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Duke University School of Medicine has received approval from the Food and Drug Administration to market stem cell product, called DUCORD for use in hematopoietic stem cell transplantation for patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
Hematopoietic stem cells, derived from cord blood and produced in the bone marrow, are able to renew themselves and differentiate into specialized cells. When transplanted in people with lymphoma, leukemia, immune disorders and genetic conditions, these robust cells can establish a life-saving new blood and immune system.
The approval marks a significant achievement for Duke and the Carolinas Cord Blood Bank (CCBB), a not-for-profit, public cord blood bank at the medical school, which has pioneered cord blood transplants for children and adults with cancer, blood disorders and inherited diseases. Only two other cord blood banks in the United States have received FDA approval to market similar stem cell products.
Blood from babies’ umbilical cords, which was once discarded, is rich in hematopoietic stem cells. Joanne Kurtzberg, M.D., director of Duke’s Pediatric Blood and Marrow Transplant Program, was a trailblazer in their use for transplants and was a founder of the public bank through CCBB. Kurtzberg has remained at the forefront of expanding the use of cord blood for patients with life-threatening diseases.
Prior to receiving the FDA license, CCBB provided more than 1,500 high quality cord blood units throughout the world under an FDA Investigative New Drug application. Currently, all CCBB units are listed on the National Bone Marrow and Donor Program’s “Be the Match” registry, a central database for transplant centers to search and request cord blood units for patients in need of unrelated donors for transplantation.
Reference: http://www.dukehealth.org
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