RB-ADSC / Regeneration Biomedical - LARVOL DELTA

Regeneration Biomedical to Present Updated Phase 1 Trial Data on Autologous Stem Cell Therapy Injected Directly into the Brain for Alzheimer’s Disease in Podium Presentation at the ISCT 2025 Scientific Annual Meeting (GlobeNewswire) - P1 | N=18 | NCT05667649 | Sponsor: Regeneration Biomedical, Inc. | "Abstract selected for a podium presentation and winner of the Host Region (US West) Award; First-in-human data now includes five patients, with follow-up ranging from 23 weeks to over a year post-treatment; Injections of Wnt-activated, autologous, expanded, adipose-derived stem cells (RB-ADSCs) delivered directly into the brain have shown no major adverse events from 23 to 55-week follow-up; After a single injection, 80% of patients showed improvements in Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) scores, normalization of p-Tau and decreased amyloid beta levels; 60% showed improvements Mini-Mental Status Examination (MMSE) scores."

P1 data • Alzheimer's Disease

Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Regeneration Biomedical, Inc. | Trial completion date: Mar 2025 ➔ Aug 2026 | Trial primary completion date: Feb 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Regeneration Biomedical Presents Data on First Cohort from an Ongoing Phase I Clinical Trial of Stem Cell Therapy Delivered Directly into the Brains of Patients with Alzheimer’s Disease (GlobeNewswire) - P1 | N=18 | NCT05667649 | Sponsor: Regeneration Biomedical, Inc. | "Wnt-activated, autologous, expanded, adipose-derived stem cells (RB-ADSCs) administered directly into lateral ventricles of the brain were well tolerated and reduced levels of p-Tau and amyloid-beta at 12 weeks; Mini-Mental State Examination (MMSE) scores improved in two of three subjects; Data presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid, 3 to 5 p.m. CET, October 29 and 30, 2024."

P1 data • Alzheimer's Disease

Regeneration Biomedical Doses First Patient in a First-in-Human Phase I Clinical Trial of Stem Cell Therapy delivered directly into the brain of Patients with Alzheimer’s Disease (GlobeNewswire) - "Regeneration Biomedical...announced that the first patient has been dosed in an FDA-cleared, first-in-human Phase 1 clinical trial of autologous, Wnt-Activated Adipose-Derived Stem Cells (RB-ADSC) for patients with mild-to-moderate Alzheimer’s disease (AD)....This FDA-cleared, Phase 1 open-label, single-arm study will enroll nine subjects over one year randomized into a 3 + 3 dose escalation design to evaluate the safety of autologous RB-ADSC infused into the lateral ventricles of the brain in subjects with mild-to-moderate AD, and to determine a recommended dose for a potential Phase 2 clinical trial. Secondary endpoints include AD clinical assessments and biochemical and anatomical biomarkers."

Trial status • Alzheimer's Disease

RB-ADSC for Treatment of Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Regeneration Biomedical, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

RB-ADSC for Treatment of Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Regeneration Biomedical, Inc. | Trial completion date: Aug 2024 ➔ Nov 2024 | Initiation date: Jan 2023 ➔ Apr 2023 | Trial primary completion date: Jul 2024 ➔ Oct 2024

Trial completion date • Trial initiation date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

RB-ADSC for Treatment of Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Regeneration Biomedical, Inc.

New P1 trial • Preclinical • Alzheimer's Disease • CNS Disorders