BioRestorative Therapies Announces Phase 2 Clinical Trial Data

BioRestorative Therapies announced blinded data from its Phase 2 clinical trial evaluating hypoxic-cultured mesenchymal stem cells for the treatment of chronic lumbar disc disease, with 50% or more of treated patients reporting improvements greater than 50% across key pain and functional outcome measures and no adverse events related to dose-limiting toxicities. Importantly, the Phase 2 study efficacy endpoint is a greater than a 30% improvement in both the Visual Analog Scale and Oswestry Disability Index at 52 weeks, which is the minimum improvement needed to meet clinical efficacy success. 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. These data were presented at the 2026 Orthopaedic Research Society annual meeting on March 28 at the Charlotte Convention Center in Charlotte, North Carolina. Clinically meaningful improvements in both pain and functional outcomes were observed across multiple validated pain and function measures, including the Visual Analog Scale, Oswestry Disability Index, Roland-Morris Disability Questionnaire, and Functional Rating Index, with responses sustained for up to two years in patients with longer-term follow-up. On the VAS for pain, 53.57% of patients reported greater than 50% improvement at 26 weeks, with the percentage of patients that reported greater than 50% improvement increasing to 75% at 52 weeks and remaining 75% at 104 weeks. Similar improvements were observed on the ODI, a widely used measure of functional impairment associated with spinal disorders. Blinded results from the abstract showed 53.57% of patients achieved greater than 50% improvement at 26 weeks, increasing to 74.63% of patients at 52 weeks, with 50% of patients maintaining that level of improvement at 104 weeks. Improvements were also observed on the RMDQ, with 57.14% of patients experiencing greater than 50% improvement at 26 weeks, 50% of patients at 52 weeks, and 75% of patients at 104 weeks. FRI demonstrated continued improvement over time, with 35.71% of patients achieving greater than 50% improvement at 26 weeks, increasing to 66.67% of patients at 52 weeks and 50% of patients at 104 weeks. Finally, at 26 weeks 41% of patients reported a 50% improvement in both ODI and VAS, 55% of patients achieved a 50% improvement in both ODI and VAS at 52 weeks, and at 104 weeks 57% of patients met a 50% improvement in both ODI and VAS.