The ACBSCT met on April 28-29, 2008, in Rockville, Maryland, and unanimously agreed on its first two consensus recommendations.
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ACBSCT recommends to the Secretary that the Food and Drug Administration (FDA) finalize its Draft Guidance for Industry on Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies. ACBSCT recommends that the FDA, in the final guidance, expand the scope of clinical indications, define reasonable guidelines for comparability, define rules and processes for use of non-U.S. cord blood units that will not impede clinical practice, and define rules for the transition period when some banks are licensed and some are not.
It is clear to ACBSCT members that FDA staff understand the important issues to be resolved in writing the final guidance and are hard at work on those issues. The Council urges completion of the final Guidance, and emphasizes that the final Guidance must not inadvertently impede access to life-saving cord blood units in its treatment of such issues as (a) the clinical indications for which a unit may be licensed; (b) ready access to high quality cord blood units already in the inventories of U.S. cord blood banks; and (c) imports of high quality cord blood units.
ACBSCT recommends that the Secretary of HHS increase funding of the Center for International Blood and Marrow Transplant Research’s (CIBMTR) U24 cooperative agreement with National Cancer Institute (NCI) (U24 CA 76518) during years 2-5 to levels at least equal to that requested by CIBMTR and recommended by the National Institutes of Health’s Scientific Review Committee.
This recommendation partially addresses the need for public funding in support of legislatively required data collection on the outcomes of marrow and cord blood transplants, Presentations to the Council among other things informed members of a reduction in NIH grant funding for transplant data collection. The Advisory Council is concerned that reduced funding for the CIBMTR by the National Cancer Institute (NCI) will have substantial adverse effects on the availability of data and the overall state of clinical research on hematopoietic cell transplantation (bone marrow, peripheral blood and cord blood). The Council is concerned that funding reductions at this time will preclude deployment to transplant centers of an electronic communication tool (AGNIS) carefully developed over several years to leverage the informatics infrastructure of the NCI’s caBIG system. The AGNIS system has the potential to greatly enhance the ability of centers to share data on transplant strategies and outcomes electronically and, by doing so, to significantly reduce the cost to transplant centers of compliance with the new legislative mandates for reporting of outcomes data, and to increase the scope of clinical research possible in this field in a cost-effective manner. The reduction also would preclude collection of important data on quality of life after transplant.