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. The Stem Cell Act 2005 is managed by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS). The Stem Cell Act 2005 includes the:
- C.W. Bill Young Cell Transplantation Program (Program). Congressman C.W. Bill Young is a long-time supporter of bone marrow transplantation. Congressman Young's devoted efforts helped start the National Bone Marrow Donor Registry. The Program expands upon the previous requirements of the Registry to increase the number of marrow donors and cord blood units and continues to serve patients who need a bone marrow or cord blood transplant.
- National Cord Blood Inventory (NCBI). The NCBI cord blood banks will collect and store 150,000 cord blood units to treat patients. The NCBI banks will also provide cord blood units for research studies.
The law also requires an Advisory Council on Blood Stem Cell Transplantation (Advisory Council), which is being developed. The Advisory Council will make recommendations on issues about the Program to the Secretary of the HHS.
A bone marrow or cord blood transplant (also called a BMT) may be able to save the lives of some people who have a blood cancer (such as leukemia or lymphoma), or a metabolic or immune system disorder. A bone marrow or cord blood transplant replaces a patient's diseased blood-forming cells with healthy ones.
The Program
The Program
To help more patients have a successful bone marrow or cord blood transplant, the Program has four components, each with its own contract.
- Office of Patient Advocacy (OPA) and Single Point of Access (SPA)
- The Office of Patient Advocacy 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 cord blood units. Doctors, transplant center coordinators as well as patients and their families can use this system to search the Registry.
- The Bone Marrow Coordinating Center recruits potential marrow donors and works with the Program’s network of organizations throughout the transplant process.
- The Cord Blood Coordinating Center matches cord blood units. It also works with its network of cord blood banks, including banks that hold NCBI contracts, to recruit expectant parents for umbilical cord blood and to distribute cord blood units.
- The Stem Cell Therapeutic Outcomes Database collects and uses data from the Program's organizations and other organizations for research. The research helps define and refine all aspects of bone marrow and cord blood transplantation to help more patients live longer, healthier lives.
Program Builds on Its Predecessor
The Program continues the work of the National Bone Marrow Donor Registry, which helps patients who need unrelated marrow donors or cord blood units for a transplant. In addition, the Program expands data collection and cord blood activities as well as enhances patient access, patient advocacy and search efficiency.
The National Marrow Donor Program® (NMDP) operated the National Bone Marrow Donor Registry under a Federal contract. The NMDP and the Center for International Blood and Marrow Transplant Research® (CIBMTR) continue this work through their current contracts with the C.W. Bill Young Cell Transplantation Program.
Accountability
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.
To accomplish these overall goals, each of the four components has its own contract with specific goals. The Program will assess the goals of each component annually. Requirements common to all Program components are:
- To meet with project officers 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.
NCBI
The Stem Cell Act 2005 also requires the Secretary of the HHS to contract with qualified public cord blood banks to obtain 150,000 cord blood units. These cord blood units must meet specific criteria and will be available for transplantation through the Program.
Sometimes cord blood units do not meet transplantation criteria; these cord blood units may be available for research or discarded.
