BioRestorative Therapies, Inc. (the "Company" or "BioRestorative") (NASDAQ:BRTX), a clinical stage biopharmaceutical company focused on stem cell-based therapies, today announced that it is hosting a Principal Investigators Meeting in Uniondale, NY on April 29th - 30th, 2022 for the Company's lead clinical candidate BRTX-100®, an autologous bone marrow-derived hypoxic cultured stem cell intended for investigational use in its Phase 2 clinical trial to treat chronic lumbar disc disease.
The meeting will be attended by all principal investigators currently selected across the United States to help coordinate the study, entitled "A Phase 2, Double-Blind, Saline-Controlled, Randomized Study to Evaluate the Safety and Preliminary Efficacy of a Single Dose Intradiscal Injection of BRTX-100 for Patients with Chronic Lumbar Disc Disease (cLDD)"
"I'm pleased to announce that we continue to execute our BRTX-100® development plan in accordance with our previously stated timeline objectives," said Lance Alstodt, Chief Executive Officer of BioRestorative Therapies. "The Principal Investigator Meeting will be attended in person and will enable a mutual understanding of the study's goals and set best in class procedures to share experiences among the Principal Investigators."
The Company plans to recruit 99 subjects for its Phase 2 trial in 15 leading clinical sites across the United States.
Low back pain (LBP) is a common, often confounding, problem for patients and physicians. In the United States, at least 80% of adults experience at least one episode of LBP during their lifetime. Low back pain is the most common cause of disability among Americans between 45 and 65 years of age. Further, of all musculoskeletal conditions, LBP imposes the highest economic burden on the U.S. healthcare system.