NCT07205601Not yet recruitingPhase 2
Study of Intracerebroventricular Injections of Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Participants With Mild-Moderate Alzheimer's Disease
Phase 2a Assessment of Safety, Tolerability, and Efficacy of Repeated Dosing of Intracerebroventricular Injections of Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Participants With Mild to Moderate Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- First submitted
- 17 Sept 2025
- Start date
- Oct 2026
- Primary completion date
- Feb 2029
- Lead sponsor
- Regeneration Biomedical, Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT07205601
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 115
- From Oct 2026 to the primary completion date, Feb 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking prohibited medications
- Prior cell therapy implantation
- Drug or alcohol abuse in past 2 years
- Involvement in other investigational product clinical trial within the past 3 months for monoclonal antibodies, or 6 months for other investigational products
Other illness
- Neurological disorders except AD
- Psychiatric disorders such as schizophrenia, bipolar/unipolar depression, delirium
- History of cancer within the past 5 years
Other
- Existing ventriculoperitoneal shunts
- No caregiver available to meet the inclusion criteria for caregivers
Who the study is looking for
- ≥45 and ≤85 years of age
- Mild to moderate AD diagnosis
- FAST stage 4 or 5
- MMSE 10-23
- Amyloid PET scan centiloid score \>30
- ADmark® CSF analysis of ATI (\<1.0) and P-Tau (\>60)
- No tumors or other disease responsible for dementia
- Participant otherwise in good general health
- Written informed consent from participant or legal representative
- Participant must have caregiver who separately meets specified inclusion/exclusion criteria for caregivers
- Participant must be able to donate adequate amount of lipoaspirate to establish the final product
Age in the registry: 45 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.