Pilot Safety Study of an Extracellular Vesicle Isolate Product for Treatment of Osteoarthritis in Combat-Related Injuries: One Year Follow Up

Abstract

Objective: This is the first report on the safety and clinical efficacy of a bone marrow mesenchymal cell extracellular vesicle isolate product (XoFloTM) to treat osteoarthritis (OA). Design, Setting, and Methods: Thirty-three Navy SEAL veterans were treated with XoFlo for OA of the knee (n=58), shoulder (n=32), elbow (n=16), hip (n=12), ankle (n=8) or wrist (n=6). Four Pain and Motion Indexes were used to evaluate patients’ OA. Results: At 1-year follow-up, the average patient improved 82% in BPI, 77% in ODI, 67% in LEFS, 50% in UEFS, and 77% in QD. All improvements were statistically significant with values of p<0.001. Ninety-five percent of the improvement occurred within the first six weeks following the injection and continued through the 1-year follow-up. There were no complications or adverse events, minor or major. No patient was observed to have accelerated OA progression or made clinically worse from the XoFlo injection. Conclusions: At 1-year follow-up, a 2cc injection per joint of XoFlo appears to be safe and clinically efficacious for the treatment of patients with at least Grade 2 changes of OA utilizing the Kellgren-Lawrence scale. These patients will continue to be followed for at least two years.