National Cord Blood Inventory

Authorizing Legislation: Section 379 of the Public Health Service Act, as amended by the Public Law 109-129.

Program Description and Accomplishments
The primary goals of the National Cord Blood Inventory (NCBI) are to build a genetically and ethnically diverse inventory of 150,000 new units of high-quality umbilical cord blood for transplantation and to make these cord blood units, as well as other units in the inventories of participating cord blood banks, available to physicians and patients for blood stem cell transplants through the C.W. Bill Young Cell Transplantation Program (the Program). Additionally, the NCBI program will make cord blood units available for preclinical and clinical research focusing on cord blood stem cell biology and the use of cord blood stem cells for human transplantation and cellular therapies. The NCBI program will also establish a Related Cord Blood Donor Demonstration Project. The NCBI works towards achieving these goals by providing funds for reimbursement for the collection and storage of qualified cord blood units by a network of cord blood banks in the United States.

Blood stem cell transplantation offers the possibility of a cure for Americans with leukemia and other life threatening blood and genetic disorders. Blood stem cells for these transplants can be obtained from the bone marrow or circulating blood of volunteer adult donors, or collected by the newest source, the umbilical cord and placenta after a normal birth. Each year approximately 38,000 people under the age of 55 are diagnosed with these fatal illnesses, and about 16,000 of them cannot be successfully treated with therapy other than a blood stem cell transplant. When doctors have a patient in need of transplantation, they initially try to locate donors related to the patient. If none are available, as is the case for approximately 70 percent of patients, they need to search for a suitable unrelated donor or umbilical cord blood unit.

The tissue types of blood stem cell donors must be closely matched with those of their recipients in order for the transplant to be successful. Since tissue types are inherited, patients are more likely to find a closely matched donor within their own racial and ethnic group. However, due to the high rate of diversity in the tissue types of minorities, especially African-Americans, minorities are less likely to find a suitably matched adult marrow donor on the Registry of the C.W. Bill Young Cell Transplantation Program. To date, the majority of cord blood transplants have been performed on pediatric recipients because of the smaller number of stem cells present in cord blood, although increasingly cord blood also is being used for adult recipients. Because it can be used with a less perfect match in tissue type between donor and recipient than is the case for adult marrow donors, cord blood offers a chance of survival for patients who lack a suitably tissue-matched relative and who cannot find an adequately matched unrelated adult donor through the Program or through international adult donor registries. Minority patients, especially African-American patients, are especially likely to benefit from additional cord blood units. For these reasons, the NCBI continues to emphasize increasing the number of cord blood units collected from minority donors.

Contract opportunities for the NCBI are announced nationally and proposals are then reviewed by technical committees composed of individuals who are qualified by training and experience in particular fields related to blood stem cell transplantation and cord blood banking. Funding decisions are made based on committee assessments of technical merit, overall quality, ability to collect from diverse populations, geographic dispersion of offerors, evaluation of past performance, and evaluation of proposed costs. When exercising option years beyond the original base period of contracts, current performance and compliance with contract terms is carefully considered. By statute, no more than 5 percent of the appropriation for the NCBI in any given year can be used for the Related Cord Blood Donor Demonstration Project. In future competitions for contracts, HRSA will place particular emphasis on the demonstrated ability of offerors to collect and bank large numbers of cord blood units from African-American donors.

HRSA awarded contracts to the first cohort of umbilical cord blood banks collecting for the National Cord Blood Inventory in November 2006. Six banks were awarded contracts at that time. In September 2007, a second cohort consisting of two banks was added to the program and a second year of funding was provided to the first cohort of banks. At the same time, HRSA also awarded funds to four of the NCBI banks to participate in the Related Cord Blood Donor Demonstration Project for the purpose of collecting and banking cord blood units for families in which a first-degree relative has been diagnosed with a condition that may benefit from transplantation. These actions used all of the funds appropriated for the program in FY 2004 – 2007. Approximately 22,280 units of umbilical cord blood will be collected with funds awarded in FY 2007. HRSA anticipates that approximately 6,500 additional units of cord blood will be collected with funds awarded in FY 2008.

In general, cord blood units in any given inventory do not come up for match to a patient until the size of the inventory has met a critical threshold in terms of the number of units in the inventory. Despite this fact, during the first year of collections for the NCBI (FY 2007), four cord blood units from this small inventory were released for transplantation and many other units are currently under evaluation for use by patients in need of transplant. The value of large cord blood units, such as those collected with HRSA funds, is demonstrated by the fact that all four of the cord blood units released for transplantation had total nucleated cell counts well above the levels generally available prior to implementation of the NCBI program.

The diverse units comprising the National Cord Blood Inventory will serve an increasing number of patients from populations that have difficulty obtaining cells from a well-matched adult donor. Of the cord blood units collected with funds awarded in FY 2007, approximately 67 percent will be from racial and ethnic minorities. Approximately 20 percent will be from African-American donors.

Indicators of the increasing importance of cord blood in general, and specifically the NCBI, include the fact that approximately 50 percent of the additional transplants facilitated through the
C.W. Bill Young Cell Transplantation Program in FY 2007 over the previous fiscal year utilized umbilical cord blood as the source of stem cells for transplantation. As evidence of the value of cord blood and the NCBI in terms of increasing access to transplantation for underrepresented populations, nearly 30 percent of the minority transplants facilitated through the C.W. Bill Young Cell Transplantation Program in FY 2007 used umbilical cord blood and nearly 40 percent year to date (FY 2008) have utilized umbilical cord blood as the stem cell source for transplantation.

Funding includes costs associated with grant reviews, processing of grants through the Grants Administration Tracking and Evaluation System (GATES) and HRSA’s electronic handbook, and follow-up performance reviews.

Funding History

Budget Request
The FY 2009 Budget request of $11,966,000 is an increase of $3,123,000 over the FY 2008 Enacted level. Approximately 8,650 new units of cord blood will be collected with the funds requested for FY 2009 for a total of approximately 37,280 units from all funds awarded in FY 2004-2009.

The entire FY 2009 Budget request will support the Program’s continued progress toward its central goal of building a genetically diverse inventory of 150,000 new units of high-quality umbilical cord blood for transplantation. Additionally, this Budget request will support the final year of funding for the related cord blood donor demonstration project called for by the authorizing legislation.

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