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.

The patient is a 51 years old athlete with a 2 ½ yr. history of increasing left medial and patella-femoral knee pain. He had previously failed two arthroscopic procedures, a hyaluronic acid and PRP injections. MRI and arthroscopy indicated Kellgren-Lawrence grade three arthritis in the medial femoraltibial and patellofemoral areas of the knee joint. He underwent a single injection of bone marrow-derived mesenchymal stem cell EVIP (ExoFlo Direct Biologics, St. Louis MO) containing active growth factors (over 800) and exosomes (0ver 10 Billion per cc). Within two weeks he had returned to normal activities. At six-month follow-up he feels his overall improvement is 75%. His improvement at six-month follow-up in BPI was 96%, ODI 84% and LEFS 59%. There were no complications with the injection.