RB-ADSC / Regeneration Biomedical - LARVOL DELTA

Autologous Stem Cell Approach Shows Promising Early Phase 1 Data in Alzheimer Disease (NeurologyLive) - "At the 18th Clinical Trials on Alzheimer’s Disease (CTAD) conference, held December 1-4 in San Diego, California, investigators presented encouraging early data from a phase 1 trial evaluating Regeneration Biomedical’s direct-to-brain autologous stem cell therapy for Alzheimer disease (AD). The treatment appeared safe and well tolerated, and the program is now advancing into a phase 2 study that opened enrollment in November...The early-stage study featured 9 patients, 7 of whom were included in the CTAD analysis. These participants were less than 80 years of age, had Mini Mental State Exam (MMSE) scores of 11 to 20, and exhibited elevated PET and cerebrospinal fluid (CSF) markers indicative of AD. In addition, this group had FAST stages of either 4 or 5."

Enrollment status • P1 data • Alzheimer's Disease

Study of Intracerebroventricular Injections of Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Participants With Mild-Moderate Alzheimer's Disease (clinicaltrials.gov) - P2 | N=115 | Not yet recruiting | Sponsor: Regeneration Biomedical, Inc.

New P2 trial • Alzheimer's Disease • CNS Disorders

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