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H H S Department of Health and Human Services
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Blood Cell Transplant

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Full Consensus Recommendations 17-21

Advisory Council on Blood Stem Cell Transplantation (ACBSCT) Consensus Recommendations to the Secretary of Heath and Human Services (HHS)

The ACBSCT met on November 8, 2011, and unanimously agreed on its seventeenth, eighteenth, nineteen, twentieth, and twenty-first recommendations.

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Recommendation 17

The Council recommends to the Secretary that the U.S. Food and Drug Administration(FDA) recognize and accept laboratory-developed testing performed in Clinical Laboratory Improvement Act(CLIA)-certified, high complexity histocompatibility laboratories.

Recommendation 18

The Council recommends that FDA broaden the investigational new drug(IND) and biologics license application(BLA) clinical indications for unrelated donor cord blood transplantation to include use for hematopoietic and/or immune reconstitution or enzyme replacement in any situation where hematopoietic stem cell transplantation(HSCT) is the appropriate approach to treatment. This would allow licensed cord blood units(CBUs) and CBUs distributed under IND to be used according to appropriate transplant patient and donor selection that occurs as part of the practice of transplantation medicine and would avoid the need to update lists for indications in this rapidly evolving field.

Recommendation 19

The Council recommends that all cord blood products have the same IND and BLA clinical indications; this is scientifically and medically sound.

Recommendation 20

The Council recommends implementation of a transition plan, initially stated as on or before October 20, 2011, to allow time for the FDA to review recommendations 17 and 18 above and to allow for implementation of any changes by transplant centers who will need to put these changes through their institutional review boards. During this transition period, the FDA can continue to exercise regulatory discretion for patients in need of a cord blood donor for transplantation. This would result in less disruption of medical care and will not limit access to cord blood transplants.

Recommendation 21

The Council recommends that CBUs collected through distribution of kits sent to motivated maternal donors or obstetrical units collected by an obstetric provider, which meet all National Cord Blood Inventory(NCBI)/FDA qualifications be eligible for listing on the NCBI and for FDA licensure.