U.S. drug regulators have for the first time approved a therapy that uses cells of human blood from the placenta and the umbilical cord to treat people with blood-forming disorders or cancer.
The Food and Drug Administration on Thursday licensed Hemacord, manufactured by the New York Blood Center (NYBC), a therapy that contains self-recreating cells similar to stem cells from human cord blood.
Those blood-forming types of cells, known as progenitor cells, are infused into patients and make their way to bone marrow, where they divide and mature. As they move into the bloodstream, they can help build new blood cells or restore their capacities, including immune function.
Hemacord is approved for use in blood-restoring stem cell transplants, which can use cells from three sources: cords, bone marrow, and peripheral blood, the flowing blood that circulates through the body.
"We have been using cord blood for years," said Dr. Machi Scaradavou, medical director of the NYBC's National Cord Blood Program. "Recently, FDA decided that it needs to be licensed and this is the first cord blood product and stem cell product to be licensed."
In 2009, the FDA guided manufacturers of such therapies to submit by October 20 applications either for a license or for an approval as an investigational new drug. National Cord Blood Program is the first to get FDA's nod, Scaradavou said.
"The use of cord blood hematopoietic (blood-forming) progenitor cell therapy offers potentially life-saving treatment options," said Dr. Karen Midthun, director of FDA's Center for Biologics Evaluation and Research, in a statement.
Hemacord comes with a boxed warning as it is associated with possibly fatal risks of Graft Versus Host Disease, engraftment syndrome, graft failure, and infusion reactions, the FDA said.
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