NetCord-FACT Standards Scope and Content

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NetCord-FACT Standards Scope and Content Powered By Docstoc
					 Cord Blood Storage Options                                                                                                                                                          “Public” Cord Blood Banks Mission



                                                                                                                                                                                              • To collect, store and supply Cord Blood units with the
                                      1. Public Cord Blood Banking (Allogeneic/Unrelated)
                                                                                                                                                                                              highest quality and safety

                                      2. Medically Indicated, Directed Family Cord Blood                                                                                                      •   To improve the probability of finding suitable donors
                                         Storage
                                                                                                                                                                                              •   To promote the clinical use of Cord Blood
                                      3. Private Cord Blood Banking (Autologous or Family
                                         Storage)                                                                                                                                             • To promote research on biology and clinical application
                                                                                                                                                                                              of Cord Blood




Number of Cord Blood Units available for Unrelated
                                                                                                                                                                                                    NetCord-FACT Standards
                 Transplantation                                                                                                                                                                                                                          etCord
                                                                                                                                                                                                       Scope and Content

                                                                                                                                                                                   • Cover all phases of cord blood collection, processing, testing, banking,
                                                                                                                                                                                     selection, release
                                                             300                                                                                                    291
         Number of cord blood units




                                                                                                                                                          256
                                                             250                                                                               229

                                                                                                                                                                                   • Requirements
                                      (x thousand)




                                                             200                                                                  181

                                                             150                                                    136                                                               • Quality Management Program
                                                                                                      105                                                                             • Validated methods, supplies, reagents, equipment
                                                             100
                                                                                        70                                                                                            • Product tracking
                                                                         44
                                                             50
                                                                                                                                                                                      • Clinical outcome
                                                              0                                                                                                                       • Compliance with Applicable Law
                                                                       1999           2000          2001           2002          2003         2004     2005      2006


                                                                                                                                                                                   • Third Edition of Standards published in 2007
                                                                                                                        Year




                                                             UNRELATED CORD BLOOD BANK/REGISTRIES




                                          Number of stem cell products
                                      released for unrelated transplantation


                                              11,000
                                                                                                                                                                           2,075




                                              10,000
                                                                                                                                                                 1,791
     Number of donations




                                                     9,000
                                                                                                                                                       1,126




                                                     8,000
                                                                                                                                               963




                                                     7,000
                                                                                                                                  2,485 617




                                                                                                                                                                           5,416
                                                                                                                                                                  4,796
                                                                                                                     1,679 540




                                                     6,000
                                                                                                                                                        4,133
                                                                                                       1,127 390
                                                                                         653 368




                                                                                                                                               3,198




                                                     5,000
                                                                          282




                                                     4,000
                                                               155




                                                     3,000
                                                                              3,552


                                                                                           3,700


                                                                                                        3,515




                                                                                                                                    3,392


                                                                                                                                               3,187
                                                                                                                       3,238




                                                                                                                                                         3,133
                                                               3,082




                                                                                                                                                                   3,125


                                                                                                                                                                           3,002




                                                     2,000
                                                     1,000
                                                        0
                                                             1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
                                                                                                   Cord Blood Units Provided
                                                                                                   PBSC donations
                                                                                                   BM donations
      Number of Cord Bood Units provided for                                                                   Number of CBU per 10,000 Inhabitants
           Multi Cord Transplantation
                                                                                                        Country                       Number of inhabitants     Number of CBU     Number of units
                                                                                                        per                           (millions)                                  10,000 inhabitants

                                                                                                        1    Australia                19.7                      11,565            5.8
                                                                                                        2    Belgium                  10.2                      4,903             4.8
            Number of cord blood units




                                          600                                                           3    Finland                  5.2                       2,311             4.4
                                          500                                                           4    Spain                    40.2                      16,831            4.1
                                                                                                        5    Israel                   6.1                       2,043             3.3
                    provided




                                          400
                                                                                                        6    USA                      290.                      3 87,333          3.0
                                          300                                       600                 7    Italy                    58.0                      14,082            2.4
                                                                             432                        8    Singapore                4.4                       834               1.9
                                          200
                                                                                                        9    Netherlands              16.1                      2,889             1.7
                                          100               190                                         10   Germany                  82.3                      13,353            1.6
                                                  96
                                                                                                        11   Japan                    127.2                     19,889            1.5
                                           0
                                                2003      2004            2005     2006                 12   Czech Republic           10.0                      1,451             1.4
                                                                  Year                                  13   UK                       60.0                      5,889             0.9
           Remark: 2004: no information available of 29% of the units provided                          14   Switzerland              7.3                       686               0.9
                   2005: no information available of 45% of the units provided
                   2006: no information available of 41% of the units provided
                                                                                                        15   France                   63.0                      5,329             0.8
                                                                                                        16   Argentina                38.                       7 70              0.01
                                                                                                        17   Poland                   38.                       6 41              0.01

                                                                                                        Source: BMDW, ESSEC, January 2006
                                         UNRELATED CORD BLOOD BANKS/REGISTRIES




      Worldwide Storage of Cord Blood Units
                                                                                                                    The Institute of Medicine of the National
                                                                                                                            Academies – (USA) 2005

                                                        92,197

                                                                                                         • By increasing both the size and quality of the cord blood inventory,
147,311
                                                                                                           nearly 90 percent of all patients who need a transplant should be
                                                                                          32,745           able to find a suitable HLA match in either the marrow or the cord
                                                                                                           blood inventories.

                                                                                                         • Three fold increase in size of the global cord blood inventory
                                                                                               17,239
                                                1,481                                                    •      Stem Cell Therapeutic and Research Act (December 2005)
                                                                                                                150.000 additional donors, resulting in a target ratio of 8
                                                                                                                units per 10.000 inhabitants

                                         UNRELATED CORD BLOOD BANKS/REGISTRIES




                                                                                                                              Autologous Banking of Umbilical
          Future of Public Cord Blood Inventories                                                                                 Cord Blood Stem Cells

                                                                                                              Potential therapeutic application of cryopreserved Autologous
   • Improve the representation of ethnical minorities in public                                              Umbilical Cord Blood
   banks
                                                                                                                   • Autologous Stem Cell Transplantation

   • Further develop umbilical cord blood transplants for adults,                                                  • Regenerative medicine
   including partially compatible double-graft transplants                                                             • Treatment of Alzheimer’s disease
                                                                                                                       • Parkinson’s disease                                    A warehouse for stem cells
                                                                                                                       • Diabetes
   • Promote research on umbilical cord blood in regenerative
   medicine
                                                                                                                                                                The Cord Blood Cure



                                                                                                             Cord blood yields 'ethical' embryonic stem cells
                        Autologous Banking of Umbilical                                                                                                                                  Autologous Banking of Umbilical
                            Cord Blood Stem Cells                                                                                                                                            Cord Blood Stem Cells

1. Cord Blood Transplantation                                                                                                                                               • Unique opportunity for collection – Biological Insurance

        - Estimated use < 1:500 - 20.0000                                                                                                                                   • Cord Blood has unique properties and contains unique cell populations with
        - For hematological tumours allogeneic transplantation                                                                                                              therapeutic potential, i.e. Unrestricted Somatic Stem Cells (USSC) and
                                                                                                                                                                            Endothelial Progenitor Cells
          is often preferred
        - Few transplants performed                                                                                                                                         • The knowledge on Cord Blood biology evolves rapidly

                                                                                                                                                                            • Possibility for therapeutic application in the mid long-term
2. Regenerative Medicine                                                                                                                                                           Haplo-identical transplantation
                                                                                                                                                                                   Regenerative medicine
       - Degenerative diseases occur at relatively old age
       - Anticipated storage time 25-75 years                                                                                                                               • Cord Blood Cells can be stored long term
       - Preference over autologous bone marrow cells unsupported
       - No solid scientific basis                                                                                                                                          • Individuals have a right to store their own cells
       - Benefit unproven




                                                                                                                                                                              Private versus Public Banking of Cord Blood
 First Report of Autologous Cord Blood
 Transplantation in the Treatment of a Child With
 Leukemia                                                                                                                                                                   Public Cord Blood Banking                Private Cord Blood Banking
 Ammar Hayani, MD, Eberhard Lampeter, MD, David Viswanatha, MD, David Morgan,                                                                                               - Principle of Solidarity                - Competes with allogeneic application
 MD, Sharad N. Salvi, MD

 Sections of Pediatric Hematology/Oncology and Radiation Oncology, Advocate Hope Children’s Hospital and Christ Medical
                                                                                                                                                                            - Proven benefit                         - Unproven benefit
 Center, Oak Lawn, Illinois; VITA34 International AG, Leipzig, Germany; CorCell Inc, Philadelphia, Pennsylvania; Department of
 Pathology, Mayo Clinic, Rochester, Minnesota
                                                                                                                                                                            - Quality accreditation provider         - Quality accreditation candidate
 Financial Disclosure: Dr Lampeter works for CorCell Inc, a private cord blood– banking laboratory. The other authors have indicated they have no financial relationships       - Toward uniform standards                   - Standards diverse
                                                                                                                                                                                - Systematic outcome data                    - Outcome data not available
 relevant to this article to disclose.



 ABSTRACT                                                                                                                                                                       - Balanced information                       - Biased information
 We present the case of a 3-year-old girl with acute lymphoblastic leukemia who developed isolated central
 nervous system relapse while receiving chemotherapy 10 months after diagnosis. The child achieved a second                                                                 - Public money, non profit               - Private money, for profit
 remission on retreatment with systemic and intrathecal chemotherapy. She then underwent myeloablative
 chemotherapy and radiation therapy followed by infusion of her own umbilical cord blood, which the parents
 had saved after her delivery. She is now doing well and is in complete remission 20 months after cord blood                                                                - Continuity guaranteed                  - Continuity not guaranteed
 transplantation. In this first report of autologous cord blood transplantation for treatment of childhood
 leukemia, we discuss the safety and feasibility of this procedure as well as some of the uncertainties                                                                     - Equal access                           - Unequal access
 surrounding autologous cord blood collection and usage.

  Pediatrics 2007;119;296-300                                                                                                                                               - Global Inventory                       - No inventory




                                                                        etCord                                                                                                Can private and public banking be combined?

     The World Marrow Donor Association supports the establishment of public
     cord blood banks that are based on altruistic and voluntary cord blood                                                                                                     Royal Decree in Spain 2007
     donation.

                                                                                                                                                                                Autologous banking is allowed provided that:
      Today the likelihood that an autologous cord blood unit will be used for
      transplantation is very low. There is currently no clear proof that these cells
      will be able to be used for regenerative medicine or to treat other diseases in
                                                                                                                                                                                •    Unit must be made available for allogeneic transplantation if requested
      the future.

        National governments must ensure that the family receive impartial and                                                                                                  •    Uniform quality standards apply to all banks
        accurate information about the potential risks and benefits of private storage
        and sign an informed consent document.                                                                                                                                  •    Profit must be reinvested into the bank

        All cord blood banks should be subject to the same standards

        Promotion or general funding of autologous or related cord blood storage in the
        absence of a medical indication for directed donation should not be supported
        by national governments.
                       Acknowledgements

• Joan Garcia, Barcelona, Spain



• Paolo Rebulla, Milano, Italy



• Eliane Gluckman, Paris, France



• Machteld Oudshoorn, Leiden, The Netherlands



• Pablo Rubinstein, New York, USA

				
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