AUSTIN, Texas, November 11, 2021 (Newswire.com) - Direct Biologics, LLC, a market-leading biotech company in the field of regenerative biologics, announced the publication of the one-year follow-up results from a pilot safety study of a MSC-derived EVIP for treatment of OA in combat-related injuries in the Journal of Stem Cell Research.
This publication follows the first report on the safety and clinical efficacy of human MSC-derived EVIP ExoFlo to treat OA (East DO J, Alexander DC T, Dordevic M. (2020) IRB Approved Pilot Safety Study of an Extracellular Vesicle Isolate Product Evaluating the Treatment of Osteoarthritis in Combat-Related Injuries. 1(2):1-10). In an independent, IRB-approved pilot study completed in 2020 by Dr. Johnny East, ExoFlo was used to treat 33 Navy SEAL veterans for combat-related OA. Patients received a single injection of 2mL of ExoFlo into each treated joint. Six months after being injected with ExoFlo, the average patient experienced significant improvements in both pain and function.
At the one-year follow-up, the average patient improved 82% in Brief Pain Inventory (BPI), 77% in Ostwestry Disability Index (ODI), 67% in Lower Extremity Functional Scale (LEFS), 50% in Upper Extremity Functional Scale (UEFS), and 77% in QuickDash Scale (QD). All improvements were strongly statistically significant with p value < 0.001. Ninety-five percent of the improvement occurred within the first six weeks following the injection and continued through the one-year follow-up. No complications or side effects were reported, and no patient was worse after the injection.
Mesenchymal stromal/stem cells (MSCs) are believed by scientists to help healing by generating the release of extracellular vesicles (EVs). EVs are key players in cell-to-cell communication and natural healing with potential long-term benefits. The mainstay treatment for OA, steroids, is effective only for one to two months with many long-term side effects—in searching for healthier alternatives, Dr. East chose to investigate ExoFlo as he thought it could not only be beneficial for patients with musculoskeletal and spine issues, but also for OA.
Osteoarthritis is the most common chronic disease in the US, affecting up to 55 million people and current treatment options are limited. Patients with OA experience pain and loss of motion limiting or impairing certain activities of daily living. There is a substantial gap in care for non-operative and operative options for patients suffering pain and impairments from OA.
ExoFlo is an investigational new drug that has not been approved or licensed by FDA. It is an extracellular vesicle based biologic product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.
About Direct Biologics, LLC
Direct Biologics is headquartered in Austin, Texas, with an R&D facility located at the University of California, and an operations and order fulfillment center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of EV-based biological products. The company was created to expand the science of cutting-edge biologic technologies. Direct Biologics' management team holds extensive collective experience in biologics research, development, and commercialization, making the company a leader in the evolving, next-generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of its EV products through the Food and Drug Administration's investigational new drug application process. For more information, visit http://www.directbiologics.com.
Source: Direct Biologics