GID BIO completed a pivotal Phase IIb clinical trial with an FDA-approved study design using autologous stromal cells in the treatment of knee osteoarthritis (OA), successfully meeting endpoints and two-year safety results.
The trial demonstrated a median 87% reduction in pain, stiffness and function with no serious or device-related adverse events; 88% of subjects responded greater than placebo at one year.
The data supports a second pivotal Phase III trial for the company's SVF-2 technology (stromal vascular fraction) and point-of-care therapy.
GID technology has essentially reduced a Good Manufacturing Practices cell-processing facility to a single disposable device for scalable point-of-care cell processing, as shown below. The technology isolates, concentrates and extracts harvested stromal cells from a patient’s adipose tissue. The cellular implant is then injected under ultrasound guidance in a physician’s office. The American Medical Association granted GID two new CPT class III codes that will become effective January 2020.
In orthopedics, the company's technology could have application in the treatment of hip and small joint OA, anterior cruciate ligament and tendon repair, etc.