Jaime Garza, MD, DDS, FACS, Professor of Orthopaedics, Professor of Otolaryngology and Director of Human Regenerative Cell Trials at Tulane University School of Medicine, began enrolling patients, with the Tulane University Department of Orthopaedics, as principal investigator in an FDA-compliant pivotal/Phase III clinical trial testing our cellular therapy for knee osteoarthritis.
“I am very proud to collaborate with my alma mater, Tulane University, and the School of Medicine’s outstanding orthopaedic department led by Dr. Felix Savoie, and its world–class Center for Stem Cell Research and Regenerative Medicine,” said Dr. Garza.
Seventy-five percent of patients enrolled in the trial will receive our cellular therapy with the other 25% receiving a placebo injection. The procedure includes isolating a patient’s stromal cells from adipose (fat) tissue harvested by a physician under local anesthetic. Once the cells are concentrated into a cellular implant, they will be injected into the patient’s knee under image guidance for precise placement and characterization.
This trial follows the publishing of data in American Journal of Sports Medicine of a randomized, controlled, FDA-compliant Phase IIb clinical trial in which patients receiving our cellular therapy experienced an 89% improvement in pain, stiffness and function at one year compared to no improvement for those who received the placebo.
“The publication of this data signifies real science and a breakthrough in regenerative medicine,” said Dr. Garza. “Anyone treating osteoarthritis of the knee needs to prepare for the future by learning this procedure as a way to provide more options for patients.”
For more information about the clinical trial, visit: https://clinicaltrials.gov/ct2/show/NCT04440189.
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