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

ID#: NCT01351545

Age: Birth - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: October 01, 2011

Contact Information:
Shannon Clark, MS
Summary: 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