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

• Status: Recruiting
• Trial end date: 2041-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for International Blood and Marrow Transplant Research
• Collaborator: National Marrow Donor Program

Criteria

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