IRB Approved Pilot Safety Study Of An Extracellular Vesicle Isolate Product Evaluating The Treatment Of Osteoarthritis In Combat-Related Injuries
Johnny East, Trace Alexander, Maxwell Dordevic
Abstract
Secreted bone marrow mesenchymal stem cell derived extracellular vesicles (BM-MSC-EVs) are reported to contain hundreds of different growth factors, cytokines, chemokines, micro and messenger RNAs packaged within exosomes. This is the first report on the safety and clinical efficacy of an BM-MSC-EV product (ExoFlo) to treat osteoarthritis (OA). Thirty-three Navy SEAL veterans were treated with ExoFlo for OA of the knee (n=58), shoulder (n=32), elbow (n=16), hip (n=12), ankle (n=8) or wrist (n=6). At six-month follow-up, the average patient improved 77% in BPI, 80% in ODI, 76% in LEFS, 51% 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 injection. There were no complications or adverse events, minor or major, and no patient was observed to have accelerated OA progression resultant from the ExoFlo injection. These patients will continue to be followed for at least 2-years. At six-month follow-up, a single ExoFlo injection for OA appears safe and clinically efficacious for the treatment of patients with at least grade-2 changes utilizing the Kellgren-Lawrence scale.