Non-Therapeutic Protocol

10-CBA: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units for transplantation in pediatric and adult patients with hematologic malignancies and other indications

Type of Protocol/Clinical Study

Associated Stem Cell Transplant Studies

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

In participants receiving a non-licensed CBU:


Eligibility

Principal Investigator

Mari Dallas, MD


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.