Normally, cord blood transplants are used for the treatment of patients suffering from blood cancers and certain inherited metabolic or immune system disorders. On this front, the U. S Food and Drug Administration (FDA) has approved the first licensed hematopoietic progenitor cells-cord (HPC-C) cell therapy to be used in stem cells transplantation procedures for patients.
HEMACORD comprises hematopoietic progenitor cells (HPCs) derived from human cord blood. As soon as these HPCs are introduced into the bodies of patients, the cells apparently transit to the bone marrow where they undergo division and growth. They turn mature and circulate in the blood that seems to resurrect the number and working of varied blood cells inclusive of immune function.
Karen Midthun, M.D., director, FDA’s Center for Biologics Evaluation and Research, cited, “The use of cord blood hematopoietic progenitor cell therapy offers potentially life-saving treatment options for patients with these types of disorders.”
HEMACORD gained the panel’s approval based on safety and effectiveness data provided to a public docket. Also, information regarding compliance and regulatory needs were demonstrated. This is supposedly the first time that a license application for cord blood has been approved.
The aforesaid cord blood treatment constitutes a boxed warning related to risks of Graft Versus Host Disease (GVHD), engraftment syndrome, graft failure, and infusion effects. These could also turn out to be lethal, therefore, patients on HEMACORD ought to be inspected minutely. A risk benefit assessment, unit selection and administration of the therapy should be implemented under the guidance of a physician who has experience in hematopoietic stem cell transplantation.
HEMACORD has been manufactured by the New York Blood Center.