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

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

Category:

Supportive Bone Marrow Transplant Studies

Eligibility Overview:

This is a non-therapeutic clinical trial that is only open to St. Jude patients.

  • 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.

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

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.