Trial measures safety and efficacy of device and point-of-care therapy; first to meet endpoints for reducing pain and improving function in osteoarthritic knees
In a shift toward minimally-invasive treatments for orthopedics, an influx of misinformation about stem cells leaves patients vulnerable to treatments that haven’t been approved by the Food and Drug Administration (FDA) and that promote false promises and potentially risky outcomes.
American Journal of Sports Medicine (AJSM), a peer-reviewed, scientific journal, recently approved publication of results from a multi-site, randomized, placebo-controlled Phase IIb clinical trial testing the safety and efficacy of GID BIO’s SVF-2 device and cellular therapy in a paper titled, “Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A double blinded, prospective, randomized, controlled clinical trial.”
AJSM is the publication of the American Orthopaedic Society for Sports Medicine (AOSSM), a global organization with 3,000 members that generates evidence-based knowledge and promotes emerging research to educate orthopedic surgeons.
The randomized controlled Phase IIb clinical trial provided treatment to 39 patients randomized into three groups with 13 receiving placebo injections and the other two receiving either a low or high dose of the cellular implant. At one year, results showed that 88% of treated subjects responded greater than placebo and reported a median 87% improvement in pain, stiffness and function. At two years, no serious or device-related adverse events were reported. The FDA granted conditional approval for a larger pivotal study.
“One and two-year results of the randomized controlled Phase IIb clinical trial were statistically significant showing a potential major development in the treatment of pain and function associated with knee osteoarthritis,” said William W. Cimino, Ph.D., CEO of GID BIO.
In a time when 14 million U.S. adults are suffering from knee osteoarthritis and there is no cure nor FDA-approved minimally invasive treatment yet for consumers, engaging with the FDA to provide sound statistical data is a critical step in helping patients navigate healthcare decisions for safe and effective cellular medicine therapies.
“Scientifically proven cellular transplants using the patients’ own stromal cells, verified through FDA-approved clinical trials, are a breakthrough in regenerative medicine. The GID system utilizing the SVF-2 device should be the treatment of choice. Anyone treating osteoarthritis of the knee needs to prepare for the future by learning this procedure as a way to provide more options for patients. Delaying participation in the orthobiologics movement, similar to cardiothoracic surgeons 25 years ago not learning how to stent vessels to treat heart disease, can prevent orthopedic patients from benefitting from these new and proven therapies. Minimally invasive is now a standard,” said Jaime R. Garza, MD, DDS, FACS, principal investigator in the multi-site, randomized, placebo-controlled Phase IIb clinical trial and professor of orthopedic surgery, Center for Stem Cell Research and Regenerative Medicine at Tulane University School of Medicine.