BioRestorative Completes Enrollment in Phase 2 Stem Cell Trial for Chronic Lumbar Disc Disease
They've completed enrollment of 99 patients across 15 U.S. sites in its Phase 2 trial evaluating BRTX-100, a mesenchymal stem cell therapy for chronic lumbar disc disease.
Key findings
- BioRestorative has completed enrollment in a Phase 2 trial of BRTX-100 for chronic lumbar disc disease.
- The study enrolled 99 patients across 15 U.S. sites, randomized 2:1 to BRTX-100 vs placebo.
- Primary efficacy endpoints at week 52 include at least 30% improvement in function (ODI) and at least 30% pain reduction (VAS) vs baseline.
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BioRestorative Therapies has finished enrolling patients in its Phase 2 trial evaluating BRTX-100 for chronic lumbar disc disease (cLDD). The company says the study enrolled 99 participants across 15 U.S. clinical sites.
What is BRTX-100
BRTX-100 is BioRestorative’s lead clinical candidate; it’s an autologous (patient-derived) mesenchymal stem cell (MSC) therapy that is hypoxically cultured (grown under low oxygen conditions) to support delivery into intervertebral discs, which are also low-oxygen and low-nutrient environments.
Trial design
The Phase 2 trial is prospective, randomized, double-blind, and sham-controlled, and it focuses on single-disc disease. Participants were randomized 2:1 to receive BRTX-100 or placebo via a minimally invasive outpatient intradiscal procedure.
Endpoints
The primary safety endpoint is the frequency and severity of adverse events (AEs). Primary efficacy endpoints are:
- Greater than 30% improvement in function on the Oswestry Disability Index (ODI) vs baseline at week 52
- Greater than 30% reduction in pain on the Visual Analog Scale (VAS) vs baseline at week 52
The company notes that single-disc enrollment criteria are restrictive and can be difficult to meet, and that roughly 40% of enrollment occurred in the last six months.
“This is a defining operational and clinical milestone for BioRestorative,” said Lance Alstodt, Chief Executive Officer. “Completing enrollment in what we believe is the largest and most rigorously designed Phase 2 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 randomized, double-blind, sham-controlled, single-disc trial sets a high evidentiary bar and positions the program for meaningful regulatory dialogue and advancement,” added Mr. Alstodt. “Indeed, based on the compelling preliminary blinded Phase 2 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 3 development and a potential BLA submission. We look forward to providing additional updates as we advance the program in the very near future.”
Company snapshot
BioRestorative develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. The company’s programs include its disc/spine program (brtxDISC), its metabolic program (ThermoStem, including work involving brown adipose (fat) derived stem cells (BADSC), brown adipose tissue (BAT), and exosomes), and a commercial “BioCosmeceutical” platform the company describes as a cell-based secretome containing exosomes, proteins, and growth factors.
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