FDA Okays First Cord Blood Product
The agency approved Hemacord for use in stem-cell transplants.
The product, known as Hemacord, "is indicated for use in hematopoietic stem cell transplantation procedures in patients with disorders affecting the hematopoietic (blood-forming) system," the agency said in a statement.
That includes certain blood cancers as well as some inherited metabolic and immune system disorders.
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"The use of cord blood hematopoietic progenitor cell therapy offers potentially life-saving treatment options for patients with these types of disorders," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the statement.
Hemacord contains hematopoietic progenitor cells from human cord blood. A study published last year found that cord blood was comparable to bone marrow or peripheral blood progenitor cells in treating acute leukemia in adults, with similar effects on leukemia-free survival.
In 2009, the agency issued a guidance document to help cord blood manufacturers who wanted to license their products. As part of that effort, the FDA implemented a two-year phase-in period for manufacturers to submit either a license application or an investigational new drug application. That period ended on Oct. 20.
Hemacord's approval was based on safety and effectiveness data submitted by the company, although the statement did not provide further specifics.
The product will carry a boxed warning about the risks of graft-versus-host disease, engraftment syndrome, graft failure, and infusion reactions, each of which may be fatal, the agency said.
Patients who receive Hemacord should be monitored carefully, with a risk/benefit assessment and administration performed "under the direction of a physician experienced in hematopoietic stem cell transplantation," the FDA noted.
Hemacord is manufactured by the New York Blood Center, based in New York City.