This is a pivotal study. The study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device for pain, function and stiffness in the knees of osteoarthritic subjects.
Osteoarthritis is the main form of arthritis and affects over 20 million people in the United States. In the knee it can cause severe pain, reduced functionality and increased stiffness thus, a treatment that would reduce pain, increase function and reduce stiffness would be of benefit to many people. This study will collect and disassociate adipose tissue and inject the stromal vascular fraction into the knee of the same patient. The study is controlled, randomized and double-blinded with 2 SVF treatments (high and low dose) and a placebo control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
The GID SVF-2 device is a sterile single-use disposable canister used for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain associated with joint osteoarthritis.
Placebo Control
Cooper University Hospital
Camden, New Jersey, United States
Rothman Institute
Egg Harbor, New Jersey, United States
Texas Plastic Surgery
San Antonio, Texas, United States
Safety - Number of Participants With Treatment-Emergent Serious Adverse Events
Subjects will be monitored for serious and device related adverse events. Baseline MRIs will be compared to 1 year for any abnormal findings.
Time frame: up to 1 year
Efficacy - Percent Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 6 Months
The primary efficacy will be achieved if either dose group is shown to be superior to the placebo group at 6 months post-treatment, using the percent change in WOMAC score from baseline as the primary variable. The WOMAC score consists of 3 subscales, pain, stiffness and function. The overall score is normalized to a range of 0 to 100 points with a lower score indicating less symptoms of osteoarthritis.
Time frame: baseline and 6 months
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