MELVILLE, NY - BioRestorative Therapies (NASDAQ:BRTX), a clinical-stage biotech company, has announced preliminary data from a Phase 2 trial of its lead therapeutic candidate, BRTX-100, showing a positive trend in treating chronic lumbar disc disease (cLDD). The data, presented at the Orthopaedic Research Society (ORS) 2024 Annual Meeting, indicates potential improvements in pain and mobility for patients.
BRTX-100 is a cell-based therapy using the patient's own stem cells, cultured under low oxygen conditions to better adapt to the low oxygen environment of the intervertebral disc. The treatment aims to regenerate damaged discs in the lower back, which could lead to reduced pain and enhanced function for sufferers of cLDD.
The ongoing double-blinded study is enrolling up to 99 subjects across up to 16 U.S. clinical sites. Although the data remains blinded, early results based on pain and function questionnaires—such as the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI)—collected at 26 and 52 weeks post-treatment, suggest improvements from baseline.
Lance Alstodt, CEO of BioRestorative, expressed optimism about the preliminary findings, stating that the data shows meaningful patient improvements and no notable safety concerns. If the FDA approves BRTX-100, it could become a first-of-its-kind, less invasive treatment for chronic back pain.
The treatment involves a minimally invasive procedure to harvest bone marrow and blood, with a short recovery time. This personalization of the therapy could be a significant advancement in the field of orthobiologic treatments for disc-related pain.
BioRestorative's progress in the treatment of cLDD places it among other companies in the competitive cell-based biologics and chronic pain treatment market, such as Mesoblast (NASDAQ:MESO), Brainstorm Cell Therapeutic, and Longeveron.
The company's pursuit of a Biologics License Application (BLA) with the FDA continues as it seeks to validate the safety and efficacy of BRTX-100. The information presented in this article is based on a press release statement from BioRestorative Therapies.
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