A randomized controlled Phase IIb clinical trial approved by the Food and Drug Administration (FDA) measuring safety and efficacy of our single-use SVF-2 device and point-of-care (POC) therapy intended to improve function and reduce pain associated with knee osteoarthritis (OA) met all endpoints at one year. Eighty-eight percent of subjects responded greater than placebo and reported a median 87 percent improvement in pain, stiffness and function. At two years, no serious or device-related adverse events occurred.
Knee OA affects 14 million US adults and is a factor in more than 700,000 total-knee replacements annually with no minimally invasive option available. Total knee replacement surgery has complications:
- 12% of patients become addicted to painkillers
- 20% work fewer hours one year after surgery
- 40% have chronic pain one year after surgery
With a cellular therapy approach, patients receive a small injection of a cellular implant made with their own cells in a 120-minute procedure.
Patients “are reassured when they hear the therapy uses their cells and not someone else’s cells,” said Dr. Daniel L. Santa Maria, a sports medicine physician in San Antonio, Texas. “[With a cellular implant and short recovery time they] can return quickly to life goals.”
GID’s SVF-2 device and POC cellular therapy represents a potential shift in knee pain treatment, mirroring what cardiovascular surgeons saw with minimally invasive stents 25 years ago. Amidst the noise of unproven cellular therapies, statistically significant two-year data provides information patients and providers need to make informed decisions.