Regeneration Biomedical Inc. has received FDA Fast Track designation for a stem cell therapy that delivers Wnt-activated fat-derived stem cells directly into the brain to treat Alzheimer's disease. In a first-in-human Phase 1 trial presented in 2025, the therapy appeared safe and showed encouraging biological signals — including reductions in phosphorylated tau, improved amyloid PET scans, and changes in cerebrospinal fluid proteins linked to brain health. The treatment bypasses the blood-brain barrier by using a surgically implanted device called an Ommaya reservoir. FDA Fast Track status means regulators recognize an unmet medical need and will work more closely with RBI to speed development. A randomized, placebo-controlled Phase 2 trial is now cleared to proceed.
