About 30 million U.S. adults suffer from osteoarthritis (OA). Many of these patients put up with pain in the hopes of avoiding surgery, time recuperating and costs.
Patients suffering from knee OA have few options when it comes to pain management because there is no cure for the disease. Some turn to corticosteroid injections, which come with risks and can speed up progression of the disease, or hyaluronic acid injections, both of which only offer short-term relief by masking symptoms. Others eventually turn to total knee replacements which cost anywhere from $20,000 – $50,000 depending where in the U.S. a person lives, and require about 3.4 recovery days spent in the hospital following the procedure.
“Many of my patients who previously have had total knee replacement surgery didn’t fully understand what they were signing up for when they agreed to it,” says Dr. Gerard Malanga, founder of New Jersey Sports Medicine, LLC, and an invited expert at a recent collaborative industry roundtable discussion aimed at advancing cellular medicine. “If they had been aware of the risks, they would have loved to have had an alternative treatment and delay knee replacement surgery as long as possible.”
GID BIO’s single-use SVF-2 technology with point-of-care therapy harvests and isolates stromal vascular cells from a small sample of a patient’s adipose tissue to form an implant which is then reimplanted into the knee under ultrasound image guidance.
Endpoints in a multi-site, randomized, placebo-controlled Phase IIb clinical trial were met with 88% of participating patients responding greater than the placebo and reporting an 87% improvement in pain, stiffness and function at one year. At two years no serious or device-related adverse events were reported. With an FDA compliant pivotal study, the therapy could offer a potential treatment option for pain and function associated with knee OA.