BioRestorative to reveal Phase 2 lumbar disc safety data and exosome proteomics

BioRestorative Therapies has scheduled two presentations at the International Society for Cell & Gene Therapy Annual Meeting in Dublin on May 6. The morning session will feature safety and blinded efficacy findings from its fully enrolled Phase 2 study of hypoxic cultured MSC intradiscal injections in chronic lumbar disc disease, while the evening session will showcase MSC exosome proteomics preclinical research.

The Phase 2 trial employs BRTX-100, an autologous mesenchymal stem cell product cultured under hypoxic conditions and injected into damaged lumbar discs. The study is fully enrolled and focuses on safety endpoints and blinded efficacy assessments in patients with persistent lumbosacral disc pain unresponsive to non-invasive therapies. An IND clearance also covers evaluation of BRTX-100 in chronic cervical discogenic pain.

Preclinical data will detail source-specific MSC exosome proteomics, highlighting potential therapeutic and cosmetic applications. BioRestorative’s BioCosmeceutical platform utilizes a cell-based secretome enriched with exosomes, growth factors and peptides, all formulated in a cGMP, ISO-7 cleanroom to support skin health and anti-aging performance.

Beyond the spinal program, the company is advancing ThermoStem®, a brown adipose-derived stem cell therapy targeting obesity and metabolic disorders through brown fat induction and exosome delivery. BioRestorative also plans IND-enabling studies to expand its cell-based biologic aesthetic products and pioneer FDA approvals in the emerging BioCosmeceuticals sector.