CLINICAL TRIAL / NCT01351545

Principal Investigators:

     The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers.

     Study Design:

     This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

     Primary Objective:

     The primary objective of this study is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.

     Secondary Objectives:

     In patients receiving a non-licensed CBU:

        - Assess incidence of transmission of infection

        - Assess incidence of serious infusion reaction

        - Determine 1 year overall survival after cord blood transplantation

        - Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and grades III to IV

        - Assess cumulative incidence of chronic GVHD

        - Determine platelet engraftment of >20,000 mcL and >50,000 mcL

Inclusion Criteria:

         - Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment

         - Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment

         - Pediatric and adult patients of any age

        Exclusion Criteria:

         - Patients who are receiving only licensed CBUs

         - Cord blood transplant recipients at international transplant centers

         - Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)

         - Patients whose selected unlicensed CBU(s) will be more than minimally manipulated