FDA approves first umbilical-cord blood product
The FDA has given its first green light to a stem-cell transplantation product using umbilical-cord blood. Hemacord, produced by the New York Blood Center, is intended to treat patients with disorders affecting the blood-forming 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,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a prepared statement.
Cord blood is one of three sources of hematopoietic progenitor cell sources used in transplants. Once infused in patients, the cells migrate to the bone marrow and divide and mature, eventually moving into the bloodstream where they restore the number and function of many blood cells, according to the FDA.
Hemacord’s approval was based on safety and effectiveness data that was submitted by the Long Island, N.Y.-based blood center.
“The use of cord blood hematopoietic progenitor cell therapy offers potentially life-saving treatment options for patients with these types of disorders,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a prepared statement.
Cord blood is one of three sources of hematopoietic progenitor cell sources used in transplants. Once infused in patients, the cells migrate to the bone marrow and divide and mature, eventually moving into the bloodstream where they restore the number and function of many blood cells, according to the FDA.
Hemacord’s approval was based on safety and effectiveness data that was submitted by the Long Island, N.Y.-based blood center.