This summer, the FDA cleared our stromal-vascular-fraction cellular therapy for a pivotal/Phase III clinical trial to test its safety and efficacy in the treatment of knee osteoarthritis. Three initial sites were secured and announced in Denver Business Journal: Tulane University School of Medicine, Texas Center for Cell Therapy and Research in San Antonio, and New Jersey Regenerative Institute in Cedar Knolls.
Texas Center for Cell Therapy and Research is now enrolling patients under the direction of principal investigator, Dr. Jaime Garza, MD, DDS, FACS, Professor of Surgery at University of Texas Health Science Center at San Antonio.
Dr. Garza, a physician with 10 years of experience leading FDA-compliant clinical trials, is eager to begin screening patients with grade II – IV knee osteoarthritis for trial eligibility. As a principal investigator in our multi-site, randomized, placebo-controlled Phase IIb clinical trial, which concluded in 2017, Dr. Garza has seen first-hand patient results of our therapy.
“The Phase IIb results signified real science and a breakthrough in regenerative medicine,” said Dr. Garza. “GID BIO’s technology platform should be [if approved] the treatment system of choice.”
Patients deemed eligible for the trial will undergo an out-patient treatment performed in under two hours, where:
- A physician harvests a small amount of fat tissue from the patient’s abdominal or gluteal region under local anesthetic.
- The patient’s own cells are isolated and concentrated using our technology, into a cellular implant.
- The cellular implant is injected into the knee under image guidance for precise placement and characterization.
More information is available at clinicaltrials.gov.