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30-a few Navy SEAL veterans have been treated with a bone marrow mesenchymal mobile (MSC) derived extracellular vesical isolate products (EVIP) for Osteoarthritis (OA) of the knee, shoulder, elbow, hip, ankle, or wrist.
Direct Biologics LLC.
Direct Biologics LLC.
AUSTIN, Texas, Nov. 11, 2021 (World NEWSWIRE) — Direct Biologics, LLC, a sector-major biotech organization in the field of regenerative biologics, announced the publication of the just one-year observe-up effects from a pilot safety analyze of a MSC-derived EVIP for therapy of OA in overcome-similar accidents in the Journal of Stem Mobile Analysis.
This publication follows the to start with report on the basic safety and clinical efficacy of human MSC-derived EVIP ExoFlo to deal with OA (East DO J, Alexander DC T, Dordevic M. (2020) IRB Accredited Pilot Basic safety Review of an Extracellular Vesicle Isolate Merchandise Assessing the Therapy of Osteoarthritis in Fight-Related Accidents. 1(2):1-10). In an impartial, IRB-accepted pilot research done in 2020 by Dr. Johnny East, ExoFlo was utilized to handle 33 Navy SEAL veterans for beat-linked OA. Individuals been given a one injection of 2mL of ExoFlo into just about every taken care of joint. 6 months after currently being injected with ExoFlo, the typical affected person professional considerable advancements in both of those discomfort and functionality.
At the a single-12 months observe-up, the regular client enhanced 82% in Temporary Agony Inventory (BPI), 77% in Ostwestry Incapacity Index (ODI), 67% in Lower Extremity Purposeful Scale (LEFS), 50% in Higher Extremity Practical Scale (UEFS), and 77% in QuickDash Scale (QD). All enhancements had been strongly statistically major with p price < 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.
About ExoFlo
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.
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Mike Albanese
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