FDA approves DUCORD product for stem cell transplants

October 9, 2012

Duke University School of Medicine has received approval from the Food and Drug Administration to market DUCORD, a stem cell product derived from umbilical cord blood, for use in transplants between unrelated donors and recipients.

DUCORD is approved for use in hematopoietic for patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

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 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.

"This is a major milestone in the history of the university and a significant step forward in the field of regenerative medicine at Duke and elsewhere," said Nancy Andrews, M.D., dean of the Duke University School of Medicine

, 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.

Blood from babies' umbilical cords, which was once discarded, is rich in hematopoietic stem cells. Joanne Kurtzberg, M.D., director of Duke's 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.

"The licensure of DUCORD is a reflection of the dedication and hard work of the entire CCBB staff over the past decade," said Kurtzberg, medical director and founder of the CCBB. "Licensure enables the CCBB to continue to provide cord blood units to patients in need of a donor for unrelated transplantation. We feel that going through the licensure process has strengthened and improved our operations. In addition, it will allow the CCBB to provide the highest quality cord blood units as source material for new clinical applications in cellular therapies in the future."

To receive the FDA license, the CCBB submitted an application documenting the steps, policies and procedures required for manufacturing high quality cord blood units, including collection, processing, testing, storing and distributing the cells.

"FDA approval is a major statement about the quality of the product and the methods used to produce it," said Robert Califf, M.D., Duke's vice chancellor for clinical research.

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.

The CCBB is also a member of the National Cord Blood Inventory of the C.W. Bill Young Cell Transplantation Program, administered through the U.S. Department of Health and Human Services.

Kurtzberg said the CCBB staff is committed to advancing the benefits of stem cells isolated from umbilical cord blood, and to improve the lives of those inflicted with inherited and acquired serious and life-threatening medical conditions.  

"Dr. Kurtzberg's program has successfully balanced the urgent pressure to innovate and find new cures for our patients with the painstaking care that prioritizes patient safety and permits rigorous regulatory review," Dzau said.

Explore further: Researchers say therapy improves stem cell engraftment in umbilical cord blood transplant recipients

Related Stories

Researchers say therapy improves stem cell engraftment in umbilical cord blood transplant recipients

December 12, 2011
A therapy involving a natural compound may improve the ability of stem cells from umbilical cord blood to engraft in patients receiving a stem cell transplant for cancer or other diseases, a phase I clinical trial led by ...

Enhanced cord blood stem cell transplants safe in long-term studies

April 18, 2011
(Medical Xpress) -- An innovative experimental treatment for boosting the effectiveness of stem-cell transplants with umbilical cord blood has a favorable safety profile in long-term animal studies, report scientists from ...

Recommended for you

Want to win at sports? Take a cue from these mighty mice

July 20, 2017
As student athletes hit training fields this summer to gain the competitive edge, a new study shows how the experiences of a tiny mouse can put them on the path to winning.

'Smart' robot technology could give stroke rehab a boost

July 19, 2017
Scientists say they have developed a "smart" robotic harness that might make it easier for people to learn to walk again after a stroke or spinal cord injury.

Engineered liver tissue expands after transplant

July 19, 2017
Many diseases, including cirrhosis and hepatitis, can lead to liver failure. More than 17,000 Americans suffering from these diseases are now waiting for liver transplants, but significantly fewer livers are available.

Lunatic Fringe gene plays key role in the renewable brain

July 19, 2017
The discovery that the brain can generate new cells - about 700 new neurons each day - has triggered investigations to uncover how this process is regulated. Researchers at Baylor College of Medicine and Jan and Dan Duncan ...

New animal models for hepatitis C could pave the way for a vaccine

July 19, 2017
They say that an ounce of prevention is worth a pound of cure. In the case of hepatitis C—a disease that affects nearly 71 million people worldwide, causing cirrhosis and liver cancer if left untreated—it might be worth ...

Omega-3 fatty acids fight inflammation via cannabinoids

July 18, 2017
Chemical compounds called cannabinoids are found in marijuana and also are produced naturally in the body from omega-3 fatty acids. A well-known cannabinoid in marijuana, tetrahydrocannabinol, is responsible for some of its ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.