First Cord-Blood Transplant Therapy Approved by FDA

November 10, 2011

November 10, 2011 — The US Food and Drug Administration (FDA) today approved the first cord-blood product — called Hemacord — for stem-cell transplants that replenish blood cells of patients with certain blood cancers and inherited metabolic and immune system disorders.

The product, made by the New York Blood Center, contains hematopoietic progenitor cells (HPCs) drawn from the blood remaining in a newborn's umbilical cord as well as the placenta after childbirth. Also called hematopoietic stem cells, HPCs in the bloodstream morph into red blood cells, white blood cells, platelets, and other types of cells. HPCs can also be derived from bone marrow and peripheral blood.

Hemacord is indicated for hematopoietic stem-cell transplantation in patients with disorders that affect their ability to make blood. Once infused into a patient, HPCs migrate to bone marrow, divide and mature, and then migrate to the bloodstream, where they "can partially or fully restore the number and function of many blood cells, including immune function," the FDA stated in a press release.

A boxed warning on the product's label lists the risks for infusion reactions, graft failures, engraftment syndrome, and graft-versus-host disease, all potentially fatal. The FDA advises clinicians to carefully monitor patients receiving Hemacord.

More information on today's announcement is available on the agency's Web site.

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