One month safety study of ExoFlo injection for the treatment of lumbar or cervical radiculopathy in the epidural space

Abstract

This One month safety study addresses any potential risks behind the use of bone marrow-derived mesenchymal stem cell extracellular vesicle isolate product (ExoFlo Direct Biologics) as a treatment for cervical and lumbar radiculopathy. Ten healthy adults were treated with ExoFlo injections for cervical radiculopathy (n=5) and lumbar radiculopathy (n=5). Follow up occurred twenty-four hours, three days, one week, three weeks and one month post injection. By the one month follow-up, the average patient improved 55% in BPI, 55.2% in QD, 25.4% in UEFS, 19.75% in ODI and 26% in LEFS. There were no complications or adverse events by the end of the study and no patient exhibited worsening radiculopathy. Patients will continue to be followed for at least six months post injection.