BioRestorative Therapies, Inc. announced a collaboration with Galen Patient Recruitment, Inc. (Galen) which, combined with the recent expansion of clinical trial capacity from approximately 10 to 30 participants per month, is expected to help accelerate the completion of patient enrollment in the ongoing Phase 2 study of BioRestorative?s lead clinical candidate, BRTX-100, in chronic lumbar disc disease (cLDD). BRTX-100 is a novel cell-based therapeutic engineered to target areas of the body that have little blood flow. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double blinded and controlled study.

A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo. Brøgger-Mikkelsen M, Ali Z, Zibert JR, Andersen AD, Thomsen SF.

Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Nov.

4;22(11):e22179. doi: 10.2196/22179. PMID: 33146627; PMCID: PMC7673977.