First Cord Blood Product Gets FDA Stamp of Approval

FDA approves cord blood product HEMACORD

(RxWiki News) For the first time, U.S. Food and Drug Administration officials have given the green light to an umbilical cord blood product that could be used in stem cell transplants for patients with blood cancer, or metabolic or immune disorders.

The approved product called Hemacord, manufactured by the New York Blood Center, Inc., is a hematopoietic progenitor cells-cord cell therapy that would be used in procedures that affect the blood forming system.

"Ask your doctor if this option may be right for you."

Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said that the use of the cord blood product "offers potentially life-saving treatment options for patients with these types of disorders.”

Hemacord contains hematopoietic progenitor cells -- those that can regenerate themselves -- from human cord blood. The cells could be infused into the blood streams of patients, where they would remain in bone marrow to divide and mature. Those newly matured cells could then partially or totally restore function of many blood cells, including the function of the immune system.

Hemacord was approved following a review of safety and efficacy data. It will carry warnings regarding the risks of Graft Versus Host Disease, engraftment syndrome, graft failure, and infusion reactions. Those risks could be deadly in some patients.

Administration of Hemacord is recommended to occur only under the supervision of a doctor experienced in such stem cell transplants. Patients also should be carefully monitored while receiving the cord blood product.


Review Date: 
November 10, 2011