109th Congress

Stem Cell Therapeutic and Research Act of 2005

P.L. 109-129 (H.R. 2520, S. 1317)

Impact of Public Law

P.L. 109-129 focuses on enhancing and expanding the clinical use of stem cells derived from umbilical cord blood. These particular stem cells, also found in blood and bone marrow, can both renew themselves and differentiate into several other specialized types of cells. Umbilical cord tissue supports the developing fetus during pregnancy, is delivered along with the baby, and is usually discarded. Since the first successful umbilical cord blood transplants in children with bone marrow failure, such as in Fanconi’s anemia, the collection and therapeutic use of these cells has rapidly increased.

P.L. 109-129 does not have a direct impact on the National Institutes of Health. The legislation requires the Secretary of Health and Human Services, acting through the Director of the Health Resources and Services Administration, to establish the C.W. Bill Young Cell Transplantation Program, a network of cord blood banks, to facilitate the use of cord blood for transplantation purposes. It also requires that any cord blood units collected that are not appropriate for clinical use be made available for peer-reviewed research. In addition, the Secretary is required to, by contract, establish and maintain a “stem cell therapeutic outcomes database,” which would contain scientific information relating to patients who have received a “stem cell therapeutics product” (including bone marrow, cord blood, or other such products) from a biologically unrelated donor. The nonidentifiable information in the database will be available to the public in the form of summaries and datasets in order to encourage medical research and provide information to transplant programs, physicians, and cord blood stem cell banks.

Legislative History

H.R. 2520 was introduced by Representative Christopher H. Smith (R-NJ) on May 23, 2005. The bill was passed by the House on May 24 by a vote of 431 to 1. On December 16, it was passed by the Senate with an amendment by Unanimous Consent. The amended version was passed by the House on December 17 under suspension of the rules. The President signed the bill on December 20 as P.L. 109-129.

S. 1317 was introduced by Senator Orrin G. Hatch on June 27, 2005. The bill was reported out of the Senate Committee on Health, Education, Labor and Pensions on July 11 with an amendment in the nature of a substitute. S. 1317 was the companion measure to H.R. 2520, although there were minor differences between the two bills. No further action has occurred on this legislation.