Clinical Trial

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

This research is designed to provide access to, and distribution of cord blood units (CBUs) to different bone marrow transplant centers. In some life threatening diseases, the use of CBUs in transplant is the best available option. Since 1989, Cord blood banks have been established worldwide and over one million cord blood collections have been performed. In October 2011, the Food and Drug Administration (FDA) began considering cord blood as one of the choices for transplant and regarded as a biological drug. In the United States, drugs must meet standards set by the FDA to make sure they are safe and effective. About 90% of the CBUs that are currently available in cord blood banks in the United States and other countries were collected before the FDA set these new standards. Although these CBUs may not meet FDA standards, they do meet similar standards set and followed by the National Marrow Donor Program (NMDP) for years. This study protocol will allow both U.S. and international cord blood banks to distribute already collected cord blood units as an Investigational New Drug (IND) as long as they meet requirements established by the NMDP.

• Immune System
• Lymphatic System
• BMT
• Cord Blood