Osteoarthritis stem cell trial approved
Tuesday, 20 January, 2009
Stem cell developer Mesoblast has received approval to begin a Phase II trial of its RepliCart knee cartilage product to slow or prevent the development of osteoarthritis after knee reconstruction.
The world-first trial will involve 24 patients between the ages of 18 and 40 who have had surgery to repair the anterior cruciate ligament in the last six months.
Patients will be randomised to receive either one of two doses of RepliCart injected into the knee joint together with hyaluronan, or hyaluronan alone. This glycan, also known as hyaluronic acid, is an important component of articular cartilage and is found in the extracellular matrix.
The trial’s primary endpoint will be safety of the stem cell therapy at 12 months, and its secondary endpoint prevention of cartilage loss and knee osteoarthritis during this period.
In earlier preclinical trials, a single injection of Mesoblast’s allogeneic stem cells into the knee joint shortly after knee surgery resulted in sustained and significant protection of joint cartilage and reduced the severity of knee osteoarthritis, the company said.
The trial’s lead investigator is orthopaedic surgeon Andrew Shimmin from the Melbourne Orthopaedic Research Foundation.
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