Tuesday, December 20, 2005

President Signs 'Stem Cell Therapeutic and Research Act of 2005'

President Signs 'Stem Cell Therapeutic and Research Act of 2005'

President George W. Bush smiles as he signs into law H.R. 2520, the Stem Cell Therapeutic and Research Act of 2005, during ceremonies Tuesday, Dec. 20, 2005, in the Roosevelt Room of the White House. White House photo by Paul Morse.President George W. Bush smiles as he signs into law H.R. 2520, the Stem Cell Therapeutic and Research Act of 2005, during ceremonies Tuesday, Dec. 20, 2005, in the Roosevelt Room of the White House. White House photo by Paul Morse.
On December 20, 2005, the President has signed into law:

H.R. 2520, the "Stem Cell Therapeutic and Research Act of 2005", which creates a new Federal program to collect and store cord blood, and expands the current bone marrow registry program to also include cord blood.

# # # For Immediate Release, Office of the Press Secretary, December 20, 2005

Stem Cell Therapeutic and Research Act of 2005 - (Sec. 2) Requires the Secretary of Health and Human Services to contract with qualified cord blood stem cell banks to assist in the collection and maintenance of human cord blood to be made available for transplantation through the C.W. Bill Young Cell Transplantation Program. Requires the Secretary to require that recipients of such contracts: (1) acquire, tissue-type, test, cryopreserve, and store donated units of human cord blood acquired with the informed consent of the donor in a manner that complies with applicable federal and state regulations; (2) make collected cord blood units available for stem cell transplantation or, if not appropriate for clinical use, available for peer-reviewed research; and (3) submit data for the Program and for inclusion in the stem cell therapeutic outcomes database. Limits such contracts to three years unless the Secretary: (1) finds that an inadequate amount of high-quality human cord blood has not been collected; and (2) does not receive an application from a cell bank that has not entered into such a contract or the Secretary determines that outstanding inventory need cannot be met by the one or more qualified cord blood stem cell banks that have submitted an application.

(Sec. 3) Amends the Public Health Service Act to rewrite provisions requiring the Secretary to establish and maintain a National Bone Marrow Donor Registry to require the Secretary, acting through the Administrator of the Health Resources and Services Administration (HRSA), to establish and maintain the C.W. Bill Young Cell Transplantation Program to increase the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow and cord blood. Requires the Secretary to establish an Advisory Council to advise the Secretary on matters related to Program activities. Sets forth reporting requirements.

Requires the Program to: (1) operate a system for identifying, matching, and facilitating the distribution of donated cord blood units; (2) allow transplant physicians, health care professionals, and patients to search by electronic means for available cord blood units; (3) support studies and demonstration and outreach projects for the purpose of increasing cord blood donation to ensure a genetically diverse collection of cord blood units; and (4) carry out information and educational activities for the purpose of increasing cord blood donation and promoting the availability of cord blood units as a transplant option.

Requires the Secretary to establish and maintain a scientific database of outcome information relating to patients who have been recipients of stem cell therapeutics product from a biologically unrelated donor (replacing provisions establishing a bone marrow scientific registry).

Authorizes appropriations.

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