109th Congress

Stem Cells Derived From Umbilical Cord Blood

H.R. 596/S. 681, H.R. 2520/S. 1317

Background

In the late 1980s and early 1990s, physicians began to recognize that blood from the human umbilical cord and placenta is a rich source of hematopoietic stem cells. These particular stem cells are found in blood and bone marrow and can both renew themselves and differentiate into other specialized types of cells. This 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 anemia, the collection and therapeutic use of these cells has rapidly increased. Many children have had their lives extended due to umbilical cord blood transplants.

The continuing public interest in the subject of stem cells has generated increased congressional attention to the possible clinical uses of umbilical cord blood. Witnesses at several congressional hearings in recent years have testified about promising research involving cord blood stem cells, transplantation challenges in the therapeutic use of such stem cells, and the need for a national cord blood bank that would make such stem cells available. To address some of these concerns, the fiscal year (FY) 2004 Labor, Health and Human Services and Education and Related Agencies Appropriations Bill provided funds for the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) to operate a National Cord Blood Stem Cell Bank. Similar language was included in the FY 2005 appropriations bill.

During the 108th Congress, Representative Christopher H. Smith (R-NJ) introduced legislation to require HRSA to establish and maintain a network of cord blood stem cell banks. When the 109th Congress convened, he reintroduced this legislation as H.R. 596. A companion bill, S. 681, was introduced shortly thereafter by Senator Sam Brownback (R-KS).

On May 24, 2005, during consideration of H.R. 810 (see the article on human embryonic stem cell research), Representative Smith introduced a similar bill, H.R. 2520, the Stem Cell Therapeutic and Research Act of 2005. This bill was passed by the House by a vote of 431 to 1. A companion bill, S. 1317, was introduced by Senator Orrin G. Hatch (R-UT) on June 27. The Senate passed an amended version of H.R. 2520 on December 16. This version was passed by the House on December 17 and became P.L. 109-129.

Provisions of the Legislation/Impact on NIH

H.R. 596/S. 681

The legislation would have required the Administrator of HRSA to enter into contracts with qualified cord blood stem cell banks for the purpose of establishing and maintaining a National Network of Cord Blood Stem Cell Banks (the Network), which would have contained at least 150,000 units of human cord blood stem cells. The Network would have been required to make the collected cord blood units available to transplant centers and allocate up to 10 percent of the cord blood inventory each year for peer-reviewed research.

In addition, the Secretary of Health and Human Services (HHS) would have been required to establish a board of directors to administer the Network that would have included scientific experts, stem cell transplant recipients and their families, and members of the general public.

H.R. 2520/S. 1317

The legislation does not have a direct impact on the National Institutes of Health. It would require the Secretary of HHS, acting through the Administrator of HRSA, 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. In addition, the Secretary would be required to, by contract, establish and maintain a “stem cell therapeutic outcomes database.” The database 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 donor. The nonidentifiable information in the database would 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.

Status and Outlook

H.R. 596 was introduced by Representative Smith on February 2, 2005, and was referred to the House Committee on Energy and Commerce. As of April, it had 41 cosponsors. No further action occurred on this legislation during the 109th Congress.

S. 681 was introduced by Senator Brownback on March 17, 2005, and was referred to the Senate Committee on Health, Education, Labor and Pensions (HELP). As of April, it had four cosponsors. No further action occurred on this legislation during the 109th Congress.

H.R. 2520 was introduced by Representative Smith on May 23, 2005, and was passed by the House by a vote of 431 to 1 on May 24. The Senate passed an amended version of H.R. 2520 on December 16. This version was passed by the House on December 17 and became P.L. 109-129.

S. 1317 was introduced by Senator Hatch on June 27, 2005. It was reported out of the Senate HELP Committee on July 11 with an amendment in the nature of a substitute. S. 1317 is the companion measure to H.R. 2520, although there are minor differences between the two bills. No further action occurred on this legislation during the 109th Congress.