BioRestorative Completes 99-Patient Enrollment in Phase 2 Chronic Lumbar Disc Disease Trial
BioRestorative completed enrollment of 99 patients across 15 U.S. sites in its Phase 2 BRTX-100 trial for chronic lumbar disc disease, marking the largest FDA-authorized cell therapy study in this indication. The sham-controlled study measures safety by adverse events and requires over 30% ODI and pain improvement at 52 weeks.
1. Enrollment Milestone
BioRestorative has enrolled 99 participants at 15 U.S. clinical sites in its Phase 2 study of BRTX-100, randomizing patients 2:1 to receive stem cell therapy or placebo. This is the largest FDA-authorized cell therapy trial in chronic lumbar disc disease, reflecting accelerated site productivity.
2. Trial Design and Endpoints
The prospective, randomized, double-blind, sham-controlled single-disc study tracks safety through adverse event frequency and measures efficacy by requiring over 30% improvement in the Oswestry Disability Index and pain reduction at week 52. The design meets the gold standard for clinical rigor in spine interventions.
3. Regulatory Pathway Toward Phase 3
Completion of full enrollment bolsters the Company’s regulatory strategy after positive blinded data presentations and constructive FDA Type B meeting feedback. BioRestorative plans to engage regulators on Phase 3 study design and pursue a potential Biologics License Application submission.