Dr. Gregory Lutz, founder and Medical Director of RSI, will be the lead investigator for a new, FDA-approved, multi-center Phase 2 clinical trial. The double-blind, randomized, controlled study will assess the safety and efficacy of using intradiscal injections of BRTX-100—an autologous, biologic stem cell therapy designed by BioRestorative Therapies, Inc.—to treat degenerative-disc-related, chronic lower back pain among 72 patient test subjects, for whom traditional treatments have not worked.
This is a significant development, and Dr. Lutz is enthusiastic about the potential benefits for his patients and for the field of regenerative medicine, at large: “This treatment uses the patient’s own stem cells and has the potential to offer patients with chronic low back pain a less invasive and less risky alternative to lumbar fusion surgery. We are very excited that the FDA has given us the green light to begin this very important study.”
More information on BioRestorative Therapies and the clinical trial can be found at www.biorestorative.com.