BioRestorative Therapies (NASDAQ: BRTX) has announced that new preliminary 26- to 52-week blinded data from the Phase 2 clinical trial of BRTX-100 in patients with chronic lumbar disc disease (cLDD) will be presented at the at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium, taking place November 10-14, 2024, in Skytop, Pennsylvania.
The safety and efficacy of BRTX-100 in treating cLDD are being evaluated in a Phase 2, prospective, randomized, double-blind, and controlled study. Up to 99 eligible subjects will be enrolled at 16 clinical sites across the United States. Participants will be randomized in a 2:1 ratio to receive either BRTX-100 or a placebo (sham injection).
“We are excited by this opportunity to share new and additional preliminary data from the ongoing Phase 2 clinical trial of BRTX-100 in the treatment of cLDD,” said Lance Alstodt, CEO of BioRestorative.
“In February 2024, we were strongly encouraged that the Visual Analog Scale, Oswestry Disability Index, Roland Morris Disability Questionnaire, and Functional Rating Index collected at 26 and 52 weeks after injection indicated a positive trend compared to the baseline with the first four patients enrolled in the study. Now at ORS PSRS 2024 next week, we expect to reveal blinded data on a significantly higher number of study subjects over a longer period of time,” Mr. Alstodt added.
The podium presentation, titled “Stem Cell Therapy for Chronic Lumbar Disc Disease: Phase 2 Clinical Safety and Feasibility Data of Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells,” will be delivered by Francisco Silva, vice president of research and development at BioRestorative. It is scheduled for Wednesday, November 13, 2024, between 9:40 am and 10:00 am EST.
