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

Trial ID or NCT#

NCT01351545

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Andrew Rezvani, M.D.
Andrew Rezvani, M.D.
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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Contact

Sandhya Kharbanda, MD