Mesoblast to Begin Stem Cell Study for the Prevention of Knee OA
BY LAUREN UZDIENSKI, JANUARY 23, 2009
Mesoblast announced this week that the company received Australian institutional ethics committee approval to begin a clinical study evaluating the use of its adult stem cell product, RepliCart, for the prevention of OA in patients who have had ACL repair. This will be the first human stem cell study for that indication.
The randomized, placebo-controlled, Phase 2 trial will enroll 24 patients between 18 and 40 years old who have undergone recent ACL reconstruction within six months of a traumatic knee injury. Patients will receive either one of two doses of RepliCart with hyaluronan or hyaluronan alone. The primary endpoint will be safety at 12 months, and the secondary endpoint is prevention of cartilage loss and knee OA at 12 months.
The company says that in prior preclinical studies, an injection of RepliCart resulted in "sustained and significant protection of joint cartilage and reduced the severity of knee osteoarthritis."
Mesoblast is developing additional orthopedic applications for its stem cell platform. Last August, the company reported promising results for its treatment for non-healing long bone fractures. In that study, eight of 10 patients achieved complete bony union, and a ninth patient, who had fractures of both the femur and tibia, achieved bony union of the tibia only. the study will eventually be used to support the company's U.S. IND application. Mesoblast has also named disc repair as a possible application for the technology.
