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.

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

Recipients of unlicensed cryopreserved cord blood units who are being treated as U.S. transplant centers.