FDA approved the first cord blood product for stem cell transplantation
Last reviewed: 23.04.2024
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The product, known as Hemacord, is intended for use during the transplantation of hematopoietic stem cells in patients with diseases of the hematopoietic (hematopoietic) system, namely: certain types of blood cancer, hereditary metabolic disorders and the immune system.
"The use of cord blood in hematopoietic stem cell transplant procedures can save the lives of many patients with these diseases," said Dr. Karen Midtun, director of the FDA Center.
Hemacord contains hematopoietic progenitor cells from human cord blood. A study published last year showed that the use of cord blood in the treatment of acute leukemia in adults is effective.
In 2009, the agency issued official guidance to help manufacturers in obtaining licenses for cord blood products. Within this framework, the FDA for 2 years analyzed data from manufacturers and new studies on the use of the drug.
Hemacord's approval was based on safety and efficacy data confirmed by clinical trials.
The product will contain an instruction in which there will be a warning about the risks of the "graft versus host" reaction, transplant rejection reactions and other effects that may even lead to death, the agency said.
"Patients who receive Hemacord should be carefully monitored by a doctor who has the experience of transplanting hematopoietic stem cells with a risk / benefit assessment," the FDA noted.
Hemacord is produced by New Blood-York Center, which is located in New York.
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