BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment
— Amendment replaces saline injections with sham injections in the control group —
MELVILLE, N.Y., April 16, 2024 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that the U.S. Food and Drug Administration (“FDA”) 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 (“cLDD”). The protocol amendment removes saline injection in the control arm of the study and replaces it with a sham injection.