BioRestorative Therapies Inc. (BRTX), announced completion of patient dosing in its fully enrolled Phase 2 clinical trial of BRTX-100, its lead stem cell-based therapy for chronic lumbar disc disease.
Chronic lumbar disc disease (cLDD), is a degenerative spine condition that causes persistent lower back pain and functional impairment.
The randomized, double-blind, sham-controlled study enrolled 99 patients across U.S. sites. Participants received either BRTX-100 or control treatment, with follow-up assessments scheduled through 104 weeks. The primary efficacy endpoint measures at least a 30% improvement in both pain and function at week 52, while MRI evaluations will assess disc changes at baseline, week 52, and week 104.
BRTX-100 is BioRestorative's proprietary autologous, hypoxically cultured mesenchymal stem cell therapy designed for delivery into the harsh, low-oxygen, low-nutrient environment of the intervertebral disc. Patients in the trial received a single intradiscal injection of 40 million cells via a minimally invasive outpatient procedure.
CEO Lance Alstodt called the milestone "an important transition point," noting that the program is now moving through blinded follow-up toward topline safety and efficacy data expected in Q2 2027. He added that the company is continuing Phase 3 readiness activities following FDA alignment at a Type B meeting, where no clinical safety concerns were raised.
BioRestorative has previously reported favorable blinded safety and preliminary efficacy data, including sustained improvements in pain and function and MRI findings suggestive of disc remodeling. The therapy has received FDA Fast Track designation for chronic lumbar disc disease.
BRTX has traded between $0.15 and $2.04 over the past year. The stock is currently trading at $0.24, up 20.14%.
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