New Jersey Regenerative Institute begins enrolling patients for GID BIO’s pivotal/Phase III clinical trial testing cellular therapy for knee osteoarthritis
Gerry Malanga, M.D., recent president of Interventional Orthobiologics Foundation, is the second principal investigator in our FDA-compliant pivotal/Phase III clinical trial for knee osteoarthritis.
His practice, New Jersey Regenerative Institute, a center to treat sports and orthopedic injuries in the Northeast, begins patient enrollment along with Tulane University School of Medicine and Texas Center for Cell Therapy and Research in San Antonio led by Jaime Garza, MD, DDS, FACS.
“We are excited to be a trial site for this innovative, potential treatment for knee osteoarthritis pain,” said Dr. Malanga.
Patients eligible for the trial will undergo an out-patient treatment in which:
- A physician harvests a small amount of fat tissue from the patient’s abdominal or gluteal region under local anesthetic.
- Using our SVF-2 technology platform, a patient’s own stromal cells will be isolated and concentrated into a cellular implant.
- Depending on randomization, a patient will receive either the cellular therapy (75% of patients) or placebo (25% of patients) injected into their knee under image guidance for precise placement and characterization.
In our randomized, controlled, FDA-compliant Phase IIb clinical trial, 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].
“This could be a great breakthrough for those hoping to avoid knee replacement surgery,” says Dr. Malanga. “Many of my patients who have had total knee replacement surgery didn’t fully understand what they were signing up for when they agreed to it. If they had been aware of the risks, they would have loved to have had an alternative treatment and delay knee replacement surgery as long as possible.”
For more information about the clinical trial, visit: https://clinicaltrials.gov/ct2/show/NCT04440189.
[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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