Business
BioRestorative Therapies and Northwell Health Enter into Agreement to Participate in the Company’s Phase 2 Clinical Trial
New York State’s largest health care provider will participate in BRTX’s clinical trial Expansive universe of patients and clinical sites from which to
About this update from Biorestorative Therapies, Inc.
[{"type":"text","content":"New York State’s largest health care provider will participate in BRTX’s clinical trial Expansive universe of patients and clinical sites from which to recruit high quality subjectsLeverage Northwell’s “Center for Regenerative Orthopedic Medicine”Potential future collaborations to be explored in connection with basic science research MELVILLE, N.Y., May 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 it has signed a clinical trial agreement with Northwell Health, New York State's largest health care provider and private employer, and Northwell’s Feinstein Institutes for Medical Research. The signing of the agreement will allow Northwell Health to participate in BioRestorative Therapies ongoing Phase 2 clinical trial targeting chronic lumber disc disease (cLDD). 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. BRTX-100 is currently being evaluated in connection with a Phase 2 clinical trial to treat cLDD. The BRTX-100 approach involves an office based injection procedure which introduces the patient’s own cells which have been uniquely expanded and conditioned to result in therapeutic impact within the harsh environment of the intervertebral disc and for an all too common pain which is otherwise not reliably treated. 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. 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 enrollment for the safety run-in phase of its Phase 2 trial. Lance Alstodt, Chief Executive Officer of BioRestorative, stated, “Partnering with Northwell Health and Northwell’s Feinstein Institutes for Medical Research, the largest hospital system and health provider in New York State, is a testament to the strength of our corporate profile, our technology and the prospects for our product candidate, BRTX 100. We are delighted to enter into such an agreement with Northwell and their worl...