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C.W. Bill Young Cell Transplantation (CWBYCTP) Report to Congress

The Stem Cell Therapeutic and Research Act of 2005, Public Law (P.L.) 109-129, as amended by P.L. 111-264 (section 379(a)(6) of the Public Health Service Act) and P.L. 114-104, includes a requirement in section 3 which states, in part:

“The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall submit to the Congress an annual report on the activities carried out under this section.”

The annual report to Congress provides background information about the programs and advisory council authorized by the law, such as the C.W. Bill Young Cell Transplantation Program (CWBYCTP), the National Cord Blood Inventory (NCBI), and the Advisory Council on Blood Stem Cell Transplantation (ACBSCT). The report also describes the structure and operation of each program, including professional and public educational efforts and programmatic accomplishments, and provides statistical information about the programs from October 1st through September 30th. 

Below are the three most recent annual reports to Congress:

Stem Cell Therapeutic and Research Reauthorization (SCTaRRA) Report to Congress

In additional to the annual reports to Congress noted above, the Stem Cell Therapeutic and Research Reauthorization Act of 2015 (Public Law 114-104, Section 2(c)) required an additional report that was due by June 30, 2019. The additional report required that the Secretary of Health and Human Services, working with others, provide the United States Congress with a report regarding the appropriateness of the inclusion in the C.W. Bill Young Cell Transplantation Program (CWBYCTP) of adult stem cells and birthing tissues as new types of therapies for patients. 

The CWBYCTP currently facilitates access to potentially life-saving therapies that are generally accepted by the medical community as safe and effective: stem cells derived from blood, bone marrow, or cord blood used for hematologic or immunologic reconstitution. These uses of stem cells have been incorporated into professional guidelines for the management of many different diseases, and there are several cord blood products approved1 by the Food and Drug Administration (FDA) for use in hematologic and immunologic reconstitution. 

Stem cells derived from allogeneic (cells from one individual to another) and autologous (cells from one’s own body) bone marrow and peripheral blood, cord blood, as well as stem cells derived from adipose and other sources, are being investigated for the treatment of a wide variety of different conditions ranging from arthritis to neurologic disorders to cardiac diseases. In contrast to cellular products for hematologic and immunologic reconstitution, clinical trials have yet to demonstrate sufficient evidence to support the efficacy of such adult stem cells or stem cells derived from birthing tissues for the treatment of these diverse non-hematologic conditions. 

At this time, adult stem cells and birthing tissues as defined above fall into a different category of products: those that are investigational for their intended uses. Therefore, the report does not support the inclusion of such investigational uses into the CWBYCTP at this time but rather encourages reevaluation as the science advances.
Based on the considerations discussed above, and the evolution of the field of stem cell-based therapies, the Department of Health and Human Services (HHS) made the following recommendations:

The proposed criteria for inclusion of new cellular therapies in the CWBYCTP are that:

  1. The CWBYCTP should include only those adult stem cell and birthing tissue products, including those with new uses outside of hematologic or immunologic reconstitution, that:
    1. are utilized as treatments for serious or life-threatening conditions (1,2),
    2. require donor matching if appropriate, and
    3. have been demonstrated to be safe and effective as evidenced by FDA approval, or if FDA approval is not required, through adoption as a standard of care.
  2. Based on the criteria above, the inclusion in the CWBYCTP of adult stem cells and birthing tissues for uses other than hematologic and immunologic reconstitution is not recommended at this time.
  3. As the science advances and new classes of cell-based products are developed that meet regulatory approval standards for safety and efficacy, it may be appropriate to include such products in the CWBYCTP. Therefore, reevaluation by HRSA, NIH, and FDA (in conjunction with appropriate expert consultation) of the status of adult stem cells and birthing tissues for potential inclusion in the CWBYCTP is recommended on a periodic basis (every two to three years or as needed), with issuance of a report on the outcomes of these evaluations when relevant.

1 FDA approval to market a biologic is granted by issuance of a biologics license under section 351 of the Public Health Service Act. For the purposes of this report, we will use the terms “approval” and “licensure”, with respect to biological products, interchangeably.

*Persons using assistive technology may not be able to fully access information in this file. For assistance, please email or call Shelley Grant at (301) 443-8036.

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