FDA approves first cord blood product
The FDA has approved the first ever umbilical cord blood product for use in stem-cell transplants.
Hemacord is indicated for use in hematopoietic stem cell transplants in patients with disorders affecting the hematopoietic system, such as certain blood cancers, and inherited metabolic and immune system disorders.
“The use of cord blood hematopoietic progenitor cell therapy offers potentially life-saving treatment options for patients with these types of disorders,” Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, said in a press release.
Hemacord contains hematopoietic progenitor cells from human cord blood. In 2009, the FDA issued a guidance document for cord blood manufacturer's who wanted to license their product and instituted a two-year phase-in period those who wished to submit either a license application or an investigational new drug application. That period ended Oct. 20, 2011.
Hemacord received approval based on safety and effectiveness data, according to the FDA. The product will contain a boxed warning regarding potentially fatal risks, including Graft Versus Host Disease (GVHD), engraftment syndrome, graft failure and infusion reactions.
Careful patient monitoring and risk benefit assessment are necessary for all patients receiving Hemacord, the agency emphasized. Hemacord should only be selected and administered under direction from a physician experienced in hematopoietic stem cell transplantation.