Regeneration Biomedical, Inc. (RBI) has been granted Fast Track designation by the U.S. Food and Drug Administration for its direct-to-brain, Wnt-activated autologous adipose-derived stem cell therapy for Alzheimer’s disease.
The company completed a first-in-human Phase 1 study that it presented at the Clinical Trials on Alzheimer’s Disease meeting in 2025 and claims the trial showed safety and tolerability alongside supportive changes in cerebrospinal fluid proteomics, reductions in phosphorylated tau, improved amyloid PET measures and exploratory cognitive signals.
RBI states the therapy is delivered intracerebroventricularly via an Ommaya reservoir to expose the central nervous system while bypassing the blood-brain barrier.
The FDA designation and the agency clearance to proceed into a randomized, placebo-controlled, multi-center Phase 2 trial support the program’s advancement.
The announcement frames the Fast Track status as recognition of an unmet need and a step to expedite development and regulatory engagement for the direct-to-brain regenerative approach.
