In 1987, the National Bone Marrow Donor Registry (NBMDR) was initiated through a congressionally-directed grant from the U.S. Department of the Navy and formally established in 1990 as a responsibility of the U.S. Department of Health and Human Services (HHS), with oversight initially by the National Institutes of Health (National Heart, Lung, and Blood Institute) and, since 1994, by the HHS Health Resources and Services Administration (HRSA).
In December 2005, Congress passed the Stem Cell Therapeutic and Research Act (Stem Cell Act 2005), Public Law 109-129. The Stem Cell Act 2005 amended the Public Health Service Act and required the HHS Secretary, through HRSA, to rewrite the provisions that established and maintained the NBMDR. The provisions were rewritten to establish and maintain the C.W. Bill Young Cell Transplantation Program (CWBYCTP), the successor to the NBMDR. The Stem Cell Therapeutic and Research Reauthorization Act of 2010 (Stem Cell Act 2010), Public Law 111-264, was signed in December 2010, the Stem Cell Therapeutic and Research Reauthorization Act of 2015 (Stem Cell Act 2015), Public Law 114-104, was signed in 2015, and the Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act of 2021, Public Law 117-15, was signed in 2021.
The Stem Cell Acts of 2005, 2010, 2015, 2021 authorize the following:
- C.W. Bill Young Cell Transplantation Program (CWBYCTP). Congressman Charles William Bill Young was a long-time supporter of bone marrow transplantation. Congressman Young's devoted efforts helped start the National Bone Marrow Donor Registry. The Stem Cell Therapeutic and Research Act of 2005 established the CWBYCTP to replace the NBMDR. In so doing, the Act expanded on the previous requirements of the NBMDR to increase the numbers of marrow donors and cord blood units, and continued to serve patients who need a bone marrow or umbilical cord blood transplant. The CWBYCTP also established an outcomes database to collect data and perform research.
- National Cord Blood Inventory (NCBI). The goal of the NCBI cord blood banks is to collect and store at least 150,000 new cord blood units to treat patients. The NCBI banks will also provide cord blood units for research studies. The Stem Cell Therapeutic and Research Reauthorization Acts of 2010 also required the U.S. Government Accountability Office to report on efforts to increase cord blood unit collection for the NCBI.
- Advisory Council on Blood Stem Cell Transplantation (ACBSCT). The goal of the ACBSCT is to advise, assist, consult with, and make recommendations to the Secretary of Health and Human Services and the Administrator of HRSA on matters carried out by both CWBYCTP and the NCBI Program.
Reports to Congress
The Stem Cell Therapeutic and Research Reauthorization Act requires the Secretary of HHS, through HRSA, to submit to Congress an annual report on the activities of the CWBYCTP, NCBI, and ACBSCT.