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BioRestorative Therapies Announces Activation of Northwell Health in the Company's Phase 2 Clinical Trial Targeting Chronic Lumbar Disc Disease
--Site activation allows for patients in the State of New York to participate in the BRTX-100 trial— --15 Clinical Sites Identified, 12 of the 15 Activated
About this update from Biorestorative Therapies, Inc.
[{"type":"text","content":"--Site activation allows for patients in the State of New York to participate in the BRTX-100 trial— --15 Clinical Sites Identified, 12 of the 15 Activated and Recruiting Subjects MELVILLE, N.Y., Sept. 08, 2023 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc . (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: BRTX ) , a clinical stage company focused on stem cell-based therapies, today announced that Northwell Health, New York State's largest health care provider, has been activated and can now start recruitment in the State of New York for BioRestorative’s ongoing Phase 2 clinical trial targeting chronic lumbar disc disease (“cLDD”). BioRestorative and Northwell Health entered into a clinical trial agreement in May with regard to the Phase 2 trial. Much effort and collaboration have taken place and, now that site specific training is complete, the site can initiate patient recruitment and enrollment. BRTX-100, the Company’s lead clinical candidate, is a novel cell-based therapeutic engineered to target areas of the body that have little blood flow and limited oxygen supply. It is currently being evaluated in connection with the Company’s ongoing Phase 2 clinical trial targeting cLDD. The trial is prospective, randomized, double-blinded and controlled. The trial will evaluate the safety and preliminary efficacy of a single dose of BRTX-100, with 40 million cells injected into the lumbar disc that is causing pain. A total of up to 99 eligible patients will be randomized at up to 15 clinical sites in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion. BioRestorative recently completed its safety run-in phase of the Phase 2 trial and is now openly enrolling patients across all its clinical sites located throughout the United States. “I’m pleased to report that, after several months of a deliberate and thoughtful collaboration with Northwell Health, the largest healthcare provider and employer in New York State, we have reached the point of initiating the patient enrollment process. Given the size of Northwell Health and its relative proximity to our facilities in Melville, New York, we look forward to significant benefits from working with Northwell Health in connection with our Phase 2 clinical trial. We hope that our partnership will result in a highly efficient recruitment / ...