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Statistics of Autologous Cord Blood Storage and Use

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					        Statistics of Autologous
      Cord Blood Storage and Use


J.J. Nietfeld, Ph.D.
University Medical Center
Utrecht, The Netherlands


Frances Verter, Ph.D.
www.ParentsGuideCordBlood.com

OCT 2004          Nietfeld & Verter   1
                Contents

• Introduction to authors
• Review of cord blood industry
• Inventory of stored cord blood in USA
• Previous opinions and estimates re usage
• Calculate lifetime probability of
  autologous transplant
• Forecast lifetime probability of autologous
  use for regenerative medicine
• Implications

OCT 2004          Nietfeld & Verter         2
      J.J. Nietfeld, Ph.D., Biography
• Biochemist & Pathobiologist
• Associate Professor, UMC Utrecht, The Netherlands
• P.I. 2003 ZonMw report:
“Desirability and feasability of a Personal Cell Bank”


 Netherlands Report proposes 3-way split of stored
 cord blood:
                1- private portion
                2- public portion
                3- research portion


 OCT 2004              Nietfeld & Verter                 3
OCT 2004   Nietfeld & Verter   4
        ParentsGuideCordBlood.com
   • Mission Statement:
     Impartial review of cord blood storage options

How To use website          Public Bank List
Medical motives for storage Private Bank List
Diseases Treated by SCT     Types of banks
Research                         Regulations by nationality
News reports                     Lab processing
Ethical & Legal Issues           Suggested Questionnaire
Cost & Reimbursement             Summaries & Prices


   OCT 2004              Nietfeld & Verter                5
             Website Readership

                                   67,494 = 36.03 %   .net
                                   38,656 = 23.51 %   .com
                                   38,590 = 21.20 %    (numerical IP)
                                    3,837 = 2.85 %    .br (Brazil)
                                    4,338 = 2.81 %    .edu (USA Edu)
                                    1,930 = 1.24 %    .org (Non-Profits)
                                    2,140 = 1.19 %    .de (Germany)
                                    1,938 = 1.06 %    .ca (Canada)
                                    1,942 = 1.05 %    .au (Australia)
                                    2,468 = 1.03 %    .mx (Mexico)
                                   14,716 = 8.03 %     ALL OTHERS


– Hits from over 70 foreign countries in the past month
– Average monthly hits over past year: 158,933
  OCT 2004             Nietfeld & Verter                            6
        Types of Cord Blood Banks
            Private              Transplant    Research
            bank                 public bank   public bank
Parent cost $900-$1800           Free          Free

Blood       Parents              Bank          Bank
owner
Bank        Parents              Med. Ins.     Sales &
income                           & Sales       Patents
Blood       Parental             Transplants   Research
usage       discretion           & Research

OCT 2004              Nietfeld & Verter                   7
           USA Cord Blood Inventory

NUMBER                         9/2003           9/2004      +%
Private CB Banks                          15          21    40%
Public CB Banks                           18          20    11%
# private customers             179,350        > 270,991    55%
# public donations                 58,650      > 76,145     21%
NMDP + NYBC alone                  49,000        59,325
# private CBT's             55 to date         71 to date   29%


OCT 2004              Nietfeld & Verter                      8
           Investments in CB Banking

$ 8 M NMDP 2004 infusion to cord blood banking

$ 9 M National Cord Blood Program year 1 funding

$ 75 M CBR investment in new building over 5 years




OCT 2004             Nietfeld & Verter           9
    Previous Opinions Against
  Autologous Cord Blood Banking
• American College of Ob and Gyn (ACOG)
  1997; Int J Gyn Ob, 58(2):257-259
• American Academy of Pediatrics
   July 1999; Pediatrics, 104:116-118
• Royal College of Ob and Gyn
   Oct. 2001; Opinion Paper 2
• European Group on Ethics in Science and
  New Technologies
   March 2004; Opinion No.19

OCT 2004         Nietfeld & Verter      10
     Previously Published Chances
     for Autologous Transplant Use
• 74 : 200,000 (< 20 yrs)
  F.L. Johnson, 1997; J Ped Hem Onc 19(3): 183-186.
  (based on statistics of diseases and treatments)
• 1 : 20,000 ( < 20 yrs)
  G.J. Annas, 1999; NEJM 340: 1521-1524.
  (not substantiated)
• 1 : 10,000 – 1 : 200,000 (lifetime)
  R.M. Kline, April 2001; Sci Amer 4: 30-37.
  (not substantiated)

 OCT 2004              Nietfeld & Verter          11
  Lifetime storage of Cord Blood:
  source of autologous stem cells

• At – 196 °C it takes thousands of years for
  cosmic radiation to damage cells
• Cord Blood Transplants on adults have
  been successful in clinical trials
• Numerous companies are “expanding” cord
  blood cell counts
• Current research focus is speeding cord
  blood engraftment

OCT 2004          Nietfeld & Verter       12
     Probability of an autologous
   transplant during one’s lifetime

    The probability P depends on a formula which
   the authors wish to reserve until it is published.



P is a function of n and p
Where:
n = maximum age for treatment
p = probability / year of autologous transplant

OCT 2004               Nietfeld & Verter                13
       Data for North America 2002
Transplants (Ref: CIBMTR)                        Number
Autologous Blood & Marrow                            10,500
Allogeneic Blood & Marrow                              7,200

Population                                       Number
USA                                              288,000,000
Canada                                            31,000,000
                                         Total   319,000,000
      Population minus those over 70             290,000,000

OCT 2004             Nietfeld & Verter                    14
           Autologous Transplant
    Lifetime Odds: North America 2002

             Probability P = 0.25%
Using
n = maximum age for treatment = 70
p = probability / year of autologous transplant
  = (# autol. transplants per year) / (population < 70)
  = (10,500)/(290 million)




OCT 2004               Nietfeld & Verter              15
              Autologous Transplant Lifetime
                  Chances up to age 70
               0.3

              0.25

               0.2
Chance in %




              0.15                                                  Chance / life

               0.1

              0.05

                0

                      North        9 EU               Netherlands
                     America     countries
                               Geographic Area

OCT 2004                          Nietfeld & Verter                          16
           Forecast of cord blood use
            for regenerative medicine
• Given long “shelf life” of cord blood,
  today’s babies can use autologous cord
  blood for future regenerative medicine
• Auto CB carries advantages over Auto BM:
    – Stem cells have more “plasticity” (under study)
    – No surgical harvest
    – Lower cost (depending on storage time)
• Lifetime probability of diagnosis gives an
  UPPER LIMIT for treatment

OCT 2004              Nietfeld & Verter            17
    Example: autologous stem cells
     for Cellular Cardiomyoplasty
ie: stem cell
transplantation
for cardiac repair.

Indications:
Myocardial
Infarction,
Congestive
Heart Failure

 OCT 2004             Nietfeld & Verter   18
OCT 2004   Nietfeld & Verter   19
           Cellular Cardiomyoplasty
           Lifetime Odds: USA 2001

           Probability P = 14%

Example: USA inpatient PCI up to age n=75
Yearly rate p = (571,000/ 264,818,014) = 0.002
(Ref: American Heart Association Statistics)




OCT 2004            Nietfeld & Verter        20
                                          Diagnoses
                         Autologous Stem Cell
                            Probability per Lifetime
                         Transplantation   (average lifetime-
                         (max age = 70)                    expectancy = 78,5)
                Autologous transplant                 or       Diagnosis
                25

                20
Chance (in %)




                15

                10

                 5

                 0
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OCT 2004                                   Nietfeld & Verter                    21
                  Implications
• Autologous cord blood storage outnumbers
  public donations and is growing faster.
• USA National Cord Blood Program will invest less
  $$ towards growth than private companies.
• Correct probability of autologous stem cell use is
  much higher than standard assumptions.
• Regenerative medicine dramatically increases
  opportunities for autologous use of stem cells.
• Private cord blood banking is here to stay.


 OCT 2004             Nietfeld & Verter                22
Future: harness private inventory
        for public good?
• Need 150,000 CB for all USA transplants
   (Ref: Pablo Rubinstein, M.D., NYBC)
• Private banks will add that much to
  inventory in less than 2 years.
• Instead of the USA government funding
   a program of public banks ---
• Why not offer parents in private banks
           a REGISTRY OPTION?
           (with quality standards)

OCT 2004          Nietfeld & Verter         23

				
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