GID BIO reaches halfway enrollment in cell therapy trial

GID BIO reaches halfway enrollment in randomized double-blinded pivotal Phase III cell therapy trial

GID BIO reaches halfway enrollment in randomized double-blinded pivotal Phase III cell therapy trial

FDA-compliant trial addresses treatment gap for regenerative medicine to potentially treat knee osteoarthritis

April 5, 2023 – Louisville, Colo. GID BIO, Inc., reached its halfway enrollment point at nine U.S. trial sites in a pivotal Phase III trial to potentially treat knee osteoarthritis (OA) using one’s own stromal vascular fraction cells.  GIDOA-03 is one of the first FDA-compliant, multi-site, double-blinded, randomized, placebo-controlled ongoing trials studying this disease state.

Trial end points consist of evaluating pain, stiffness, function and mobility, which are symptoms and causes of knee OA. This trial investigates the use of autologous, adipose-derived SVF cells to potentially improve symptoms. 

The CDC reports osteoarthritis is the most common form of arthritis with 32.5 million US adults suffering from it. Osteoarthritis of the knee cannot be stopped or reversed describes Arthritis.org. A huge need today is filling a treatment gap to potentially reduce pain, stiffness and function in knee OA. Symptom management limits patients to over-the-counter medications, prescription drugs and injections like hyaluronic acid or corticosteroids. A last resort of irreversible surgery means a total knee replacement.

Trial sites for pivotal Phase III enrollment include: New Jersey Regenerative Institute, University of Texas, San Antonio, Texas Center for Cell Therapy and Research at the Texas Center for Athletes, Tulane University School of Medicine, University of California, Davis, OrthoCarolina, Ohio State University Wexner Medical Center, Wake Forest Institute for Regenerative Medicine, University of Pittsburgh Medical Center, Ascension Medical Group and Advanced Research Florida managed by primary investigators, Jay Bowen, D.O., Jaime Garza, M.D., D.D.S., F.A.C.S., Charles DeMesa, D.O.,  T. Moorman M.D., Michael Baria, M.D., Neil Sparks, D.O., M.S., Kentaro Onishi, D.O., Peter Rubin, M.D., Tariq Awan, D.O., and Manish Gupta, M.D., respectively.

Sandeep Samudre, Ph.D., M.P.H., Director of Clinical Affairs at GID BIO, Inc. said, “GID BIO has reached a milestone in our pivotal Phase III trial. In this late phase, sponsors can be challenged to demonstrate consistent results from earlier phases of the trial. Independent trial sites stand ready to achieve full enrollment in this promising trial to develop a safe, practical and effective cellular therapy that’s available at point-of-care to treat patients with some of the most disabling chronic diseases.”

The American Academy of Orthopaedic Surgeons, the world’s largest musculoskeletal specialist association, continues to explore minimally invasive treatments to advance traditional pain management solutions beyond surgery. In 2019, it announced an investment in orthobiologics.

About GID BIO, Inc.

GID BIO is a regenerative medicine company that delivers evidence-based outcomes using a patient’s own autologous, adipose-derived stromal vascular fraction cells to potentially transform degeneration into regeneration so the body can heal intelligently. GID BIO SVF therapeutic applications currently advancing in clinical development include musculoskeletal, soft tissue and organ chronic conditions. Information about GID BIO SVF cell therapy can be found at: https://www.GIDBIO.com

Contact: Kellee Johnson, 312-751-3959, kjohnson@ballastgroup.com

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