Title: Use of GID SVF-2 Device to Produce Autologous Adipose-Derived Stromal Vascular Fraction for Treatment of Osteoarthritis of the Knee: A Pivotal Medical Device Randomized Concurrent Controlled Study
PI: J. Peter Rubin, MD
Description: This study is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.
Osteoarthritis affects over 30 million people in the United States and is the most common cause of disability. In the knee it can cause severe pain and increased stiffness, leading to reduced functionality and disability.
Primary & Secondary Objectives: Primary Objective: To evaluate the efficacy, using measures of pain and function, of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.
Secondary Objective: To evaluate the safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.
Measurement/Outcomes: The composite endpoint requires that each knee achieve pre-specified improvements in the WOMAC pain score and the WOMAC function score to achieve a success. The threshold for clinically important improvement for WOMAC pain is larger (≥ 55%, CII WOMAC Pain) because the primary indication for treatment is to reduce knee pain. In order for a knee to be considered a clinical success, the improvement in pain must have a concomitant minimum clinically important improvement in function (20%, MCII WOMAC Function).
The primary effectiveness evaluation is to test superiority of the active treatment relative to placebo using methods for comparing proportions between two groups. Primary efficacy endpoint is six months post treatment. Final endpoint for the study is 12 months.
Secondary Endpoint: Evaluation of Safety. Device, treatment and procedure related adverse event rates and severity will be summarized.
Numbers of subjects to undergo intervention At the University of Pittsburgh: 10