Individuals who overuse their joints, such as athletes, military members and people working physically demanding jobs are at a high risk of developing knee osteoarthritis (OA), according to the Arthritis Foundation. Unfortunately, there is no cure on the market for the 14 million US adults suffering.
Industry experts say patients undergo more than 700,000 total knee replacement surgeries (TKR) annually, millions of hyaluronic and corticosteroid injections, and take millions of pain medications to manage the chronic condition.
GID BIO’s SVF-2 device and point-of-care cellular therapy aims to treat pain and function associated with knee osteoarthritis in a 120-minute outpatient procedure, which works by harvesting, isolating and reimplanting stromal progenitor cells into a patient’s knee under ultrasound guidance.
Here’s how the technology and therapy work:
- A physician extracts a small amount of fat tissue from the patient’s abdominal or gluteal region under local anesthetic.
- Using the SVF-2 technology, a patient’s own healing cells are harvested and isolated into a cellular implant.
- The cellular implant is injected into the knee under ultrasound image guidance for precise placement and characterization.
In a multi-site, randomized, placebo-controlled, Phase IIb clinical trial testing safety and efficacy, GID BIO’s SVF-2 device and therapy met all endpoints. Eighty-eight percent of treated subjects responded greater than placebo and reported a median 87% improvement in pain, stiffness and function after one year. After two years, no serious or device-related adverse events were reported. The FDA has granted conditional approval for a larger pivotal study.
“Our own progenitor cells know what to do and and in some cases do it better than medication when appropriately delivered into tissues. We call it healing intelligently,” said Dr. Ricardo J. Rodriguez, a plastic surgeon in Baltimore, Maryland. “Cells are like ‘intelligent agents’ that can detect what is going on in the tissue and respond in a targeted way. That can be significantly more potent than any other anti-inflammatory drug on the market. Because they modulate the inflammatory process through many pathways and stimulate a regenerative response they offer more benefit than any drug on the market can. This is one reason why GID BIO’s technology appears to be working given the Phase IIb results.”