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BioRestorative to Present Stem Cell Trial Data for Back Pain at Global Conference

Benzinga·06/09/2025 11:48:13
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BioRestorative Therapies, Inc. ("BioRestorative," "BRTX" or the "Company") (NASDAQ:BRTX), a clinical-stage regenerative medicine company developing stem cell-based therapies for serious musculoskeletal conditions, today announced that new preliminary, blinded clinical data from 30 patients enrolled in its ongoing Phase 2 trial of BRTX-100 for the treatment of chronic lumbar disc disease (cLDD) will be presented at the prestigious International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting, held June 11–14, 2025, in Hong Kong.

The highly anticipated presentation will be delivered by Francisco Silva, Vice President of Research and Development at BioRestorative, on Friday, June 13, at 5:00 p.m. HKT, as part of ISSCR 2025's clinical innovations track. The Company will issue a press release pre-market that day, detailing the newly reported data.

"This represents a milestone moment for BioRestorative," said Lance Alstodt, Chief Executive Officer. "With preliminary data from twice as many patients as previously shared, we are seeing strong, consistent signals around both safety and functional improvement. We are eager to bring this update to the global scientific community at the world's most influential stem cell conference."

BRTX-100 is BioRestorative's lead clinical candidate — a hypoxic-cultured, autologous mesenchymal stem cell therapy designed to target areas of the body with limited blood flow, such as damaged spinal discs. The ongoing Phase 2 study is a prospective, randomized, double-blinded, placebo-controlled trial evaluating BRTX-100 in patients with cLDD across up to 16 U.S. clinical sites. A total of 99 patients will be enrolled, randomized 2:1 to receive either BRTX-100 or placebo via a single intradiscal injection.

The 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 highlight key preliminary outcomes focused on patient-reported pain and function metrics, as well as safety endpoints.