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Shrock Clinical Research, the only approved site in Florida, joins GID BIO’s pivotal, FDA-compliant clinical trial for knee osteoarthritis

 

Kevin Shrock, MD, FAAOS, CPI, a South Florida practicing orthopaedic surgeon of 26 years and the 2023 president-elect for Florida Orthopaedic Society, is GID BIO’s newest principal investigator in a pivotal/Phase III clinical trial evaluating its cellular therapy for the treatment of pain and function associated with knee osteoarthritis. 

Shrock and his organization follow Tulane University School of Medicine, Texas Center for Cell Therapy and Research in San Antonio and New Jersey Regenerative Institute led by Jaime Garza, MD, DDS, FACS and Gerard Malanga, MD, respectively. 

“I am looking forward to joining this group of data-driven physicians in evaluating this cellular therapy for knee osteoarthritis,” says Shrock, former chairman of the American Academy of Orthopaedic Surgeons Board of Councilors Committee on Professionalism, a position in which he initiated efforts to create regenerative medicine standards. “GID BIO’s engagement with the FDA sets a standard for cellular therapy companies on how to comply with safety and efficacy guidelines too frequently overlooked in the regenerative medicine space.” 

Seventy-five percent of patients enrolled in the trial will receive GID’s cellular therapy with the other 25% receiving a placebo injection. Patients’ own cells will be harvested under local anesthesia, which will then be isolated into a stromal-vascular-fraction cellular implant and injected into the patient’s knee. 

This trial enters the osteoarthritis landscape at a time when patients’ treatment options are limited to pain management, including cortisone and hyaluronic acid injections, anti-inflammatory pills, physical therapy, and joint replacement surgery for end-stage disease.  

For more information about the clinical trial, visit clinicaltrials.gov

This cellular therapy is investigational, it is not approved by the FDA for sale or use in the U.S.

[1]Garza, J. R., R. E. Campbell, F. P. Tjoumakaris, K. B. Freedman, L. S. Miller, D. Santa Maria and B. S. Tucker, 2020: Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. The American Journal of Sports Medicine, 48, 588-598


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