BioRestorative Therapies, Inc., a clinical-stage company specializing in stem cell-based therapies, has announced the activation of Northwell Health, the largest healthcare provider in New York State, for its ongoing Phase 2 clinical trial targeting chronic lumbar disc disease (cLDD). This activation permits patients in New York to participate in the BRTX-100 trial.
The collaboration between BioRestorative and Northwell Health began with a clinical trial agreement in May. With site-specific training now completed, Northwell Health can commence patient recruitment and enrollment. BRTX-100, BioRestorative’s primary clinical candidate, is an innovative cell-based therapeutic designed to target regions of the body with minimal blood flow and oxygen supply.
The current Phase 2 clinical trial aims to assess the safety and preliminary efficacy of a single BRTX-100 dose, where 40 million cells are injected into the lumbar disc causing pain. The trial plans to involve up to 99 patients across 15 clinical sites in the U.S., with participants receiving either the investigational drug (BRTX-100) or a control in a 2:1 ratio.
Lance Alstodt, the CEO of BioRestorative, expressed his enthusiasm about the collaboration with Northwell Health, anticipating significant benefits from the partnership, especially in patient enrollment. Dr. Sohrab Virk from Northwell Health echoed this sentiment, highlighting the potential of BRTX-100 in improving clinical outcomes related to spine issues.
Northwell Health, with its 21 hospitals, 850 outpatient facilities, and over 12,000 affiliated physicians, is poised to play a crucial role in the trial, especially in recruiting and enrolling patients suffering from chronic lumbar disc disease.
About BioRestorative Therapies, Inc.:
BioRestorative Therapies focuses on developing therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Their main programs target the treatment of disc/spine disease and metabolic disorders. The BRTX-100 product, derived from a patient’s bone marrow stem cells, is intended for non-surgical treatment of painful lumbosacral disc disorders or as an adjunct to surgical procedures.
For further inquiries, BioRestorative can be reached at firstname.lastname@example.org