108th Congress

Stem Cells Derived From Umbilical Cord Blood

H.R. 2852, S. 1717

Background

In the late 1980s and early 1990s, physicians began to recognize that blood from the human umbilical cord and placenta was a rich source of hematopoietic stem cells (HSCs). 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 quickly increased. Many children have had their lives extended due to umbilical cord blood transplants. There is also a substantial amount of research being conducted on umbilical cord blood in order to find ways to expand the number of HSCs and compare the biological properties of cord blood stem cells with adult bone marrow stem cells. (See Stem Cells: Scientific Progress and Future Research Directions, July 2001, prepared by the National Institutes of Health, http://stemcells.nih.gov/stemcell/scireport.asp.)

The continuing public interest in all types of stem cells has generated increased congressional attention to the possible clinical uses of umbilical cord blood. On June 12, 2002, the Senate Commerce, Science and Transportation Subcommittee on Science, Technology and Space (Senator Sam Brownback [R-KS], Chair) held a hearing entitled “Advances in Adult and Non-Embryonic Stem Cell Research.” At this hearing, witnesses 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 these stem cells available. To address some of these concerns, the report accompanying the Senate version of the fiscal year (FY) 2004 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Bill (S. Rept. 108-81, accompanying S. 1356, page 60) provides funds for the Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services to operate a National Cord Blood Stem Cell Bank. The report included the following language:

“. . . the Committee has provided $10,000,000 to create a National Cord Blood Stem Cell Bank with the aim of building an inventory of the highest quality, fully characterized cord blood units for use as unrelated donor grafts for patients who need transplantation therapy but lack suitably matched conventional bone marrow donors. The Committee understands that this Cord Blood Stem Cell Bank will serve patients suffering from high risk and refractory malignancies (leukemia, lymphoma, myelodysplasia, neuroblastoma), congenital and acquired bone marrow failure syndromes (aplastic anemia, Fanconi anemia), congenital immunodeficiency syndromes (SCID, Wiscott-Aldrich Syndrome, CID), inborn errors of metabolism, and hemoglobinopathies (sickle cell anemia and thalassemia).”

The FY 2005 Consolidated Appropriations Act (P.L. 108-447) includes $9,941,000 to continue the National Cord Blood Stem Cell Bank.

On July 24, 2003, Representative Christopher H. Smith (R-NJ) introduced H.R. 2852, the Cord Blood Stem Cell Act of 2003. In an accompanying press release, Representative Smith stated that “by significantly increasing the Nation’s supply of genetically diverse cord blood units, treatment for several diseases such as sickle cell anemia, leukemia, lymphoma, and other blood and immune deficiency diseases will be more widely available to the American people.” Senator Orrin G. Hatch (R-UT) introduced a similar bill, S. 1717, on October 3, 2003.

Provisions of the Legislation/Impact on NIH

• The bill 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) that contains 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.
• The Network would have been required to allocate up to 10 percent of the cord blood inventory each year for peer-reviewed research.
• The Secretary of Health and Human Services would have been required to establish a Board of Directors to administer the Network, which would have included scientific experts, stem cell transplant recipients and their families, and members of the general public.

Status and Outlook

H.R. 2852 was introduced by Representative Smith on July 24, 2003, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 108th Congress.

S. 1717 was introduced by Senator Hatch on October 3, 2003, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action occurred on this legislation during the 108th Congress.