Clinical Research Studies

Patients with Ulcerative Colitis are often managed with corticosteroids, immunomodulators and monoclonal antibodies, all fraught with potential side effects. The advent of the biologic era for the treatment of moderate to severe Ulcerative Colitis was marked by the Federal Drug Administration (FDA) and European Medicine Agency’s (EMA) approval of infliximab, an anti-tumor necrosis-alpha (TNF) inhibitor, in 1998. Despite its known safety and efficacy, clinically significant rates of primary non-response and secondary non-response to anti-TNF agents has driven research to develop biologic therapies with alternative mechanisms of action.[1-7] Despite the number of monoclonal antibodies available, the rates of medically refractory disease requiring abdominal surgery has not significantly changed. As such, the need for alternative therapies with a safer profile and improved efficacy has become a priority. MSCs have recently demonstrated safety and improved efficacy for Ulcerative Coliti. However, cell-based therapy has logistical hurdles to successfully treat thousands of at need patients. Extracellular vesicles can overcome many cell-therapy logistical challenges related to shipping, thawing and shelf life.