drugset / Trial / NCT07205601

Study of Intracerebroventricular Injections of Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Participants With Mild-Moderate Alzheimer's Disease

NCT07205601 ↗

Phase 2 Not yet recruiting 115 enrolled Regeneration Biomedical, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this Phase 2 clinical trial is to learn if repeated dosing of RB-ADSC (an investigational autologous cell product obtained from participant's own adipose tissue) enhances the positive preliminary results seen in Phase 1 for the of treatment for mild to moderate Alzheimer's Disease in adults. The clinical trial will also continue to evaluate the safety of repeated dosing of RB-ADSC. This study will primarily evaluate the effects of repeated dosing of RB-ADSC on cognitive performance compared to placebo control. Participants will receive RB-ADSC every 2 months for a total of 6 doses. Participants randomized into the placebo control group will have the option to cross over to receive treatment after completion of the primary phase of the study.

Timeline

Start
2025-11
Primary completion
2028-03
Completion
2029-03

Drugs

EvaluationDrugModalityDoseRoute
Subject RB-ADSC Cell therapy 2.5e+06 cells Other
Subject RB-ADSC Cell therapy 5e+06 cells Other

Indications