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.
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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.
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By GlobalData“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.”
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