BioRestorative Therapies has concluded patient enrolment in its Phase II study evaluating the efficacy and safety of BRTX-100 for chronic lumbar disc disease (cLDD).

BRTX-100 is an autologous, hypoxically cultured mesenchymal stem cell therapy designed for delivery into low-oxygen, low-nutrient disc settings.

The randomised, prospective, double-blind, sham-controlled trial enrolled 99 subjects across 15 sites in the US, focusing on single-disc disease. Participants were randomised into 2:1 ratio to receive either the therapy or placebo through a minimally invasive outpatient intradiscal procedure.

The trial’s primary safety endpoint is to assess the severity and frequency of adverse events. Efficacy endpoints include an improvement exceeding 30% in function as measured by the Oswestry Disability Index and a greater than 30% decrease in pain on the Visual Analog Scale compared to baseline at week 52.

BioRestorative CEO Lance Alstodt said: “This is a defining operational and clinical milestone for BioRestorative. Completing enrolment in what we believe is the largest and most rigorously designed Phase II cell-therapy trial in chronic lumbar disc disease represents years of disciplined execution and scientific focus.

“This is not only a scale milestone — it is a quality milestone. A randomised, double-blind, sham-controlled, single-disc trial sets a high evidentiary bar and positions the programme for meaningful regulatory dialogue and advancement.

“Indeed, based on the compelling preliminary blinded Phase II data we have reported to date, together with constructive feedback from our recent FDA Type B meeting, we believe we have a clear and actionable pathway toward Phase III development and a potential BLA submission. We look forward to providing additional updates as we advance the programme in the very near future.”