BioRestorative Therapies Releases BRTX-100 Clinical Trial Data
BioRestorative Therapies announced expanded blinded data from its fully enrolled Phase 2 clinical trial evaluating BRTX-100, the Company's autologous hypoxic-cultured mesenchymal stem cell therapy for the treatment of chronic lumbar disc disease. The data were presented in an oral presentation at the International Society for Cell & Gene Therapy Annual Meeting on May 6, 2026, at The Convention Centre Dublin in Dublin, Ireland. The presentation, titled "Late-Stage Phase 2 Clinical Safety and Efficacy Data on Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells: Study Update," included a larger 52-week follow-up cohort than previously reported and continued to show clinically meaningful improvements across validated pain and functional outcome measures. Chronic lumbar disc disease is a leading cause of chronic lower back pain and disability, affecting millions of patients globally and representing a significant unmet need for non-surgical regenerative therapies. At 52 weeks, 52% of evaluable patients achieved at least 50% improvement in both the Visual Analog Scale for pain and the Oswestry Disability Index for function. The number of patients evaluated at 52 weeks more than doubled compared with the Company's previously reported ORS 2026 dataset, increasing from 12 patients to 25 patients, while continuing to show favorable safety outcomes and no adverse events related to dose-limiting toxicities associated with hypoxic-cultured mesenchymal stem cells. The Phase 2 study is designed to evaluate, among other measures, pain reduction using VAS and functional improvement using ODI at 52 weeks. The study's efficacy criteria include at least a 30% decrease in pain and at least a 30% improvement in function at 52 weeks. The blinded ISCT dataset showed that a substantial portion of evaluable patients exceeded that threshold, achieving at least 50% improvement across key measures. Clinically meaningful improvements in both pain and functional outcomes were observed across multiple validated pain and function measures, including the VAS, ODI, Roland-Morris Disability Questionnaire, and Functional Rating Index, with responses sustained for up to two years in patients with longer-term follow-up. Specifically: On VAS for pain, 56% of evaluable patients reported at least 50% improvement at 52 weeks, with an average improvement of 71.4%. At 104 weeks, average improvement increased to 73.8%. On ODI, a widely used measure of functional impairment associated with spinal disorders, 64% of evaluable patients achieved at least 50% improvement at 52 weeks, with an average improvement of 73.6%. At 104 weeks, average improvement was 68%. At 52 weeks, 52% of evaluable patients achieved at least 50% improvement in both VAS and ODI, a combined measure reflecting simultaneous improvement in pain and function. On FRI, 56% of evaluable patients reported at least 50% improvement at 52 weeks, with an average improvement of 69.7%. At 104 weeks, average improvement was 58.6%/ On RMDQ, 56% of evaluable patients experienced at least 50% improvement at 52 weeks, with an average improvement of 85.9%. At 104 weeks, average improvement was 73.6%
