You asked for information on legislation on umbilical cord blood banks.

SUMMARY

A 2004 federal appropriations act (Public Law 108-199) makes $ 10 million available to establish a National Cord Blood Stem Cell Bank Program. It also directs that some of the appropriation be used to study and make recommendations concerning the cord blood program.

BACKGROUND

Cord blood, which is also called “placental blood,” is the blood that remains in the umbilical cord and placenta following birth and after the cord is cut. Cord blood is routinely discarded with the placenta and umbilical cord. The umbilical cord blood is a valuable source of stem cells, which are genetically unique to the baby and family.

FEDERAL LEGISLATION

Funding Initiative

Title II of Public Law 108-199 (“Consolidated Appropriations Act, 2004”) includes $ 10 million to establish a National Cord Blood Stem Cell Bank within the Health Resources and Services Administration (HRSA, which is part of the federal Department of Health and Human Services. ) The funding remains “available until expended. ” The program will fund a network of cord blood banks with two specific aims: 1) building an inventory of the highest quality cord blood units for use as unrelated donor grafts for patients who lack human leukocyte antigen (HLA)-matched sibling donors and 2) ensuring an integrated system through which physicians and patients are able to locate a suitably matched cord blood unit or adult volunteer bone marrow donor via a single, electronic access point. The House and Senate conferees on this legislation intend that the program be administered by HRSA (see Conference Report to Accompany H. R. 2673, Report 108-401, p. 751).

Institute of Medicine Study

Because this is a “new and developing field,” the conferees direct HRSA to use $ 1 million of the funds to contract with the Institute of Medicine (IOM) to commission a study to be completed within 12 months of the act’s enactment. The study, according to the conference report, “should recommend an optimal structure for the cord blood program and address pertinent issues to maximize the potential of this technology, including collection, storage, standards setting, information sharing, distribution, reimbursement, research, and outcomes measures” (conference report, p. 751).

The IOM is directed to receive information from a variety of experts including: (a) transplant physicians with expertise in the use of cord blood for unrelated marrow transplantation; (b) experts in the analysis of clinical outcomes after bone marrow and cord blood stem cell transplantation; (c) experts on HLA typing for transplantation; (d) experts in medical database development and management and web-based information technology; (e) obstetricians familiar with programs for cord blood donation for public use; (f) experts in cord blood banking; (g) representatives of existing federally funded and other active cord blood and bone marrow registries; (h) Food and Drug Administration (FDA) representatives; (i) experts in the accreditation of facilities for cord blood stem cell preparation and transplantation; and (j) representatives of the National Institutes of Health (NIH) Cord Blood Transplantation Study (pp. 751-752).

The conference report on this legislation also states, “the conferees understand that cord blood is part of a continuum of transplantation treatment and support further research in cord blood transplantation. A portion of the cord blood units collected using these funds should be available for the performance of pre-clinical and clinical research

focusing on cord blood stem cell biology and the use of umbilical cord blood stem cells for human transplantation and cellular therapies” (p. 752).

The conferees also intended that the program be available to currently established cord blood banks with active collection programs operating under FDA approval.

JK: ro