Cord Blood Establishing a National Hematopoietic Stem Cell Bank Program (2005) / Chapter Skim
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Executive Summary
Executive Summary
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, The National Cord Blood Program of the New York Blood Center (NYBC) , and the Cord Blood Banking and Transplantation (COBLT)
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The committee proposes the creation of a National Cord Blood Stem Cell Bank Program. The committee makes specific recom mendations for the organization and administration, data manage ment, and quality control in the national program that would best serve the needs of both the donors and the patients requiring stem cell transplants.
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However, despite the large numbers of adult donors recruited over the past two decades, registries and transplant physicians still face several challenges, including: · an inability to identify fully or closely matched HLA donors for a significant proportion of transplant candidates, particularly non-Caucasian individuals; · permanent or transient unavailability of some potential donors, even if that individual was identified in a registry on the basis of HLA match; · the prolonged interval between the time of a search request and the time of HPC acquisition (the currently reported median time is greater than 4 months) ; and · risks associated with bone marrow and peripheral blood donation.
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, the U.S. Congress provided $10 million for the establishment of a National Cord Blood Stem Cell Bank Program under the leadership of the
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to provide HRSA with an assessment of existing cord blood programs and inventories and to make recommendations on the ideal structure, function, and utility of a National Cord Blood Stem Cell Bank Program. The charge to the IOM committee is as follows: In response to Conference Report on H.R.
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? The IOM formed the Committee on Establishing a National Cord Blood Stem Cell Bank Program, which consists of experts in the fields of economics, HPC transplantation, outcomes analysis, biostatistics, stem cell biology, cord blood quality and standards, public health, health technology assessment, patient advocacy, ethics, and obstetrics and gynecology.
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Centers performing cord blood transplants should also be accredited to ensure the proper selection and thawing of cord blood units. FDA licensure of cord blood units is another means by which uniformity and high standards can be met.
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The Health Resources and Services Administration should iden tify a Cord Blood Accrediting Organization by means of an open, competitive request for proposal process. This organization should be charged with the delineation of standards for any cord blood bank, collection center, or transplant center desiring to participate in the National Cord Blood Stem Cell Bank Program.
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It is crucial to disclose several kinds of information to the potential donor, including who has access to the cord blood once it is donated, where it is stored, how it is stored, and how the donor's privacy is protected. Recommendation 5.1: Cord Blood Centers Need Policies Regarding Who Must Provide Consent.
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It is important that the determination of the final inventory size take into account clinical, policy, and economic interests. To more clearly assess the relationship between HLA matching and the inventory size, the committee conducted its own outcomes analysis using data available from NMDP, the New York Blood Center, and the Cord Blood Banking and Transplantation study conducted by the National Heart, Lung, and Blood Institute.
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Recommended Structure of a National Program The committee's central charge was to advise HRSA on how a National Cord Blood Stem Cell Bank Program should be structured. The committee believes that the primary goal of any structure that is created should be to provide transplant physicians the assurance that when they determine that an HPC transplant from an unrelated donor is appropriate, the process for locating the best available cells is accurate and timely; that the procured cells are of high quality; and that information on the clinical experience of the transplant recipient is subsequently collected for ongoing research, quality assurance, and clinical improvement purposes.
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While many aspects to be performed by the proposed National Cord Blood Stem Cell Bank Network have analogs in the NMDP not all U.S.
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Cord Blood Banks wishing to participate in the National Cord Blood Program Bank Selection should meet the standards to be established by the National Board and must meet all data requirements of the national program. Standards Quality standards for banks, donor centers, and transplant centers will be set by an accrediting agency that is independent of the National Cord Blood Center.
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The committee urges the board to play an active role in ensuring that the lessons learned during the development and growth of NMDP, the COBLT study, and the solid-organ transplant program are appropriately applied to all funding and policy decisions about the National Cord Blood Stem Cell Bank Program. Recommendation 7.2: Establish a National Cord Blood Coordinating Center.
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The shaded portions of the diagram illustrate components that will have to be newly created, whereas the other portions represent existing components of the structure. DHHS National Cord Blood Office of the Secretary Advisory Board FDA HRSA Accrediting Body National Cord Blood Coordinating Center Search Outcomes Cord Blood Bank Transplant Collection Centers Centers Oversight Funding FIGURE ES-1 Proposed structure of a national program.
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Outcomes Data Recommendation 7.3: Develop an Outcomes Database for all Sources of HPCs. The National Board should support the development of an out comes database that can guide decisions on inventory size and track cord blood bank quality and other policies as well as assist with the assessment of outcomes from all sources of hematopoietic progenitor cells.
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Expansion of the current inventory with units that meet established standards should receive the highest priority in the near future. The National Board should offer support to participating banks that are designing expansion plans for their inventories to include cord blood units from racially and ethnically diverse populations, thus enhancing access to cord blood for individuals who are members of racial and ethnic minority groups.
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Only accredited banks and transplant centers should be able to participate in the National Cord Blood Stem Cell Bank Program. As recommended above (Recommendation 4.4)
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. Inventory of a National Cord Blood Stem Cell Bank Program Establish a national inventory policy (Recommendation 6.1)
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