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Patient enrollment is open for a pivotal/Phase III clinical trial to test GID BIO’s cellular therapy for knee osteoarthritis

 

GID BIO’s point-of-care cellular therapy is being tested to treat knee osteoarthritis in an FDA-compliant pivotal/Phase III clinical trial being led by:

Patients are randomly assigned in this controlled and blinded clinical trial and receive either the cellular therapy injection (75% of patients) or a placebo injection (25% of patients). The patient and physician do not know which treatment the patient receives. Participants in the clinical trial undergo an out-patient treatment where:

  • a physician harvests a small amount of fat tissue from a patient’s abdominal or gluteal region under local anesthetic
  • the participant’s own stromal cells are isolated and concentrated into a cellular implant using GID’s SVF-2 technology platform 
  • depending on randomization, the patient receives either the cellular therapy or placebo injected into his or her knee under image guidance for precise placement and characterization.

Trial data published in the American Journal of Sports Medicine from our Phase IIb clinical trial demonstrates that patients receiving the cellular therapy experienced an 89% improvement in pain, stiffness and function at one year compared to no improvement for those who received the placebo [1].

The free study is looking to enroll healthy men and women 35- to 85- years old with knee inflammation and a body mass index of 22 to 37. 

Contact one of the trial sites for eligibility to enroll or to refer a potential patient. Visit clinicaltrials.gov for more information.

  • Tulane University
  • New Orleans, Louisiana, United States, 70112
  • Contact: Emily Callegari, 504-988-0200, ctu@tulane.edu

 

  • Texas Center for Cell Therapy and Research
  • San Antonio, Texas, United States, 78240
  • Contact: Jennifer Krieger, 210-616-0301, jkrieger@txps.net

 

  • New Jersey Regenerative Institute
  • Cedar Knolls, New Jersey, United States, 07927
  • Contact: Shalaka Paranjpe, 973-998-8301, sparanjpe@kesslerfoundation.org

 

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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