Business
BioRestorative Therapies Announces Selection of 10 Clinical Sites for its Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease
MELVILLE, N.Y.,, April 18, 2022 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (NASDAQ: BRTX), a clinical stage
About this update from Biorestorative Therapies, Inc.
[{"type":"text","content":"MELVILLE, N.Y.,, April 18, 2022 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (NASDAQ: BRTX), a clinical stage company focused on stem cell-based therapies, today announced that it has selected 10 of its 15 clinical sites for its Phase 2 clinical trial targeting chronic lumbar disc disease. BioRestorative’s Phase 2 trial is a double-blind controlled, randomized study to evaluate the safety and preliminary efficacy of a single dose intradiscal injection of BRTX-100. A total of up to 99 eligible patients will be randomized at 15 centers in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion. The initial 10 clinical sites for the Phase 2 are located across the United States in the following cities: Greenwood Village, COTyler, TXCleveland, OHRichmond, VASt. Petersburg, FLTampa, FL (2 sites)North Charleston, SCWinston‐Salem, NCSan Diego, CA “We are pleased to have selected our initial clinical sites and look forward to initiating patient enrollment”, said Lance Alstodt, the Company’s CEO. “The caliber of clinics that have been selected represents some of the best spine care facilities in the country as this selection process represents a major milestone for BioRestorative. We believe that an intradiscal injection of BRTX-100 has the potential to transform the treatment paradigm for patients suffering from chronic lumbar disc disease.” About BioRestorative Therapies, Inc. BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to ...