14                                                    14


                                                  11              11
                                                                                                                       10
                    10               9
                                                                                                                            8
                          6              6
                     5
                               3


                     0
                         1999-2000   2001     2002            2003            2004            2005            2006      2007

                                             All North American Centers Performing Islet Allografts (N=31)
                                             CITR-Participating Centers with Data Entered (N=25)
Total Number of Islet Transplant Recipients, Recipients at
       CITR-Participating Centers, and Recipients
         with Detailed Data Reported to CITR By
           Year of First Islet Allograft Infusion
 All North American Islet Transplant Centers 1999-2007
                                 90
                                                                 82
                                 80
                                                                       75
                                                                             69
                                 70
                                                                                                                    64
          Number of Recipients




                                 60
                                                                                                   53                     55 53

                                 50
                                                   45 44                          45                     44
                                                                                                               41
                                 40
                                                                                        38                                        37
                                                            35                                36
                                      31 31                                                                                             32
                                                                                                                                              30
                                 30
                                                                                                                                                   21 20
                                 20           16                                                                                                            16

                                 10


                                  0
                                      1999-2000      2001             2002             2003             2004             2005          2006          2007

                                                                      All North American Recipients (N=378)
                                                                      All North American CITR Recipients (N=339)
                                                                      Recipients with Detailed Data Reported to CITR (N=296)


The Islet Transplant Summary (ITS) questionnaire is completed by all North American Islet Transplant
Programs regardless of their participation in the Registry. Of 46 North American islet transplant programs
polled, all have provided this information through 2007.
   Total Number of Islet Allograft Infusion Procedures
   Performed and Number with Data Reported to CITR:
CITR-Participating North American Islet Transplant Centers
                        1999-2007
                       160

                                                        142
                       140                                    132
                                                                                                          124
                                                                    119
                       120
                                                                                          110                   109 106
                                                                          106
Number of Procedures




                       100                                                                      93
                                                                                91
                                                                                     85              87
                                                                                                                          78
                        80
                                          65 64                                                                                 64 62
                        60
                             50 50                 49
                                                                                                                                        42
                        40           32                                                                                                       34
                                                                                                                                                    30

                        20


                         0
                             1999-2000      2001          2002              2003            2004            2005               2006          2007

                                                          All Infusions for North American Recipients (N=717)
                                                          All Infusions for North American CITR Recipients (N=637)
                                                          Infusions with Data Reported to CITR (N=570)
 Total Number (N=649) of Islet Allograft Infusion Procedures
         Conducted and Entered in CITR Database,
          by Year and Infusion Procedure Number:
CITR-Participating North American and International Centers,
                         1999-2007
                             135
                                                                                      125
                                                      119
                             120

                             105                                        100
                                                              96
 Number of Islet Infusions




                              90
                                                                                              79
                              75

                              60
                                                49
                              45      39                                                             38

                              30


                              15
                                                                                                            4
                               0
                                   1999-2000   2001   2002   2003      2004           2005   2006   2007   2008

                                                                    First infusion
                                                                    Second Infusion
                                                                    Third Infusion
                                                                    Fourth Infusion
           Total Number (N=649) of Islet Allograft
             Infusion Procedures Per Recipient:
CITR-Participating North American and International Centers,
                         1999-2007
                                        180
                                                          164
                                        160


                                        140
                 Number of Recipients

                                        120


                                        100
                                              84
                                         80                              71

                                         60


                                         40


                                         20
                                                                                        6
                                          0
                                              1             2             3             4

                                                   Total Number of Infusions Received

                                                     Islet Alone Recipients
                                                     Islet After Kidney Recipients
Total Number (N=712) of Deceased Donors per Islet Allograft
                    Infusion Procedure:
CITR-Participating North American and International Centers,
                         1999-2007
                                                       600   589

                                                       550

                                                       500
                 Number of Islet Allograft Infusions
                                                       450

                                                       400

                                                       350

                                                       300

                                                       250

                                                       200

                                                       150

                                                       100
                                                                           57
                                                        50
                                                                                         3
                                                         0
                                                              1            2             3

                                                             Total Number of Donors Received
       Islet Alone and Islet After Kidney Recipients:
CITR-Participating North American and International Centers,
                         1999-2007
Chapter 2: Recipient and Donor
       Characteristics
Recipient Demographics
Transplant Recipient Primary Funding Information
         CITR-Participating US Centers
Recipient Characteristics at First Infusion
Recipient Diabetes Characteristics at First Infusion
Recipient Diabetes Characteristics at First Infusion (continued)
Recipient Infectious Disease Testing at First Infusion
Recipient Characteristics at First Infusion by
    Total Number of Infusions Received
Recipient Demographics and Characteristics at First Infusion
           by Total Number of Infusions Received
Recipient Laboratory Values at First Infusion
Donor Demographics
All Allograft Donors
Donor Characteristics
 All Allograft Donors
Donor Characteristics
 All Allograft Donors
Characteristics of Organ Procurement and
          Donor Cause of Death
           All Allograft Donors
Treatments Given to Donor During Hospitalization
              All Allograft Donors
Treatments Given to Donor During Hospitalization
        All Allograft Donors (continued)
  Donor Serology
All Allograft Donors
Donor Laboratory Data
 All Allograft Donors
Organ Crossmatch Results
   All Allograft Donors
Chapter 3: Pancreas Procurement, Islet
processing and Infusion Characteristics
Pancreas Procurement and Islet Processing
Pancreas Procurement and Islet Processing (continued)
Pancreas Procurement and Islet Processing (continued)
Cold Ischemia Information
Islet Equivalents and Timing of Count
Islet Product Characterization
Differences in Islet Characteristics by Pancreas
              Preservation Method
               Univariate Analysis
Significant Relationships between Islet Outcomes and
                Categorical Predictors
                  Univariate Analysis
Univariate Correlation of Islet Characteristics with Donor,
       Recovery, and Processing Characteristics
Univariate Correlation of Islet Characteristics with Donor,
 Recovery, and Processing Characteristics (continued)
Univariate Correlation of Islet Characteristics with Donor,
 Recovery, and Processing Characteristics (continued)
Univariate Correlation of Islet Characteristics with Donor,
 Recovery, and Processing Characteristics (continued)
Islet Product and Infusion Characteristics by
             Infusion Sequence
Pre Infusion Portal Pressure by Infusion Sequence
Peak Portal Pressure by Infusion Sequence
Closure Portal Pressure by Infusion Sequence
Change from Pre Infusion to Closure Portal Pressure by
                 Infusion Sequence
Change from Pre Infusion to Peak Portal Pressure by
               Infusion Sequence
Cell Volume Infused per Infusion by Infusion Year
IEQs Infused per Infusion by Infusion Year
Chapter 4: Immunosuppression and other
              Medications
Immunosuppression Regimen at Time of First Infusion
Immunosuppression Regimen at Time of First Infusion
                   (continued)
 Antibodies Used Peri First Infusion for
          Induction Therapy
                                                         Allograft Type
                                                                  Islet After
                                                    Islet Alone     Kidney
                                                    N      %      N       %
Total                                               26            4
                                                     3    100.0   3       100.0

Daclizumab Alone                                    16            3
                                                     3     62.0   4        79.1

Daclizumab + Anti-Thymocyte Globulin                 5      1.9   -         0.0

Daclizumab + Anti-Thymocyte Globulin + Etanercept    8      3.0   -         0.0

Daclizumab + Infliximab                             18      6.8   2         4.7

Daclizumab + Etanercept                              9      3.4   3         7.0

Daclizumab + Efalizumab                              1      0.4   -         0.0

Alemtuzumab Alone                                   14      5.3   -         0.0

Alemtuzumab + Etanercept                             5      1.9   -         0.0

Alemtuzumab + Infliximab                             1      0.4   -         0.0

Anti-Thymocyte Globulin Alone                        5      1.9   1         2.3

Anti-Thymocyte Globulin + Etanercept                 9      3.4   2         4.7

Anti-Thymocyte Globulin + Efalizumab                 5      1.9   -         0.0

Basiliximab Alone                                    1      0.4   0         0.0

Basiliximab + Etanercept                            11      4.2   1         2.3

hOKT3γ-1(Ala-Ala) Alone                              8      3.0   -         0.0
Antibody Dosing at Time of Infusion by
         Infusion Sequence
Immunosuppression Dosing (mg/day) at Time of
       Infusion by Infusion Sequence
Immunosuppression Therapy Use at Specific Times Post
Last Infusion Allograft Recipients without Reported Graft
             Failure at the Time of Follow-Up
Immunosuppression Therapy Use at Specific Times Post Last
 Infusion Allograft Recipients without Reported Graft Failure
             at the Time of Follow-Up (continued)
Immunosuppression Dosing Post Last Infusion
Immunosuppression Dosing Post Last Infusion (continued)
Sirolimus Trough Level (ng/mL) Post Last Infusion
             All Allograft Recipients
Tacrolimus Trough Level (ng/mL) Post Last Infusion
             All Allograft Recipients
Anti-Hypertensive Medications Pre Infusion and
               Post Last Infusion
            All Allograft Recipients
Total Number of Anti-Hypertensive Medications
      Pre Infusion and Post Last Infusion
            All Allograft Recipients
Lipid Lowering Medications Pre Infusion and
             Post Last Infusion
          All Allograft Recipients
Total Number of Lipid Lowering Medications
    Pre Infusion and Post Last Infusion
          All Allograft Recipients
Adjunctive Therapy Used at Time of First Infusion
             All Allograft Recipients
              Adjunctive Therapy Post Last Infusion
                     All Allograft Recipients
                                                         Follow Up Visit

                               Month 6               Year 1                  Year 2              Year 3


                                     % of                 % of                  % of                % of
                           N        known        N       known       N         known        N      known
Total
                            246          100.0   217      100.0      150         100.0      92            100.0

Pentoxifylline                 31         12.6       1         0.5       -            0.0    -              0.0

Metformin                      11          4.5       7         3.2     6              4.0    4              4.3

Exenatide                       7          2.8       8         3.7     4              2.7    5              5.4

Rosiglitazone                   4          1.6       5         2.3     3              2.0    3              3.3

Pioglitazone                    2          0.8       1         0.5     1              0.7    -              0.0

Acarbose                        3          1.2       2         0.9     1              0.7    -              0.0

Repaglinide                     3          1.2       1         0.5     3              2.0    4              4.3

Sitagliptin                     1          0.4       1         0.5       -            0.0    -              0.0

Gliclazide                      -          0.0       -         0.0       -            0.0    1              1.1

Chromium picolinate             2          0.8       1         0.5     1              0.7    -              0.0

Iron                            5          2.0       7         3.2     6              4.0    -              0.0

Vitamins                       44         17.9    35          16.1     9              6.0    -              0.0
Chapter 5: Graft Function
Insulin Independence, Insulin Dependence, Absence of
           Fasting C-peptide, or Re-Infusion
                  Post First Infusion
                A. Islet Alone Recipients
                         80


                         70


                         60
 Percent of Recipients




                         50


                         40


                         30


                         20


                         10


                          0
                                        Day 30                     Day 75          Month 6                 Year 1                 Year 3*
                                        N=279                      N=279           N=275                   N=269                  N=198

                                      Recipient Status                      Re-Infused Prior to Follow-Up
                                                                            Insulin Independent
                                                                            Insulin Dependent with Detectable Fasting C-peptide
                                                                            No Detectable Fasting C-peptide or Known Graft Loss
                                                                            Missing Data


                              *Year 3 status regardless of re-infusion
Insulin Independence, Insulin Dependence, Absence of
           Fasting C-peptide, or Re-Infusion
                   Post First Infusion
             B. Islet After Kidney Recipients
                         80


                         70


                         60
 Percent of Recipients




                         50


                         40


                         30


                         20


                         10


                          0
                                        Day 30                      Day 75          Month 6                 Year 1                 Year 3*
                                        N=46                        N=46             N=45                   N=43                    N=36

                                       Recipient Status                      Re-Infused Prior to Follow-Up
                                                                             Insulin Independent
                                                                             Insulin Dependent with Detectable Fasting C-peptide
                                                                             No Detectable Fasting C-peptide or Known Graft Loss
                                                                             Missing Data


                              *Year 3 status regardless of re-infusion
                             Insulin Independence, Insulin Dependence or
                                      Absence of Fasting C-peptide
                                            Post Last Infusion
                                         A. Islet Alone Recipients
                        60



                        50
Percent of Recipients




                        40



                        30



                        20



                        10



                         0
                                   Month 6       Year 1                        Year 2                      Year 3
                                   N=269         N=260                         N=220                       N=160

                              Recipient Status            Insulin Independent
                                                          Insulin Dependent with Detectable Fasting C-peptide
                                                          No Detectable Fasting C-peptide or Known Graft Loss
                                                          Missing Data
                             Insulin Independence, Insulin Dependence or
                                      Absence of Fasting C-peptide
                                             Post Last Infusion
                                      B. Islet After Kidney Recipients
                        60



                        50
Percent of Recipients




                        40



                        30



                        20



                        10



                         0
                                   Month 6       Year 1                        Year 2                      Year 3
                                    N=44         N=40                          N=35                        N=31

                              Recipient Status            Insulin Independent
                                                          Insulin Dependent with Detectable Fasting C-peptide
                                                          No Detectable Fasting C-peptide or Known Graft Loss
                                                          Missing Data
      Insulin Independence, Insulin Dependence, or
               Absence of Fasting C-peptide
Post Last Infusion by Total Number of Infusions Received
                  Islet Alone Recipients
                 A. Recipients of 1 Infusion
                        60



                        50
Percent of Recipients




                        40



                        30



                        20



                        10



                         0
                                  Month 6       Year 1                        Year 2                      Year 3
                                   N=74         N=69                          N=57                        N=39

                             Recipient Status            Insulin Independent
                                                         Insulin Dependent with Detectable Fasting C-peptide
                                                         No Detectable Fasting C-peptide or Known Graft Loss
                                                         Missing Data
      Insulin Independence, Insulin Dependence, or
               Absence of Fasting C-peptide
Post Last Infusion by Total Number of Infusions Received
                   Islet Alone Recipients
                 B. Recipients of 2 Infusions
                         60



                         50
 Percent of Recipients




                         40



                         30



                         20



                         10



                          0
                                   Month 6       Year 1                        Year 2                      Year 3
                                   N=131         N=129                         N=112                       N=82

                              Recipient Status            Insulin Independent
                                                          Insulin Dependent with Detectable Fasting C-peptide
                                                          No Detectable Fasting C-peptide or Known Graft Loss
                                                          Missing Data
      Insulin Independence, Insulin Dependence, or
               Absence of Fasting C-peptide
Post Last Infusion by Total Number of Infusions Received
                   Islet Alone Recipients
                 C. Recipients of 3 Infusions
                        60



                        50
Percent of Recipients




                        40



                        30



                        20



                        10



                         0
                                  Month 6       Year 1                        Year 2                      Year 3
                                   N=64         N=62                          N=51                        N=39

                             Recipient Status            Insulin Independent
                                                         Insulin Dependent with Detectable Fasting C-peptide
                                                         No Detectable Fasting C-peptide or Known Graft Loss
                                                         Missing Data
Prevalence of Insulin Independence Post Last Infusion
                Islet Alone Recipients
                                      70




                                      60




                                      50
        Percent Insulin Independent




                                      40




                                      30




                                      20




                                      10




                                       0

                                           0     3       6     9    12       15     18        21      24         27    30      33        36

                                                                         Months Post Last Inf usion

                                                        Best Case                  Reported                       Worst Case



                                                     Month     0         6        12          18           24         30            36

                                               N Expected    279     269          260         245          220        194       160
Prevalence of Insulin Independence Post Last Infusion
       By Total Number of Infusions Received
                Islet Alone Recipients
                                  70




                                  60




                                  50
    Percent Insulin Independent




                                  40




                                  30




                                  20




                                  10




                                   0

                                       0   3   6       9           12         15       18     21        24        27     30   33     36

                                                                        Months Post Last Inf usion

  T otal Num ber of Infusi ons Recei ved                                               One                        T wo             T hree


                                                   Month                 0         6   12    18    24        30    36

                                                   N 1 Infusion          77    56      52    47    44        35    33

                                                   N 2 Infusions        125    121     111   95    91        71    58

                                                   N 3 Infusions         58    55      51    47    39        32    26
                             HbA1C
A. Post First Infusion (Censored at Re-Infusion before Visit)
                    Islet Alone Recipients

                           80


                           70


                           60
   Percent of Recipients




                           50


                           40


                           30


                           20


                           10


                            0
                                Pre Inf 1                     Month 6                             Year 1
                                N=279                         N=130                               N=94

                                            HbA1c < 6.5%
                                            6.5% <= HbA1c < 7.0%
                                            HbA1c >= 7.0%
                                            Missing data for recipient with islet graft failure
                                            Other missing data
                              HbA1C
A. Post First Infusion (Censored at Re-Infusion before Visit)
                 Islet After Kidney Recipients
                           80


                           70


                           60
   Percent of Recipients




                           50


                           40


                           30


                           20


                           10


                            0
                                Pre Inf 1                     Month 6                             Year 1
                                 N=46                          N=14                                N=9

                                            HbA1c < 6.5%
                                            6.5% <= HbA1c < 7.0%
                                            HbA1c >= 7.0%
                                            Missing data for recipient with islet graft failure
                                            Other missing data
                                                  HbA1C
                                          B. Post Last Infusion
                                         Islet Alone Recipients
                        80


                        70


                        60
Percent of Recipients




                        50


                        40


                        30


                        20


                        10


                         0
                             Pre Inf 1      Month 6                 Year 1                   Year 2    Year 3
                             N=279          N=269                   N=260                    N=220     N=160

                                                 HbA1c < 6.5%
                                                 6.5% <= HbA1c < 7.0%
                                                 HbA1c >= 7.0%
                                                 Missing data for recipient with islet graft failure
                                                 Other missing data
                                                      HbA1C
                                             B. Post Last Infusion
                                         Islet After Kidney Recipients
                        80


                        70


                        60
Percent of Recipients




                        50


                        40


                        30


                        20


                        10


                         0
                             Pre Inf 1         Month 6                 Year 1                   Year 2    Year 3
                              N=46              N=44                   N=40                     N=35      N=31

                                                    HbA1c < 6.5%
                                                    6.5% <= HbA1c < 7.0%
                                                    HbA1c >= 7.0%
                                                    Missing data for recipient with islet graft failure
                                                    Other missing data
                    C-peptide  0.5 ng/mL
A. Post First Infusion (Censored at Re-Infusion before Visit)
                    Islet Alone Recipients
                              90


                              80


                              70
      Percent of Recipients




                              60


                              50


                              40


                              30


                              20


                              10


                               0
                                   Pre Inf 1                  Month 6                      Year 1
                                   N=279                      N=130                        N=94

                                               C-peptide < 0.5 ng/mL or Known Graft Loss
                                               C-peptide >= 0.5 ng/mL
                                               Missing data
                     C-peptide  0.5 ng/mL
A. Post First Infusion (Censored at Re-Infusion before Visit)
                 Islet After Kidney Recipients
                             90


                             80


                             70
     Percent of Recipients




                             60


                             50


                             40


                             30


                             20


                             10


                              0
                                  Pre Inf 1                  Month 6                      Year 1
                                   N=46                       N=14                         N=9

                                              C-peptide < 0.5 ng/mL or Known Graft Loss
                                              C-peptide >= 0.5 ng/mL
                                              Missing data
                                         C-peptide  0.5 ng/mL
                                          B. Post Last Infusion
                                         Islet Alone Recipients
                        90


                        80


                        70
Percent of Recipients




                        60


                        50


                        40


                        30


                        20


                        10


                         0
                             Pre Inf 1      Month 6         Year 1        Year 2        Year 3
                              N=279         N=269           N=260         N=220         N=160

                                            C-peptide < 0.5 ng/mL or Known Graft Loss
                                            C-peptide >= 0.5 ng/mL
                                            Missing data
                                     C-peptide  0.5 ng/mL
                                     B. Post Last Infusion
                                 Islet After Kidney Recipients
                        90


                        80


                        70
Percent of Recipients




                        60


                        50


                        40


                        30


                        20


                        10


                         0
                             Pre Inf 1   Month 6         Year 1         Year 2       Year 3
                              N=46        N=44           N=40           N=35         N=31

                                         C-peptide < 0.5 ng/mL or Known Graft Loss
                                         C-peptide >= 0.5 ng/mL
                                         Missing data
                    Severe Hypoglycemia
A. Post First Infusion (Censored at Re-Infusion before Visit)
                    Islet Alone Recipients
                         100

                          90

                          80

                          70
 Percent of Recipients




                          60

                          50

                          40

                          30

                          20

                          10

                           0
                               Pre Inf 1                      Month 6                            Year 1
                                N=279                         N=130                              N=94

                                           No severe hypoglycemic episodes
                                           Severe hypoglycemic episode
                                           Missing data for recipient with islet graft failure
                                           Other missing data
                     Severe Hypoglycemia
B. Post First Infusion (Censored at Re-Infusion before Visit)
                 Islet After Kidney Recipients
                         100

                          90

                          80

                          70
 Percent of Recipients




                          60

                          50

                          40

                          30

                          20

                          10

                           0
                               Pre Inf 1                      Month 6                            Year 1
                                N=46                           N=14                               N=9

                                           No severe hypoglycemic episodes
                                           Severe hypoglycemic episode
                                           Missing data for recipient with islet graft failure
                                           Other missing data
                                          Severe Hypoglycemia
                                           C. Post Last Infusion
                                          Islet Alone Recipients
                        100

                         90

                         80

                         70
Percent of Recipients




                         60

                         50

                         40

                         30

                         20

                         10

                          0
                              Pre Inf 1   Day 30           Month 6               Year 1                  Year 2   Year 3
                              N=279       N=279            N=269                 N=260                   N=220    N=160

                                                   No severe hypoglycemic episodes
                                                   Severe hypoglycemic episode
                                                   Missing data for recipient with islet graft failure
                                                   Other missing data
                                              Severe Hypoglycemia
                                              D. Post Last Infusion
                                          Islet After Kidney Recipients
                        100

                         90

                         80

                         70
Percent of Recipients




                         60

                         50

                         40

                         30

                         20

                         10

                          0
                              Pre Inf 1     Day 30           Month 6                Year 1                 Year 2   Year 3
                               N=46         N=46              N=44                  N=40                   N=35     N=31

                                                     No severe hypoglycemic episodes
                                                     Severe hypoglycemic episode
                                                     Missing data for recipient with islet graft failure
                                                     Other missing data
                 Severe Hypoglycemia
                  E. Post Last Infusion
Islet Alone Recipients with Detectable Fasting C-peptide

                             100

                              90

                              80

                              70
     Percent of Recipients




                              60

                              50

                              40

                              30

                              20

                              10

                               0
                                   Pre Inf 1   Day 30    Month 6       Year 1         Year 2   Year 3
                                    N=57       N=215     N=188         N=162          N=89     N=58

                                                        Severe hypoglycemic episode
                                                        Missing data
                      Severe Hypoglycemia
                     F1. Post Last Infusion
All Islet Alone Recipients with No Detectable Fasting C-peptide
                      or Known Graft Loss
                                    100

                                     90

                                     80

                                     70
            Percent of Recipients




                                     60

                                     50

                                     40

                                     30

                                     20

                                     10

                                      0
                                          Pre Inf 1   Day 30      Month 6       Year 1          Year 2   Year 3
                                          N=201       N=13         N=28         N=45            N=61     N=54

                                                               Severe hypoglycemic episode
                                                               Missing data
                                                               No severe hypoglycemic episode
                   Severe Hypoglycemia
                   F2. Post Last Infusion
Islet Alone Recipients with No Detectable Fasting C-peptide
or Known Graft Loss and Known Information on Occurrence
             of Severe Hypoglycemic Episodes
                                 100


                                  90


                                  80

                                  70
         Percent of Recipients




                                  60


                                  50


                                  40

                                  30

                                  20


                                  10

                                   0
                                       Pre Inf 1   Day 30      Month 6       Year 1          Year 2   Year 3
                                       N=199       N=12         N=22         N=22            N=21     N=10

                                                            Severe hypoglycemic episode
                                                            No severe hypoglycemic episode
                             Hypoglycemia Status Pre First Infusion and
                                         Post Last Infusion
                                      All Allograft Recipients

                        70


                        60


                        50
Percent of Recipients




                        40


                        30


                        20


                        10


                         0
                             Pre Inf 1   Month 6                  Year 1                    Year 2   Year 3
                             N=325       N=313                    N=300                     N=255    N=191

                                               No hypoglycemic episodes
                                               Having episodes and aware
                                               Partial awareness
                                               Hypoglycemia unawareness
                                               Missing data for recipient with islet graft failure
                                               Other missing data
Graft Loss or Dysfunction Post Last Infusion
          A. Islet Alone Recipients

                             100

                              90

                              80

                              70
     Percent of Recipients




                              60

                              50

                              40

                              30

                              20

                              10

                               0
                                   Day 30 Month 6 Year 1 Year 2 Year 3
                                   N=279 N=269 N=260 N=220 N=160

                                            Complete Graft Failure
                                            Missing Data
                                            Graft Function
Graft Loss or Dysfunction Post Last Infusion
       B. Islet After Kidney Recipients

                             100

                              90

                              80

                              70
     Percent of Recipients




                              60

                              50

                              40

                              30

                              20

                              10

                               0
                                   Day 30 Month 6 Year 1   Year 2    Year 3
                                   N=46    N=44   N=40     N=35      N=31

                                            Complete Graft Failure
                                            Missing Data
                                            Graft Function
                                        Persistence of Islet Graft Function (IA, IAK)
                                                    A. Reported Data
                                 1.00
Survival Distribution Function




                                 0.75




                                 0.50




                                 0.25




                                 0.00

                                         0           5               10                15          20           25             30            35           40

                                                                                                 months
                                        STRATA:                           typeoftran=IA                                    Censored typeoftran=IA
                                                                          typeoftran=IAK                                   Censored typeoftran=IAK


                                                      Timepoint                    0         6            12         18         24         30        36

                                                     N Islet Alone                279       211           169        137       102         74        61

                                                  N Islet After Kidney            46        29            23         18         15         13        9
         Persistence of Islet Graft Function (IA, IAK)
B. Participants with More than Two Years of Missing Follow-
   Up Imputed as Graft Failure at Three Months after Last
                          Follow-Up
                                   1.00
  Survival Distribution Function




                                   0.75




                                   0.50




                                   0.25




                                   0.00

                                           0         5               10              15            20           25            30         35        40

                                                                                                 months
                                          STRATA:                          typeoftran=IA                               Censored typeoftran=IA
                                                                           typeoftran=IAK                              Censored typeoftran=IAK

                                                    Timepoint                        0      6             12     18      24        30         36

                                                    N Islet Alone                    279    214           174    138     106       74         61

                                                    N Islet After Kidney             46     30            25     18      16        13         10
                                                Persistence of Islet Graft Function by
                                                Ever Achieving Insulin Independence
                                                        Islet Alone Recipients
                                                     Not Censored at Re-Infusion
                                 1.00
Survival Distribution Function




                                 0.75



                                 0.50



                                 0.25



                                 0.00

                                        0              5             10              15             20          25             30        35     40

                                                                                                  months
                                                STRATA:                              EVER=Achieved insulin independence
                                                                                     Censored EVER=Achieved insulin independence
                                                                                     EVER=Never achieved insulin independence
                                                                                     Censored EVER=Never achieved insulin independence
                                                            Timepoint                        0            6    12        18         24    30   36

                                            N Achieved Insulin Independence                 177          154   125       109        79    66   52

                                            N Did Not Achieve Insulin Independence          102          63    48        36         23    11   7
                                  Achievement of Insulin Independence
                                       A. All Allograft Recipients
                                           Post First Infusion
                                      (Not Censored at Re-Infusion)
                        100

                         90

                         80
Percent of Recipients




                         70

                         60

                         50

                         40

                         30

                         20

                         10

                          0

                              0           6                        12                    18                     24             30        36

                                                                              Months Post First Infusion

                                               Type of Allograft                                Islet Alone
                                                                                                Islet After Kidney

                                              Timepoint                  0          6          12          18        24   30        36

                                   N Islet Alone                        279        113         73          58        46   29        23

                                   N Islet After Kidney                 46         15          9           9         9    5         4
                                      Achievement of Insulin Independence
                                            B. Islet Alone Recipients
                                                Post First Infusion
                                            (Censored at Re-Infusion)
                        100

                         90

                         80

                         70
Percent of Recipients




                         60

                         50

                         40

                         30

                         20

                         10

                          0

                              0                 2         4                                6        8        10

                                                              Months Post First Infusion

                                  N       279       144           91                65         50       37
            Achievement of Insulin Independence
                   C. Islet Alone Recipients
                      Post Second Infusion
(Recipients Not Insulin Independent after First Infusion, Censored
                         at Third Infusion)
                           100


                            90


                            80


                            70
   Percent of Recipients




                            60


                            50


                            40


                            30


                            20


                            10


                             0

                                 0             2             4                 6            8        10

                                                        Months Post Second Inf usion


                                     N   201       75            57       49           44       39
            Achievement of Insulin Independence
                   D. Islet Alone Recipients
                      Post Third Infusion
   (Recipients Not Insulin Independent after Second Infusion,
                 Censored at Fourth Infusion)
                        100


                         90


                         80


                         70
Percent of Recipients




                         60


                         50


                         40


                         30


                         20


                         10


                          0

                              0            2            4                  6           8        10

                                                    Months Post Third Inf usion



                                  N   64       26           19        18          18       16
                                Persistence of Insulin Independence and
                                     Persistence of Graft Function
                        Islet Alone Recipients Achieving Insulin Independence
                                       Not Censored at Re-Infusion
                         100




                         75
Percent of Recipients




                         50



                         25




                         0




                                                         Months Post First Achieving Insulin Independence
                                                                Persistence of Graft Function
                                                               Persistence of Insulin Independence

                                                                                                             30
                                                            0          6          12         18         24        36
                                         Timepoint
                                 N Without Graft Loss      177        154        125        109         79   66   52

                                 N Insulin Independent     177        126        102         80         55   37   22
                                  Persistence of Insulin Independence
                              By Total Number of Infusions Given Prior to
                                 Achievement of Insulin Independence
                        Islet Alone Recipients Achieving Insulin Independence
                        100



                         75
Percent of Recipients




                        50




                         25



                              0




                                                   Months Post First Achieving Insulin Independence
                                                                            Infusions = 1
                                                                              Infusions = 2
                                                                            Infusions = 3


                                                                                                           30
                                                  0              6             12           18        24        36
                                  Timepoint

                                  N 1 Infusion    56            36             27           23        16   9    6

                                  N 2 Infusions   92            66             55           41        31   21   12

                                  N 3 Infusions   28            24             20           16        8    7    4
                         Composite Outcome (Hypoglycemia and HbA1C)
                                       Post Last Infusion
                                   A. Islet Alone Recipients
                        70


                        60


                        50
Percent of Recipients




                        40


                        30


                        20


                        10


                         0
                             Pre Infusion 1          Day 30            Month 6            Year 1            Year 2            Year 3
                                N=279                N=279             N=269              N=260             N=220             N=160

                                              No severe hypoglycemic episodes and HbA1c < 6.5%
                                              No severe hypoglycemic episodes and 6.5% <= HbA1c < 7.0%
                                              Severe hypoglycemic episode or HbA1c >= 7.0% with detectable fasting c-peptide
                                              Severe hypoglycemic episode or HbA1c >= 7.0% without detectable fasting c-peptide
                                              Missing data for recipient with islet graft failure
                                              Other missing data
                             Composite Outcome (Hypoglycemia and HbA1C)
                                          Post Last Infusion
                                   B. Islet After Kidney Recipients
                        70


                        60


                        50
Percent of Recipients




                        40


                        30


                        20


                        10


                         0
                                Pre Infusion 1          Day 30            Month 6            Year 1            Year 2            Year 3
                                    N=46                N=46               N=44              N=40              N=35              N=31

                                                 No severe hypoglycemic episodes and HbA1c < 6.5%
                                                 No severe hypoglycemic episodes and 6.5% <= HbA1c < 7.0%
                                                 Severe hypoglycemic episode or HbA1c >= 7.0% with detectable fasting c-peptide
                                                 Severe hypoglycemic episode or HbA1c >= 7.0% without detectable fasting c-peptide
                                                 Missing data for recipient with islet graft failure
                                                 Other missing data
                                          Average Daily Insulin (Units) Taken By
                                                  Recipients on Insulin
                                             Baseline and Post Last Infusion
                                                A. Islet Alone Recipients
                                    100




                                    80
Average Daily Insulin Use (Units)




                                    60




                                    40




                                    20




                                     0
                                                267           59         61        51       38


                                           Pre Infusion 1   Month 6    Year 1     Year 2   Year 3
                                                                      Follow-Up
                                            Average Daily Insulin (Units) Taken By
                                                     Recipients on Insulin
                                               Baseline and Post Last Infusion
                                               B. Islet After Kidney Recipients

                                    100.0




                                     80.0
Average Daily Insulin Use (Units)




                                     60.0




                                     40.0




                                     20.0




                                      0.0
                                                  43            11         13        14       13


                                             Pre Infusion 1   Month 6    Year 1     Year 2   Year 3
                                                                        Follow-Up
                                       Average Daily Insulin (Units/Kg) Taken By
                                                Recipients on Insulin
                                           Baseline and Post Last Infusion
                                               A. Islet Alone Recipients
                                       1.2



                                       1.0
Average Daily Insulin Use (Units/kg)




                                       0.8



                                       0.6



                                       0.4



                                       0.2



                                        0
                                                 262            55         53        41       32


                                             Pre Infusion 1   Month 6    Year 1     Year 2   Year 3
                                                                        Follow-Up
                                             Average Daily Insulin (Units/Kg) Taken By
                                                        Recipients on Insulin
                                                 Baseline and Post Last Infusion
                                                  B. Islet After Kidney Recipients
                                       1.2



                                       1.0
Average Daily Insulin Use (Units/kg)




                                       0.8



                                       0.6



                                       0.4



                                       0.2



                                        0
                                                    42            9          9         12       10


                                               Pre Infusion 1   Month 6    Year 1     Year 2   Year 3
                                                                          Follow-Up
                                    Percent of Baseline Insulin Used By
                                           Recipients on Insulin
                                       Follow-Up Post Last Infusion
                                         A. Islet Alone Recipients
                              150
Percent of Baseline Insulin




                              100




                               50




                                0
                                         57        59                   50       36


                                       Month 6   Year 1               Year 2   Year 3
                                                          Follow-Up
                                    Percent of Baseline Insulin Used By
                                            Recipients on Insulin
                                       Follow-Up Post Last Infusion
                                      B. Islet After Kidney Recipients
                              125




                              100
Percent of Baseline Insulin




                               75




                               50




                               25




                                0
                                         11        13                   14       12


                                       Month 6   Year 1               Year 2   Year 3
                                                          Follow-Up
Percent of Baseline Insulin at Follow-Up Post Last Infusion
     Islet Alone Recipients who Achieved then Lost
                  Insulin Independence
                                            150

                                            135

                                            120
              Percent of Baseline Insulin

                                            105

                                             90

                                             75

                                             60


                                             45

                                             30

                                             15

                                              0    14        30        35       30

                                                  Month 6   Year 1    Year 2   Year 3

                                                               Follow-Up
Percent of Baseline Insulin at Follow-Up Post Last Infusion
                  Islet Alone Recipients
          Never Achieving Insulin Independence
                                           150

                                           135

             Percent of Baseline Insulin   120


                                           105

                                            90

                                            75

                                            60


                                            45

                                            30

                                            15

                                             0    42        29        15        6

                                                 Month 6   Year 1    Year 2   Year 3

                                                              Follow-Up
           Primary Outcomes Post First Infusion
Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up
According to Pre-Infusion Recipient, Donor, Procurement,
                 and Islet Characteristics
                   Islet Alone Recipients
            Primary Outcomes Post First Infusion
Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up
According to Pre-Infusion Recipient, Donor, Procurement,
 and Islet Characteristics Islet Alone Recipients (continued)
            Primary Outcomes Post First Infusion
Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up
According to Pre-Infusion Recipient, Donor, Procurement,
 and Islet Characteristics Islet Alone Recipients (continued)
            Primary Outcomes Post First Infusion
Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up
According to Pre-Infusion Recipient, Donor, Procurement,
 and Islet Characteristics Islet Alone Recipients (continued)
            Primary Outcomes Post First Infusion
Up to Re-Infusion, Complete Islet Failure, or Last Follow-Up
According to Pre-Infusion Recipient, Donor, Procurement,
 and Islet Characteristics Islet Alone Recipients (continued)
Achievement of Insulin Independence Post First Infusion Forest Plot
 (Hazard Ratio ± 95% Confidence Interval) Of Factors Univariately
                         Significant < 0.10
Loss of Insulin Independence Post First Infusion Forest Plot
   (Hazard Ratio ± 95% Confidence Interval) Of Factors
                Univariately Significant < 0.10
Complete Islet Failure Post First Infusion Forest Plot (Hazard
  Ratio ± 95% Confidence Interval) Of Factors Univariately
                      Significant < 0.10
Reinfusion Post First Infusion Forest Plot
(Hazard Ratio ± 95% Confidence Interval)
Of Factors Univariately Significant < 0.10
  Primary Outcomes Post Last Infusion
According to Pre-Infusion Recipient, Donor,
  Procurement, and Islet Characteristics
     Primary Outcomes Post Last Infusion
   According to Pre-Infusion Recipient, Donor,
Procurement, and Islet Characteristics (continued)
     Primary Outcomes Post Last Infusion
   According to Pre-Infusion Recipient, Donor,
Procurement, and Islet Characteristics (continued)
     Primary Outcomes Post Last Infusion
   According to Pre-Infusion Recipient, Donor,
Procurement, and Islet Characteristics (continued)
     Primary Outcomes Post Last Infusion
   According to Pre-Infusion Recipient, Donor,
Procurement, and Islet Characteristics (continued)
     Primary Outcomes Post Last Infusion
   According to Pre-Infusion Recipient, Donor,
Procurement, and Islet Characteristics (continued)
     Primary Outcomes Post Last Infusion
   According to Pre-Infusion Recipient, Donor,
Procurement, and Islet Characteristics (continued)
Achievement of Insulin Independence Post Last Infusion
Forest Plot (Hazard Ratio ± 95% Confidence Interval) Of
        Factors Univariately Significant p < 0.10
Loss of Insulin Independence Post Last Infusion Forest Plot
   (Hazard Ratio ± 95% Confidence Interval) Of Factors
              Univariately Significant p < 0.10
Complete Islet Failure Post Last Infusion Forest Plot (Hazard
  Ratio ± 95% Confidence Interval) Of Factors Univariately
                     Significant p < 0.10
                     Fasting Plasma Glucose (mg/dL)
                    Pre Infusion and Post Last Infusion
                           A. Islet Alone Recipients                                                         B. Islet After Kidney Recipients


                                                                                             400
        400

                                                                                             350
        350

                                                                                             300
        300

                                                                                             250
        250




                                                                                     mg/dL
mg/dL




                                                                                             200
        200

                                                                                             150
        150

                                                                                             100
        100

                                                                                              50
         50

                                                                                               0      41         32          7         33        30       23       16
          0     256        183         58         220      187      116       73
                                                                                                   Pre Inf 1 Pre Inf 2   Pre Inf 3   Month 6   Year 1   Year 2   Year 3
              Pre Inf 1 Pre Inf 2   Pre Inf 3   Month 6   Year 1   Year 2   Year 3
                                                                                                                                 Follow-Up
                                            Follow-Up
                                                                                                           Values greater than 400 mg/dL are not displayed
                      Values greater than 400 mg/dL are not displayed                                                      (Two at pre-inf 1)
                                      (Five at pre-inf 1)
                                      HbA1C (%)
                         Pre Infusion and Post Last Infusion

                         A. Islet Alone Recipients                                          B. Islet After Kidney Recipients




    12.5                                                                          12.5




    10.0                                                                          10.0




                                                                              %
%




     7.5                                                                           7.5




     5.0                                                                           5.0




     2.5     258       167       57       210        179     115       73          2.5      42       29         8        30        27       21       14

           Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6   Year 1   Year 2   Year 3              Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6   Year 1   Year 2   Year 3

                                      Follow-Up                                                                     Follow-Up
                                        Basal Plasma C-Peptide (ng/mL)
                                       Pre Infusion and Post Last Infusion

                                      A. Islet Alone Recipients                                                            B. Islet After Kidney Recipients




        6
                                                                                               6


        5                                                                                      5



        4                                                                                      4
ng/mL




                                                                                       ng/mL
        3                                                                                      3



        2                                                                                      2



        1                                                                                      1



        0                                                                                      0
              258         167          52          210       203     144      110                     39          29           5          30        27          24      17

            Pre Inf 1   Pre Inf 2   Pre Inf 3    Month 6    Year 1   Year 2   Year 3               Pre Inf 1   Pre Inf 2   Pre Inf 3    Month 6    Year 1     Year 2   Year 3

                                                Follow-Up                                                                              Follow-Up
                       Values greater than 6 ng/ml are not displayed                                            Values greater than 6 ng/ml are not displayed
                                                                                                                               (One at year 2)
                    (One at pre-inf 2, three at month 6 and one at year 1)
    Fasting Plasma Glucose (mg/dL)
   Pre Infusion and Post Last Infusion
Islet Alone Recipients with One Infusion

         400


         350


         300


         250
 mg/dL




         200


         150


         100


          50


           0      76          53         42        22       16

               Pre Inf 1   Month 6     Year 1    Year 2   Year 3

                                     Follow-Up
                HbA1C (%)
   Pre-Infusion and Post Last Infusion
Islet Alone Recipients with One Infusion
      12.5




      10.0
  %




       7.5




       5.0




       2.5      73          51         39        23       16

             Pre Inf 1   Month 6     Year 1    Year 2   Year 3

                                   Follow-Up
     Basal Plasma C-Peptide (ng/mL)
   Pre Infusion and Post Last Infusion
Islet Alone Recipients with One Infusion
         6



         5



         4
 ng/mL




         3



         2



         1



         0
                74         51         50         37       31

             Pre Inf 1   Month 6     Year 1    Year 2   Year 3

                                   Follow-Up
     Fasting Plasma Glucose (mg/dL)
    Pre Infusion and Post Last Infusion
Islet Alone Recipients with Two Infusions
         400


         350


         300


         250
 mg/dL




         200


         150


         100


          50


           0     122          124         113          99         65       41

               Pre Inf 1    Pre Inf 2   Month 6      Year 1      Year 2   Year 3

                                           Follow-Up
                       Values greater than 400 mg/dL are not displayed
                                       (Two at pre-inf 1)
                 HbA1C (%)
    Pre Infusion and Post Last Infusion
Islet Alone Recipients with Two Infusions
       12.5




       10.0
   %




        7.5




        5.0




        2.5     126         115         107      96       64       41

              Pre Inf 1   Pre Inf 2   Month 6   Year 1   Year 2   Year 3

                                         Follow-Up
      Basal Plasma C-Peptide (ng/mL)
    Pre Infusion and Post Last Infusion
Islet Alone Recipients with Two Infusions
          6



          5



          4
  ng/mL




          3



          2



          1



          0
                126          113          107          104           78        56

              Pre Inf 1    Pre Inf 2    Month 6       Year 1       Year 2      Year 3

                                            Follow-Up
                         Values greater than 6 ng/mL are not displayed
                      (One at pre-inf 2, three at month 6 and one at year 1)
      Fasting Plasma Glucose (mg/dL)
    Pre Infusion and Post Last Infusion
Islet Alone Recipients with Three Infusions
          400


          350


          300


          250
  mg/dL




          200


          150


          100


           50


            0      54         55         55         51        45       29       16

                Pre Inf 1 Pre Inf 2   Pre Inf 3   Month 6   Year 1   Year 2   Year 3

                                              Follow-Up
                        Values greater than 400 mg/dL are not displayed
                                       (Three at pre-inf 1)
                 HbA1C (%)
    Pre Infusion and Post Last Infusion
Islet Alone Recipients with Three Infusions
       12.5




       10.0
   %




        7.5




        5.0




        2.5      55       48        53        49        43       28       16

              Pre Inf 1 Pre Inf 2 Pre Inf 3 Month 6   Year 1   Year 2   Year 3

                                         Follow-Up
      Basal Plasma C-Peptide (ng/mL)
    Pre Infusion and Post Last Infusion
Islet Alone Recipients with Three Infusions
           6



           5



           4
   ng/mL




           3



           2



           1



           0
                  54          50          49          48        46       28       22

               Pre Inf 1   Pre Inf 2   Pre Inf 3    Month 6    Year 1   Year 2   Year 3

                                                   Follow-Up
        Fasting Plasma Glucose (mg/dL) Post Last Infusion
        Recipients Who Ever Achieved Insulin Independence

                            A. Islet Alone Recipients                                                 B. Islet After Kidney Recipients


        400
                                                                                    400


        350
                                                                                    350


        300
                                                                                    300


        250
                                                                                    250
mg/dL




                                                                            mg/dL
        200                                                                         200


        150                                                                         150


        100                                                                         100


         50                                                                          50


          0     172          158          147            100        66                0      28             23           21              17     12

              Pre Inf 1    Month 6      Year 1          Year 2     Year 3                 Pre Inf 1      Month 6        Year 1       Year 2    Year 3

                                     Follow-Up                                                                      Follow-Up
                 Values greater than 400 mg/dl are not displayed                             Values greater than 400 mg/dl are not displayed
                                 (Four at pre-inf 1)                                                         (One at pre-inf 1)
          Fasting Plasma Glucose (mg/dL) Post Last Infusion
         Recipients Who Never Achieved Insulin Independence

                                  A. Islet Alone Recipients                                           B. Islet After Kidney Recipients



        400
                                                                                    400


        350
                                                                                    350


        300
                                                                                    300


        250
                                                                                    250
mg/dL




                                                                            mg/dL
        200                                                                         200


        150                                                                         150


        100                                                                         100


         50                                                                          50


          0      84          62             40           16          7                0      13           10           9            6            4

              Pre Inf 1    Month 6        Year 1       Year 2      Year 3                 Pre Inf 1    Month 6       Year 1       Year 2       Year 3

                                       Follow-Up                                                                 Follow-Up
                 Values greater than 400 mg/dl are not displayed                             Values greater than 400 mg/dl are not displayed
                                 (One at pre-inf 1)                                                          (One at pre-inf 1)
                HbA1C (%) Post Last Infusion
     Recipients Who Ever Achieved Insulin Independence

                        A. Islet Alone Recipients                                            B. Islet After Kidney Recipients



    12.5
                                                                          12.5




    10.0
                                                                          10.0
%




     7.5




                                                                      %
                                                                           7.5




     5.0
                                                                           5.0




     2.5     172         150         142             99       66           2.5      27         22           19           16      12

           Pre Inf 1   Month 6      Year 1          Year 2   Year 3              Pre Inf 1   Month 6      Year 1       Year 2   Year 3

                                 Follow-Up                                                             Follow-Up
            HbA1C (%) Post Last Infusion
Recipients Who Never Achieved Insulin Independence

                       A. Islet Alone Recipients                                            B. Islet After Kidney Recipients


    12.5                                                                 12.5




    10.0                                                                 10.0




                                                                     %
                                                                          7.5
%




     7.5




                                                                          5.0
     5.0




                                                                          2.5      15          8            8             5       2
     2.5      86          60           37           16        7
                                                                                Pre Inf 1   Month 6      Year 1        Year 2   Year 3
           Pre Inf 1   Month 6       Year 1        Year 2   Year 3
                                                                                                      Follow-Up
                                  Follow-Up
             Basal Plasma C-Peptide (ng/mL) Post Last Infusion
            Recipients Who Ever Achieved Insulin Independence

                               A. Islet Alone Recipients                                              B. Islet After Kidney Recipients



        6                                                                            6




        5                                                                            5



        4                                                                            4
ng/mL




                                                                             ng/mL
        3                                                                            3



        2                                                                            2



        1
                                                                                     1



        0
                175          150          147              96        76              0
                                                                                            28             22            19              17       12

              Pre Inf 1    Month 6       Year 1        Year 2       Year 3
                                                                                         Pre Inf 1      Month 6        Year 1        Year 2      Year 3
                                      Follow-Up
                                                                                                                   Follow-Up
                    Values greater than 6 ng/mL are not displayed
                                                                                                 Values greater than 6 ng/mL are not displayed
                                  (Two at month 6)
                                                                                                                 (One at year 2)
   Basal Plasma C-Peptide (ng/mL) Post Last Infusion
  Recipients Who Never Achieved Insulin Independence

                             A. Islet Alone Recipients                                               B. Islet After Kidney Recipients



        6                                                                            6




        5                                                                            5




        4                                                                            4
ng/mL




                                                                             ng/mL
        3
                                                                                     3



        2
                                                                                     2



        1
                                                                                     1


        0
               83             60            56            48         34
                                                                                     0
                                                                                            11               8             8              7       5
            Pre Inf 1      Month 6        Year 1         Year 2     Year 3

                                       Follow-Up                                         Pre Inf 1       Month 6        Year 1          Year 2   Year 3

                    Values greater than 6 ng/mL are not displayed                                                    Follow-Up
                         (One at month 6 and one at year 1)
                              Fasting Plasma Glucose (mg/dL)
                                 Pre and Post First Infusion
                               Insulin Independent Recipients

                          A. Islet Alone Recipients                                                    B. Islet After Kidney Recipients



        400                                                                         400




        300                                                                         300




                                                                            mg/dL
mg/dL




        200                                                                         200




        100                                                                         100




                                                                                      0
          0                                                                                  41           2             5            16          9
                 256              14           30       122         120

                                                                                          Pre Inf 1     Day 7        Day 30       Month 6      Year 1
              Pre Inf 1         Day 7        Day 30   Month 6      Year 1
                                                                                                                 Follow-Up
                                         Follow-Up
                                                                                             Values greater than 400 mg/dl are not displayed
                 Values greater than 400 mg/dl are not displayed
                                                                                                             (Two at pre-inf 1)
                                 (Five at pre-inf 1)
                              Fasting Plasma Glucose (mg/dL)
                                 Pre and Post First Infusion
                               Insulin Dependent Recipients

                          A. Islet Alone Recipients                                                         B. Islet After Kidney Recipients




                                                                                    400
        400




                                                                                    300
        300




                                                                            mg/dL
mg/dL




                                                                                    200
        200




                                                                                    100
        100




                                                                                      0
                                                                                             41           34           32          22           18
          0
                 256           242          232         113         85
                                                                                          Pre Inf 1     Day 7       Day 30      Month 6        Year 1
              Pre Inf 1       Day 7       Day 30      Month 6      Year 1
                                                                                                                 Follow-Up
                                       Follow-Up                                             Values greater than 400 mg/dl are not displayed
                 Values greater than 400 mg/dl are not displayed                                             (Two at pre-inf 1)
                                 (Five at pre-inf 1)
                                         HbA1C (%)
                                Pre and Post First Infusion
                              Insulin Independent Recipients

                       A. Islet Alone Recipients                                     B. Islet After Kidney Recipients


    12.5
                                                                  12.5




    10.0
                                                                  10.0
%




     7.5




                                                              %
                                                                   7.5




     5.0                                                           5.0




     2.5                                                           2.5
              258             24              116     114                   42               3               15            9

           Pre Inf 1       Day 30          Month 6   Year 1              Pre Inf 1       Day 30          Month 6        Year 1

                                Follow-Up                                                        Follow-Up
                                       HbA1C (%)
                               Pre and Post First Infusion
                             Insulin Dependent Recipients

                    A. Islet Alone Recipients                                         B. Islet After Kidney Recipients




    12.5
                                                                   12.5




    10.0
                                                                   10.0
%




     7.5




                                                               %
                                                                    7.5




     5.0                                                            5.0




     2.5                                                            2.5
              258              139              105     79                   42               15              17           16

           Pre Inf 1        Day 30          Month 6   Year 1              Pre Inf 1        Day 30          Month 6       Year 1

                                 Follow-Up                                                      Follow-Up
                                 Basal Plasma C-Peptide (ng/mL)
                                   Pre and Post First Infusion
                                 Insulin Independent Recipients

                         A. Islet Alone Recipients                                                     B. Islet After Kidney Recipients




        6                                                                          6




        5                                                                          5




        4                                                                          4
ng/mL




                                                                           ng/mL
        3                                                                          3




        2                                                                          2




        1                                                                          1




        0                                                                          0
              258           10           28           120          119                    39              1            4           16            9

            Pre Inf 1     Day 7        Day 30        Month 6      Year 1               Pre Inf 1       Day 7        Day 30       Month 6       Year 1

                                    Follow-Up                                                                    Follow-Up
                  Values greater than 6 ng/mL are not displayed                                Values greater than 6 ng/mL are not displayed
                                (Two at month 6)                                                               (One at year 2)
                               Basal Plasma C-Peptide (ng/mL)
                                  Pre and Post First Infusion
                                Insulin Dependent Recipients

                          A. Islet Alone Recipients                                                  B. Islet After Kidney Recipients



        6                                                                          6




        5                                                                          5




        4                                                                          4
ng/mL




                                                                           ng/mL
        3
                                                                                   3



        2
                                                                                   2



        1
                                                                                   1



        0
              258          219           222           106         95              0
                                                                                          39        30           32           19         18
            Pre Inf 1     Day 7        Day 30         Month 6     Year 1
                                                                                       Pre Inf 1   Day 7       Day 30       Month 6     Year 1
                                    Follow-Up
                                                                                                            Follow-Up
                  Values greater than 6 ng/mL are not displayed
                       (One at month 6 and one at year 1)
Recipients with Fasting Blood Glucose  126 mg/dL
       Post Last Infusion by Insulin Status
             A. Islet Alone Recipients

                        100

                         90

                         80

                         70
Percent of Recipients




                         60

                         50

                         40

                         30

                         20

                         10

                          0
                                    Pre Infusion 1    Month 6     Year 1      Year 2       Year 3
                                      N=0 :256       N=136 :83   N=109 :78   N=58 :58     N=29 :44

                              Insulin Status                 Independent                Dependent
Recipients with Fasting Blood Glucose  126 mg/dL
       Post Last Infusion by Insulin Status
          B. Islet After Kidney Recipients

                         100

                          90

                          80

                          70
 Percent of Recipients




                          60

                          50

                          40

                          30

                          20

                          10

                           0
                                     Pre Infusion 1   Month 6         Year 1    Year 2       Year 3
                                        N=0 :41       N=17 :16       N=12 :18   N=7 :16      N=2 :14

                               Insulin Status                    Independent              Dependent
Insulin Dependent Recipients with
   Basal C-Peptide  0.5 ng/mL
         Post Last Infusion
     A. Islet Alone Recipients

                         100


                          90


                          80


                          70
 Percent of Recipients




                          60


                          50


                          40


                          30


                          20


                          10


                           0
                               Pre Inf 1 Month 6 Year 1   Year 2   Year 3
                               N=258 N=80        N=96     N=97     N=83
Insulin Dependent Recipients with
   Basal C-Peptide  0.5 ng/mL
         Post Last Infusion
  B. Islet After Kidney Recipients

                        100


                         90


                         80


                         70
Percent of Recipients




                         60


                         50


                         40


                         30


                         20


                         10


                          0
                              Pre Inf 1 Month 6 Year 1   Year 2   Year 3
                               N=39      N=14   N=17     N=18     N=15
                                Recipients with HbA1C < 6.5%
                              Post Last Infusion by Insulin Status
                                   A. Islet Alone Recipients

                        100

                         90

                         80

                         70
Percent of Recipients




                         60

                         50

                         40

                         30

                         20

                         10

                          0
                                    Pre Infusion 1    Month 6     Year 1      Year 2       Year 3
                                      N=0 :258       N=131 :78   N=108 :71   N=57 :58     N=30 :43

                              Insulin Status                 Independent                Dependent
                                   Recipients with HbA1C < 6.5%
                                Post Last Infusion by Insulin Status
                                  B. Islet After Kidney Recipients

                        100

                         90

                         80

                         70
Percent of Recipients




                         60

                         50

                         40

                         30

                         20

                         10

                          0
                                    Pre Infusion 1   Month 6         Year 1    Year 2       Year 3
                                       N=0 :42       N=16 :14       N=11 :16   N=6 :15      N=2 :12

                              Insulin Status                    Independent              Dependent
Pre-Infusion Recipient Lab Summary by Infusion Sequence
                  Islet Alone Recipients
Pre-Infusion Recipient Lab Summary by Infusion Sequence
               Islet After Kidney Recipients
Metabolic Summary by Follow-Up Post Last Infusion
             Islet Alone Recipients
Metabolic Summary by Follow-Up Post Last Infusion
           Islet After Kidney Recipients
Metabolic Summary Post Last Infusion by Insulin Status
              Islet Alone Recipients
Metabolic Summary Post Last Infusion by Insulin Status
           Islet Alone Recipients (continued)
 Secondary Complications of Diabetes
Pre First Infusion and Post Last Infusion
         All Allograft Recipients
 Secondary Complications of Diabetes
Pre First Infusion and Post Last Infusion
   All Allograft Recipients (continued)
 Secondary Complications of Diabetes
Pre First Infusion and Post Last Infusion
   All Allograft Recipients (continued)
 Secondary Complications of Diabetes
Pre First Infusion and Post Last Infusion
   All Allograft Recipients (continued)
          Ocular Complications
Pre First Infusion and Post last Infusion
         All Allograft Recipients
          Ocular Complications
Pre First Infusion and Post last Infusion
  All Allograft Recipients (continued)
Chapter 6: Liver, Kidney, Lipid and PRA
                 Effects
                             Incidence of Abnormal Liver Function Tests
                              at Any Scheduled Time Post First Infusion
                                       All Allograft Recipients

                        50

                        40
Percent of Recipients




                        30

                        20

                        10

                        0
                                 ALT                         AST                Alkaline Phosphatase           Total Bilirubin
                                                                         >=3X ULN
                                                                         2-3X ULN
                                                                         1-2X ULN


                                Lab values analyzed in this Exhibit are taken prior to each subsequent infusion
                              and at Month 6, Year 1, Year 2, and Year 3 after the last infusion procedure occurs.
             ALT (IU/L) Pre Infusion and Post Last Infusion


                             A. Islet Alone Recipients                                               B. Islet After Kidney Recipients



       150                                                                   150



       125                                                                   125



       100                                                                   100
IU/L




                                                                      IU/L
        75                                                                    75



        50                                                                    50



        25                                                                    25



         0   269      183       61       212      173     107   68             0    43       33       6        33       29      22      14


              Pre     Pre      Pre     Month 6 Year 1 Year 2 Year 3                 Pre     Pre      Pre     Month 6 Year 1 Year 2 Year 3
             Inf 1   Inf 2    Inf 3                                                Inf 1   Inf 2    Inf 3
                                      Follow-Up                                                             Follow-Up
               Values greater than 150 IU/L are not displayed                        Values greater than 150 IU/L are not displayed
                             (One at pre-inf 2)                                                    (One at pre-inf 2)
             AST (IU/L) Pre Infusion and Post Last Infusion


                          A. Islet Alone Recipients                                                    B. Islet After Kidney Recipients


                                                                                 120
       120


                                                                                 100
       100



        80                                                                        80




                                                                          IU/L
IU/L




        60                                                                        60



        40                                                                        40



        20                                                                        20



         0     269      183       61       212        173   107      68            0    43       33         6       33        29          22   14


               Pre      Pre      Pre     Month 6 Year 1 Year 2 Year 3                   Pre     Pre       Pre     Month 6 Year 1 Year 2 Year 3
              Inf 1    Inf 2    Inf 3                                                  Inf 1   Inf 2     Inf 3
                                        Follow-Up                                                                Follow-Up
              Values greater than 120 IU/L are removed for display                       Values greater than 150 IU/L are not displayed
                                (One at pre-inf 2)                                                     (One at pre-inf 2)
                            Alkaline Phosphatase (IU/L)
                        Pre Infusion and Post Last Infusion

                       A. Islet Alone Recipients                                                                 B. Islet After Kidney Recipients


                                                                                 350
       350

                                                                                 300
       300

                                                                                 250
       250

                                                                                 200
       200




                                                                          IU/L
IU/L




                                                                                 150
       150


                                                                                 100
       100


        50                                                                        50


              264      179       59        207      176     107      69            0             41        33         6        32        29         22     14
         0

              Pre      Pre       Pre     Month 6 Year 1 Year 2 Year 3                            Pre      Pre        Pre     Month 6 Year 1 Year 2 Year 3
             Inf 1    Inf 2     Inf 3                                                           Inf 1    Inf 2      Inf 3

                                        Follow-Up                                                                           Follow-Up
             Values greater than 350 IU/L are removed for display                             Values greater than 350 IU/L are removed for display
             (Two at pre-inf 2, one at month 6, and one at year 1)                     (Three at pre-inf 1, four at pre-inf 2, two at year 1, and one at year 2)
                                Total Bilirubin (mg/dL)
                         Pre Infusion and Post Last Infusion


                         A. Islet Alone Recipients                                                B. Islet After Kidney Recipients




                                                                              3.5
        3.5



        3.0                                                                   3.0



        2.5                                                                   2.5



        2.0                                                                   2.0




                                                                      mg/dL
mg/dL




        1.5                                                                   1.5



        1.0                                                                   1.0


        0.5                                                                   0.5


        0.0   265     182       59       206      174   106    66
                                                                              0.0    42      33         7        30       29         22   13

               Pre     Pre     Pre     Month 6 Year 1 Year 2 Year 3
                                                                                     Pre     Pre       Pre     Month 6 Year 1 Year 2 Year 3
              Inf 1   Inf 2   Inf 3
                                                                                    Inf 1   Inf 2     Inf 3
                                      Follow-Up
                                                                                                              Follow-Up
                                 Incidence of Abnormal Lipid Tests
                             at Any Scheduled Time Post First Infusion
                                       All Allograft Recipients
                        50

                        40
Percent of Recipients




                        30

                        20

                        10

                        0
                                       Total Cholesterol                                         Triglycerides
                                                                        2-3X ULN
                                                                        1-2X ULN


                               Lab values analyzed in this Exhibit are taken prior to each subsequent infusion
                             and at Month 6, Year 1, Year 2, and Year 3 after the last infusion procedure occurs.
                                   Total Cholesterol (mg/dL)
                              Pre Infusion and Post Last Infusion

                              A. Islet Alone Recipients                                          B. Islet After Kidney Recipients




                                                                                 350
        350


                                                                                 300
        300



        250                                                                      250



        200                                                                      200




                                                                         mg/dL
mg/dL




        150                                                                      150



        100                                                                      100



         50                                                                       50


              263     158         55        197      179   111    70                    41      25       5        29       26       22   15
          0                                                                        0

               Pre     Pre        Pre     Month 6 Year 1 Year 2 Year 3                  Pre     Pre     Pre     Month 6 Year 1 Year 2 Year 3
              Inf 1   Inf 2      Inf 3                                                 Inf 1   Inf 2   Inf 3
                                         Follow-Up                                                             Follow-Up
                                         HDL (mg/dL)
                              Pre Infusion and Post Last Infusion

                              A. Islet Alone Recipients                                             B. Islet After Kidney Recipients


        150
                                                                              150



        125
                                                                              125



        100                                                                   100
mg/dL




                                                                      mg/dL
         75                                                                    75



         50                                                                    50



         25                                                                    25



          0   260     146      46        185      169     100   66                   36      15        2        18       19        15   12
                                                                                0

               Pre     Pre     Pre     Month 6 Year 1 Year 2 Year 3                  Pre     Pre      Pre     Month 6 Year 1 Year 2 Year 3
              Inf 1   Inf 2   Inf 3                                                 Inf 1   Inf 2    Inf 3
                                      Follow-Up                                                              Follow-Up
                                   LDL (mg/dL)
                        Pre Infusion and Post Last Infusion

                        A. Islet Alone Recipients                                              B. Islet After Kidney Recipients



        300
                                                                               300



        250
                                                                               250



        200                                                                    200
mg/dL




                                                                       mg/dL
        150                                                                    150



                                                                               100
        100


                                                                                50
         50


                                                                                 0    36      15       2        18       19       15   12

          0   260     146       45        184       168   101   66
                                                                                      Pre     Pre     Pre     Month 6 Year 1 Year 2 Year 3
                                                                                     Inf 1   Inf 2   Inf 3
               Pre     Pre      Pre     Month 6 Year 1 Year 2 Year 3
              Inf 1   Inf 2    Inf 3                                                                         Follow-Up
                                       Follow-Up
                                     Triglycerides (mg/dL)
                              Pre Infusion and Post Last Infusion


                              A. Islet Alone Recipients                                        B. Islet After Kidney Recipients


                                                                              450
        450

                                                                              400
        400

                                                                              350
        350

                                                                              300
        300

                                                                              250




                                                                      mg/dL
        250
mg/dL




                                                                              200
        200

                                                                              150
        150

                                                                              100
        100

                                                                               50
         50

                                                                                     41      25        5        29       26       22   15
              263     157       55       197      178     109   70              0
          0
                                                                                     Pre     Pre      Pre     Month 6 Year 1 Year 2 Year 3
               Pre     Pre     Pre     Month 6 Year 1 Year 2 Year 3
                                                                                    Inf 1   Inf 2    Inf 3
              Inf 1   Inf 2   Inf 3
                                                                                                             Follow-Up
                                      Follow-Up
                             Incidence of Increase in Serum Creatinine (mg/dL)
                                       Greater than 0.5 from Baseline
                                 at Any Scheduled Time Post First Infusion
                                           All Allograft Recipients


                        50
Percent of Recipients




                        40

                        30

                        20

                        10

                        0
                                             Islet Alone                                         Islet After Kidney


                                                            >1.0 mg/dL increase from baseline
                                                            0.5 - 1.0 mg/dL increase from baseline


                                 Lab values analyzed in this Exhibit are taken prior to each subsequent infusion
                               and at Month 6, Year 1, Year 2, and Year 3 after the last infusion procedure occurs.
                                   Serum Creatinine (mg/dL)
                              Pre Infusion and Post Last Infusion


                              A. Islet Alone Recipients                                               B. Islet After Kidney Recipients


                                                                                4.0
        4.0


        3.5                                                                     3.5


        3.0                                                                     3.0


        2.5                                                                     2.5




                                                                        mg/dL
mg/dL




        2.0                                                                     2.0


        1.5                                                                     1.5


        1.0                                                                     1.0


        0.5                                                                     0.5


        0.0   271     186        61        219      190   121    75
                                                                                0.0    44      32        8        32        30           22   16

               Pre     Pre       Pre     Month 6 Year 1 Year 2 Year 3
                                                                                       Pre     Pre      Pre     Month 6 Year 1 Year 2 Year 3
              Inf 1   Inf 2     Inf 3
                                                                                      Inf 1   Inf 2    Inf 3
                                        Follow-Up
                                                                                                               Follow-Up
                      Calculated Creatinine Clearance (mL/min/1.73m2)
                            Pre Infusion and Post Last Infusion

                                       A. Islet Alone Recipients                                                       B. Islet After Kidney Recipients


                250
                                                                                                 250




                200
                                                                                                 200
mL/min/1.73m2




                                                                                 mL/min/1.73m2
                150
                                                                                                 150




                100
                                                                                                 100




                 50
                                                                                                  50


                       222      96        26        119      118   44     22
                                                                                                        28       8        1        12       14        9   7
                  0
                                                                                                   0
                        Pre     Pre       Pre     Month 6 Year 1 Year 2 Year 3
                                                                                                        Pre     Pre      Pre     Month 6 Year 1 Year 2 Year 3
                       Inf 1   Inf 2     Inf 3
                                                                                                       Inf 1   Inf 2    Inf 3
                                                 Follow-Up
                                                                                                                                Follow-Up
                                                       GFR (mL/min/1.73m2)
                                                Pre Infusion and Post Last Infusion

                                                A. Islet Alone Recipients                                                                  B. Islet After Kidney Recipients


                                                                                                                   180
                 180



                 150                                                                                               150



                 120                                                                                               120




                                                                                                  ml/min/1.73 m2
ml/min/1.73 m2




                  90                                                                                                90



                  60                                                                                                60



                  30                                                                                                30



                   0                                                                                                 0
                             271       186          61         219      190      121       75                                   44       32           8         32        30       22       16

                          Pre Inf 1 Pre Inf 2    Pre Inf 3   Month 6   Year 1   Year 2   Year 3                             Pre Inf 1 Pre Inf 2   Pre Inf 3   Month 6   Year 1   Year 2   Year 3
                                                         Follow-Up                                                                                        Follow-Up
                       Values greater than 180 ml/min/1.73 m2 have been removed for display
                                                                                                                         Values greater than 180 ml/min/1.73 m2 have been removed for display
                Class I PRA (%)
     Pre Infusion and Post Last Infusion
            Islet Alone Recipients
    100

     90

     80

     70

     60

     50
%




     40

     30

     20

     10

      0     247        165         55         140      123       78       48

          Pre Inf 1 Pre Inf 2   Pre Inf 3   Month 6   Year 1   Year 2   Year 3

                                        Follow-Up
 Change in Class I PRA from Pre First Infusion
Pre Subsequent Infusion and Post Last Infusion
            Islet Alone Recipients
                                100




                                 75
   Change from Pre Infusion 1




                                 50




                                 25




                                  0




                                -25     154          52        135       117      75       42

                                      Pre Inf 2   Pre Inf 3   Month 6   Year 1   Year 2   Year 3

                                                                 Follow-Up
         Class I PRA Post Last Infusion
Islet Alone Recipients with Complete Graft Loss
           Class I PRA Post Last Infusion
Islet Alone Recipients without Complete Graft Loss
       100

        90

        80

        70

        60

        50
   %




        40

        30

        20

        10

         0    130       115               64    41

             Month 6   Year 1         Year 2   Year 3

                              Follow-Up
      Class I PRA Post Last Infusion
Non-Immunosupressed Islet Alone Recipients
    Class I PRA Post Last Infusion
Immunosupressed Islet Alone Recipients
Chapter 7: Adverse Events
Percent of Recipients with an Adverse Event (AE)
        or Serious Adverse Event (SAE)
           in Year 1 Post First Infusion

                                                       Islet Alone (N=279)                Islet After Kidney (N=46)




                                               Recipients with    Recipients with   Recipients with     Recipients with
                                                   an AE             an SAE             an AE              an SAE


                                                 N        %         N        %        N         %         N           %

 Any Event

                                                 179      64%       127      46%       24       52%         20        43%

 Related to either the infusion procedure or
 immunosuppression therapy


                                                 147      53%         95     34%       19       41%         15        33%

 Related to the infusion procedure

                                                  93      33%         66     24%       12       26%           9       20%

 Related to immunosuppression therapy

                                                  97      35%         47     17%          9     20%           8       17%
                     Total Number of Adverse Events and
                            Serious Adverse Events
                         in Year 1 Post First Infusion
                                                                    Islet Alone                         Islet After Kidney


                                                                                  Serious
                                                                                    Adverse                       Serious Adverse
                                                         Adverse Events              Events    Adverse Events            Events

                                                          N        %         N          %       N         %         N        %

Total
                                                          509     100.0      252       100.0     44      100.0        34     100.0

Related to the infusion procedure
                                                          146      28.7       95        37.7     16       36.4        10      29.4

Related to immunosuppression therapy

                                                          155      30.5       63        25.0     16       36.4        14      41.2

Related  to   both   the    infusion   procedure   and
     immunosuppression therapy
                                                           23       4.5           8      3.2        -      0.0          -      0.0

Related to neither the infusion        procedure   nor
     immunosuppression therapy


                                                          185      36.3       86        34.1     12       27.3        10      29.4
IA: Incidence of Post-Transplant Adverse Events Related to
                    Infusion Procedure
IAK: Incidence of Post-Transplant Adverse Events Related to
                    Infusion Procedure
IA: Incidence of Post-Transplant Adverse Events Related to
                    Immunosupression
  Therapy Follow-up based on completed scheduled visits
IAK: Incidence of Post-Transplant Adverse Events Related to
                    Immunosupression
  Therapy Follow-up based on completed scheduled visits
                         Percent of Recipients with a Serious Adverse Event
                        in Year 1 Post First Infusion by Year of First Infusion
                                       All Allograft Recipients
                        60


                        50
Percent of Recipients




                        40


                        30


                        20


                        10


                         0
                             1999   2000   2001        2002          2003          2004          2005          2006   Year of First Infusion
                             N=6    N=12   N=35        N=69          N=41          N=47          N=60          N=36

                                                  Any SAE
                                                  SAE related to either the infusion procedure or immunosupression
                                                  SAE related to the infusion procedure
                                                  SAE related to immunosupression
Serious Adverse Event Type by Relatedness to
     Islet Infusion or Immunosuppression
Outcome of Serious Adverse Events by Relatedness to
       Islet Infusion or Immunosuppression
Serious Adverse Events MedDRA System/Organ Class
by Relatedness to Islet Infusion or Immunosuppression
Serious Adverse Events MedDRA System/Organ Class
by Relatedness to Islet Infusion or Immunosuppression
                       (continued)
Most Common Serious Adverse Events
      MedDRA Preferred Term
       Islet Alone Recipients
Most Common Serious Adverse Events
        MedDRA Preferred Term
     Islet After Kidney Recipients
Most Common Serious Adverse Events Reported
       Within One Year of Any Infusion
           MedDRA Preferred Term
           All Allograft Recipients
Most Common Serious Adverse Events Reported
     More than One Year after Any Infusion
            MedDRA Preferred Term
            All Allograft Recipients
Summary of Reported Neoplasms
Summary of Reported Neoplasms (continued)
Listing of Reported Hemorrhages
  and Portal Vein Thromboses
      All Allograft Recipients
 Listing of Reported Hemorrhages
    and Portal Vein Thromboses
All Allograft Recipients (continued)
Listing of Reported Hemorrhages
   and Portal Vein Thromboses
All Allograft Recipients (continued)
Listing of Reported Hemorrhages
   and Portal Vein Thromboses
All Allograft Recipients (continued)
Number of Days Hospitalized at Infusion
   (from Admission to Discharge)
        by Infusion Sequence
        Islet Alone Recipients
                     20




                     15
    Number of Days




                     10




                      5




                      0
                          271          184          58

                           1            2           3
                                Infusion Sequence
Number of Days Hospitalized at Infusion
   (from Admission to Discharge)
         by Infusion Sequence
     Islet After Kidney Recipients
                    50




                    40
   Number of Days




                    30




                    20




                    10




                     0   43          33           8


                         1            2           3
                              Infusion Sequence
Hospitalization Experienced Post Last Infusion by
      Total Number of Infusions Received
              Islet Alone Recipients
Hospitalization Experienced Post Last Infusion by
      Total Number of Infusions Received
           Islet After Kidney Recipients
Chapter 8: Registry Data Quality Review
Expected and Submitted Forms by Infusion Sequence
             A) Islet Alone Recipients
Expected and Submitted Forms by Infusion Sequence
          B) Islet After Kidney Recipients
Expected and Submitted Follow-Up Forms
           Post Last infusion
        All Allograft Recipients
Extent of Follow-Up Post Last Infusion
        All Allograft Recipients
CITR Coordinating Center
  (July 2007 – July 2008)

  PI: Franca Benedicty Barton
    Co-PI: Donald Stablein
      Yamini Damodharan

         Ruth Danoff

        Jodi DeStefano

       Andrew Heitman

         Krista Huang

      Christina Mandzuk

         Steve Wease
               CITR Committees

Scientific Advisory Committee (SAC)


Compliance Committee (2008)


Data Elements Committee (2008)


Publications/Presentations Committee (2008)


Transplant Coordinators’/Data Managers’ Committee (2008)
CITR Scientific Advisory Committee (SAC)
           Chair: Bernhard J. Hering

                 Michael Appel

            Franca Benedicty Barton

                Michael Cecka

                Philip E. Cryer

                 Olle Korsgren

               Maureen McBride

                Jerry P. Palmer

                Camillo Ricordi

                 Gordon Weir
CITR Compliance Committee (2008)

         Chair: Fouad Kandeel

            Michael Appel

           Parastoo Dinyari

              Albert Hwa

             Carol Kramer

           Joan Martellotto

           Violetta Raverdi

             Marti Sears

             Elyse Stuart
CITR Data Elements Committee (2008)

            Chair: Marti Sears

               David Baidal

              Enrico Cagliero

              Marc Garfinkel

              Fouad Kandeel

              Dixon Kaufman

             Robert Ketchum

              Francois Pattou

             David Sutherland
CITR Publications/Presentations Committee (2008)

                Chair: Rodolfo Alejandro

                     Michael Appel

                     Nancy Bridges

                Shari Messinger Cayetano

                     Brian Flanagan

                   Elizabeth Holbrook

                    Robert Ketchum

                   Bashoo Naziruddin

                      Craig Smith
                CITR Transplant Coordinators’/
               Data Managers’ Committee (2008)
Chair: Parastoo Dinyari   Robin Jevne             Nancy Radke
Jarrett Anderson          Jenny Joseph            Violeta Raverdy
David Baidal              Debra Kemp              Marilyn Reeve
LeAnn Batterson           Mark Lockwood           Kristi Schneider
Meyer Belzer              Eileen Markmann         Marti Sears
Elsa Boely                Joan Martellotto        Jill Sheedy
Jane Fasbender            Marli McCulloch-Olson   KD Shiang
Courtney Garbee           Joan McElroy            Elyse Stuart
Susan George              Melissa McGraw          Pat Swanson
Debbie Grice              Suzanne Miller          Heather Turgeon
Darrell Grimes            Bashoo Naziruddin       Patricia Wilson
Jeannette Hacker          Lori Otken              Dona Winborne
Celia Hartigan            Maral Palanjian         Piotr Witkowski
Elizabeth Holbrook        Jamen Parkey

				
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