unlicensed cryopreserved cord blood units

Unlicensed cryopreserved cord blood units (CBUs) are biological products consisting of minimally manipulated hematopoietic stem cells derived from umbilical cord blood. Distributed under the 10-CBA protocol, which is a multicenter access and distribution study sponsored by the National Marrow Donor Program (NMDP) and the Center for International Blood and Marrow Transplant Research (CIBMTR), these units provide a source of total nucleated cells (TNC) and CD34+ hematopoietic stem cells for patients requiring transplantation. The primary therapeutic goal is hematopoietic reconstitution following myeloablative therapy. This protocol allows for the use of cord blood units that do not meet FDA licensure requirements but are suitable for transplantation in patients with life-threatening conditions, including hematologic malignancies (leukemias, lymphomas), inherited metabolic disorders, immune system disorders, hemoglobinopathies, bone marrow failure syndromes, histiocytic disorders, and inherited platelet abnormalities.

Other names

cord blood units-Center for International Blood and Marrow Transplant Research-hematologic malignancies-inherited metabolic disorders-immune system disorders-hemoglobinopathies-bone marrow failure-histiocytic disorders-inherited platelet abnormalitiesunlicensed cord blood unitsminimally manipulated unlicensed umbilical cord blood unitsCBUsunlicensed cryopreserved CBUs