BioRestorative Therapies (NASDAQ: BRTX) announced the presentation of promising preliminary blinded data from the first 36 subjects in its ongoing Phase 2 clinical trial of BRTX-100, an autologous stem cell therapy for chronic lumbar disc disease (cLDD). This data was shared at the ISSCR 2025 Annual Meeting in Hong Kong by Francisco Silva, VP of Research and Development.
The FDA is requiring at least a greater than 30% improvement in function in the Oswestry Disability Index (ODI) and a greater than 30% reduction in pain on the Visual Analog Scale (VAS) in determining whether the clinical trial will be allowed to proceed and ultimately gain Biologics License Application approval.
In a statement, Lance Alstodt, CEO of BioRestorative, commented, “With every new analysis, our confidence grows that BRTX-100 is positioned to meet and potentially exceed the FDA’s functional and pain reduction thresholds.”
Mr. Alstodt added, “We are excited by the trajectory of this material milestone and its potential to address a massive unmet need in chronic lower back pain—one of the largest global healthcare burdens. We believe this data moves us one step closer to bringing a much-needed, non-surgical therapeutic option to market and should add to further value enhancing inflection points in the near-term.”
Key Highlights Include:
- Patient Numbers Growing: The number of subjects evaluated has increased from 15 to 36 since the company’s last press release — an important milestone toward full Phase 2 enrollment (up to 99 subjects).
- Compelling Clinical Signals:
- Over 74% of subjects showed >50% improvement in function (ODI) by 52 weeks
- Over 72% of subjects reported >50% reduction in pain (VAS) by 52 weeks
- Combined >50% improvement in both ODI and VAS measures was achieved by a meaningful portion of subjects across all timepoints.
- Excellent Safety Profile: No serious adverse events or dose-limiting toxicities reported between 26 and 104 weeks at the target dose (40 million cells).
- Strengthening Data: Each new data analysis has outperformed prior releases, highlighting an upward trend in efficacy markers.
The data were presented as part of the Clinical Innovations track at ISSCR 2025, an event that attracts the world’s top stem cell and regenerative medicine researchers, clinicians, and investors.
