Investigational New Drug Status for Cord Blood
Effective October 20, 2011, all requests to distribute cord blood units for transplantation in the United States are subject to FDA licensure requirements as a biologic drug, categorized as licensed or unlicensed. Transplant centers will only be able to access unlicensed cord blood units under an FDA-accepted Investigational New Drug application.
Gift of Life is a member cord blood bank of the National Marrow Donor Program (NMDP). The NMDP has sponsored an FDA-accepted IND and Gift of Life has met all NMDP supplier qualification and contractual requirements. As a result, Gift of Life has been approved for participation in the NMDP-sponsored IND to allow transplant center access to its inventory, which is classified as unlicensed.
Under the NMDP-sponsored protocol, the transplant centers are considered the clinical trial sites, the transplant center medical directors are considered the principal investigators, the transplant recipients are considered the research subjects and the cord blood units are considered the test articles.