Mesoblast, Melbourne, Australia, announced that it has received Australia's first institutional ethics-committee approval for a human trial evaluating the use of an adult stem-cell product to prevent knee osteoarthritis (OA) in patients who have had surgery to repair a damaged anterior cruciate ligament (ACL). The company will use its own proprietary stem-cell product, RepliCart, on 12 patients, compared to a matched placebo-controlled group of 12.
The enrolled participants will be between 18 and 40 years old and will have undergone ACL reconstruction within six months of a traumatic knee injury. Participants will receive doses of either RepliCart with hyaluron or hyaluron alone. The trial's primary endpoint will be safety of the stem-cell therapy at 12 months, and the secondary endpoint will be prevention of cartilage loss and knee OA at 12 months.
"ACL injury is very common in our young, active, sporting population, and unfortunately the injury is associated with the early development of arthritis despite modern reconstructive procedures," said Andrew Shimmin, MD, the trial's lead investigator. "Little has changed in the prevention and treatment of arthritis over the past 50 years, so the application of Mesoblast's stem-cell technology for reducing the progression of this degenerative process in the knee offers a new and exciting direction for the management of arthritis."
Mesoblast's website says, "In earlier preclinical trials, a single injection of [RepliCart] into the knee joint shortly after knee surgery resulted in sustained and significant protection of joint cartilage and reduced the severity of knee arthritis."
In August 2008, Mesoblast reported successfully using its stem-cell technology to treat non-healing long-bone fractures. In that pilot study, nine of ten participants experienced complete bony union of at least one fractured long bone within a median time of four months. The participants had had a non-united fracture for as many as 41 months prior to cell implantation.
