NCT05667649CompletedPhase 1
Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease
Ph 1, Open-Label Safety Study of Escalating Doses of Intracerebroventricular Injections of Ex Vivo Expanded, Autologous ADSCs in Participants With Mild-Moderate AD Whose Treatment is Not Addressed Adequately by Available Therapy
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
This is a research study to evaluate the safety of an investigational autologous cell product obtained from participant's own adipose tissue as a possible treatment for Alzheimer disease.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 1 Dec 2022
- Start date
- 14 Aug 2023
- Primary completion date
- 25 Jun 2026
- Lead sponsor
- Regeneration Biomedical, Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT05667649
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 7
- From 14 Aug 2023 to the primary completion date, 25 Jun 2026
- 1 site in 1 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 other medications for AD, except that donepezil memantine, AChEIs including patches, Vitamin E, fish oil, and/or gingko biloba are allowed if doses have been stable for at least 3 months prior to the Screening visit
- Drug or alcohol abuse or dependence within the past 5 years
Other illness
- Neurological disorders except AD
- Psychiatric disorders including schizophrenia, bipolar/unipolar depressive disorder, delirium
- Participants with a history of cancer in the past 5 years
Other
- Stem cell implantation of any type within 3 months
- Existing ventriculoperitoneal shunts
- No caregiver available to meet the inclusion criteria for caregivers
Who the study is looking for
- ≥45 and ≤80 years of age
- Mild to moderate AD diagnosis
- Adequate cognitive function
- Non-remarkable clinical laboratory
- Ability to voluntarily provide written informed consent
- No tumors or other disease responsible for dementia
- Well-controlled comorbidities, on stable medications for 3 months
- The participant is otherwise in good general health
- The participant must have a relative/caregiver
- Participant must be able to donate adequate amount of lipoaspirate to establish the final product
- Caregiver separately meets the specified inclusion/exclusion criteria for caregivers
Age in the registry: 45 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hoag Memorial Hospital Presbyterian Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.