Legislation & Contracts
The Stem Cell Therapeutic and Research Act of 2005 (Stem Cell Act 2005) was passed by Congress and signed by President Bush in December 2005 as Public Law 109-129. In October 2010, President Obama signed the Stem Cell Therapeutic and Research Reauthorization Act of 2010, Public Law 111-264 (Stem Cell Act 2010). The Stem Cell Acts of 2005 and 2010 are managed by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS). The Stem Cell Acts include the:
- C.W. Bill Young Cell Transplantation Program (Program). Congressman C.W. 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 Program expanded on the previous requirements of the registry to increase the numbers of marrow donors and cord blood units, and continues to serve patients who need a bone marrow or umbilical cord blood transplant. The Program 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 Act 2010 also required the U.S. Government Accountability Office to report on efforts to increase cord blood unit collection for the NCBI.
The law also requires an Advisory Council on Blood Stem Cell Transplantation to make recommendations on issues about the Program to the Secretary of the HHS.
A bone marrow transplant (also called a BMT) or umbilical cord blood transplant may be able to save the lives of some people who have a blood cancer (such as leukemia or lymphoma) or an inherited metabolic or immune system disorder. A bone marrow or cord blood transplant replaces a patient's diseased blood-forming cells with healthy ones.
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The Program builds on the work of the National Bone Marrow Donor Registry, which was established in 1987. The Program was established in September 2006 with broader objectives and continues to help patients have a successful bone marrow or cord blood transplant.
There are four components of the Program.
- Office of Patient Advocacy (OPA) and Single Point of Access (SPA)
- The OPA component provides help, support, and understanding to patients and families facing the crisis of a life-threatening illness, from diagnosis through survivorship.
- A Single Point of Access means that one electronic system is used to search the registry for both unrelated marrow donors and donated cord blood units. Doctors, transplant center coordinators as well as patients and their families can use this system to search the registry. (The registry is a listing of unrelated marrow donors and donated cord blood units.)
- The Bone Marrow Coordinating Center matches donors with patients. It also recruits potential marrow donors, helps donors throughout the donation process, and works with its network of organizations throughout the transplant process.
- The Cord Blood Coordinating Center partners with cord blood banks to recruit expectant parents for umbilical cord donation; this includes its network of cord blood banks and banks holding National Cord Blood Inventory contracts. The CBCC also increases access to transplant by matching and facilitating distribution of donated cord blood units searched through the registry.
- The Stem Cell Therapeutic Outcomes Database collects and uses data about bone marrow and cord blood transplantation (which use blood-forming cells called stem cells) for research. The research helps define and refine all aspects of transplantation to help more patients live longer, healthier lives.
The four Program components work together for the overall goals of:
- Coordinating a national network that links transplant centers with the Program's donor centers and cord blood banks.
- Setting up and maintaining an electronic information system that facilitates searches and transplants.
- Collecting medical data so that research can improve procedures and help patients live longer, healthier lives.
To accomplish these overall goals, each of the four components has its own contract with specific goals and requirements. The Program assesses the goals and requirements of each component annually. Requirements common to all Program components are:
- To meet with representatives from HRSA and submit reports in a specified time frame.
- To have a board of directors and committees or a similar group of leaders.
- To collaborate with other Program contractors and advisory committees.
- To establish and maintain a systems security program.
For an overview of additional requirements for each Program component, see:
The Stem Cell Acts of 2005 and 2010 also require the Secretary of the HHS to contract with qualified public cord blood banks to obtain at least 150,000 new cord blood units. These cord blood units must meet specific criteria and are available for transplantation through the Program.
Sometimes cord blood units are not suitable for transplant (such as when the number of blood-forming cells is too few). Unsuitable cord blood units are either made available for research or they are discarded.
For an overview of the NCBI requirements, see National Cord Blood Inventory Contract Summary.