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New stem cell product for unrelated donor-recipient transplants gets FDA go-ahead

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DUCORD, derived from umbilical cord blood, has been approved for use in patients with disorders affecting the hematopoietic system — which produces the body’s blood cells —that are inherited, acquired or result from radiation treatment or chemotherapy.

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.

“This approval and the quality it reinforces are lynchpins in Duke Medicine’s commitment to developing and translating innovative cellular therapies,” said Victor J. Dzau, M.D., chancellor for health affairs at Duke University and president and CEO of Duke University Health System.

Blood from babies’ umbilical cords, which was once discarded, is rich in hematopoietic stem cells. These stem cells are able to renew themselves and differentiate into specialized cells. When transplanted in people with lymphoma, leukemia, immune disorders and genetic conditions, they can establish a life-saving new blood and immune system.

Joanne Kurtzberg, M.D., directs Duke’s Pediatric Blood and Marrow Transplant Program and serves on the editorial board of STEM CELLS Translational Medicine. Under her direction, the program has performed more than 2,000 transplants in children with cancer or genetic diseases since 1990. She also helped found the public bank through CCBB and pioneered the treatment of patients with cord blood from unrelated donors, performing the world’s first unrelated cord blood transplant for a child with leukemia in 1993.

Since opening in 1998 as part of the Cord Blood Transplantation (COBLT) Study, the CCBB has banked more than 25,000 racially and ethnically diverse, high quality cord blood units. Prior to receiving the FDA license, CCBB provided more than 1,500 cord blood units throughout the world under an IND application.

“Licensure enables the CCBB to continue to provide cord blood units to patients in need of a donor for unrelated transplantation,” Dr. Kurtzberg said.

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Duke University School of Medicine