BioRestorative Therapies announced that the U.S. Food and Drug Administration has cleared an important amendment to the protocol of the ongoing Phase 2 study investigating the use of BRTX-100, the Company’s lead cell therapy candidate, in treating chronic lumbar disc disease. The protocol amendment removes saline injection in the control arm of the study and replaces it with a sham injection. BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is the Company’s lead clinical candidate. 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.
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- BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment
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- BioRestorative partners with Galen Patient Recruitment for BRTX-100 trial
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