A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

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.

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

Conditions:
• Hematologic Neoplasms
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Disease
• Hodgkin Disease
• Lymphoma, Non-Hodgkin
• Autoimmune Diseases
• Anemia, Aplastic