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:
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.
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