Sentara Leigh Hospital One of Four U.S. Sites in FDA Clinical Trial on Neocartilage
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Sentara Leigh Hospital One of Four U.S. Sites in FDA Clinical Trial on Neocartilage 

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Norfolk, VA - January 15, 2007 – Beginning in January, orthopedic surgeons at Sentara Leigh Hospital will be participating in a Phase I clinical trial of Neocartilage—a living tissue graft designed to repair cartilage defects, restore joint function and relieve pain in the knee. Sentara Leigh Hospital is one of four sites in the country participating in the clinical trial.

The trial is designed to study the safety of Neocartilage—living tissue grown from donor juvenile cartilage cells. The resulting implant is a thin, solid disk about the size of a quarter that resembles natural articular cartilage.

“This procedure is not for people suffering from terrible arthritis,” said Dr. Kevin F. Bonner, orthopedic surgeon with the Jordan-Young Institute and principal investigator of the study at Sentara Leigh Hospital. “It’s for younger people with a focal cartilage defect in the knee which has not yet progressed into diffuse arthritis. The goal is to decrease pain, improve function and to potentially prevent or postpone the need for knee replacement.”

Building on past clinical research in the field of regenerating cartilage, this new technology harvests young chondrocytes (cartilage cells), which are placed into a nutrient-medium. Over time, the cells produce the thin solid disk, which is surgically implanted into the knee joint to replace the damaged cartilage.

“One single juvenile donor has the potential to create hundreds of grafts,” Bonner said. “Juvenile cartilage cells have far greater growth capacity and healing capacity than their adult counterparts.”

It is hoped that this regenerated cartilage will reduce the need for cartilage transplants. Patients have to wait on cartilage transplant lists, in some cases, over a year before receiving donor cartilage.

Study participants must be between 18 and 55 years old, with moderate to severe knee pain. “If successful, the grafts will regenerate a more natural cartilage than other current cell based regeneration options. This will potentially provide a new option for patients with damaged knee cartilage,” Bonner said. It is expected that complete rehabilitation will take 18 months in four phases. Success of the cartilage regeneration will be monitored with MRI (magnetic resonance imaging).

Other sites participating in the trial are: Rush Presbyterian Hospital, Chicago; Brigham and Women’s Hospital, Boston; and the Cartilage Restoration Center of Indiana, Indianapolis.

If you think you may be a candidate for the neocartilage study, discuss it first with your orthopedic surgeon who can review your situation to help determine if this procedure is right for you. Additional information on the Sentara Leigh Hospital study is available through Dr. Bonner’s study coordinator at 502-8586.



2/2007

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