10-CBA: A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Description

Patients enrolled in this access and distribution protocol may receive unlicensed Cord Blood units (CBU) for their transplantation.

Beginning October 2011, the FDA considers cord blood as a biological drug. Cord blood units (CBU) that were not collected, tested, or stored exactly according to FDA standards may be used for transplant if the transplant is done as part of a study. Most of the CBUs that are currently available in CB banks in the US and other countries were collected before the FDA set these new standards. Although these CBUs may not meet FDA standards, they meet similar standards set and followed by the National Marrow Donor Program (NMDP) for years.

Objectives

• The primary objective of this study is to examine the incidence of neutrophil recovery after cord transplantation.

In participants receiving a non-licensed CBU:

• To determine the frequency of graft rejection.
• To determine the frequency of infection.
• To determine the frequency of serious infusion reaction.
• To determine the 1 year survival rate.

Eligibility

• Only current St. Jude patients are eligible for non-therapeutic studies.
• Participant is receiving an allogeneic hematopoietic stem cell transplant at St. Jude Children’s Research Hospital using an unlicensed cord blood unit (CBU).
• The patient has a disorder affecting the hematopoietic system that is either inherited, acquired, or a result from myeloablative treatment.

Principal Investigator

Renee Madden, MD