Vaccines, Blood & Biologics
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Review, November 10, 2011 - Hemacord
I have considered the reviews which evaluated data from the docket and other sources, as well as the discussion at the Advisory Committee meeting of the CTGTAC held on 9/22/2011 to discuss this application. Although hematopoietic recovery, following transplantation with HPC-C, varies by disease and other clinical factors, as well as factors associated with the graft, the data demonstrate that cord blood can be used as a source of hematopoietic progenitor cells for transplantation. Data in a variety of disease indications demonstrates that this hematopoietic recovery is associated with benefit to selected patients. For these reasons, the above indication is appropriate. However, because of the risks including graft failure, GVHD, engraftment syndrome, and infusion reactions, careful consideration of patient and graft characteristics, and other available treatments, should be incorporated in selection of this treatment option for an individual patient, and this information will be incorporated into the label.