Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease
Recruiting now · Phase 1
Conditions studied: Alzheimer Disease
In brief
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.
Key facts
- Study ID
- NCT05667649
- Run by
- Regeneration Biomedical, Inc.
- People needed
- 18
- Starts
- 2023-08-14
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2025-04-04
Who can join
Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥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
You may not qualify if…
- 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
- Stem cell implantation of any type within 3 months
- Existing ventriculoperitoneal shunts
- Neurological disorders except AD
- Psychiatric disorders including schizophrenia, bipolar/unipolar depressive disorder, delirium
- Drug or alcohol abuse or dependence within the past 5 years
- Participants with a history of cancer in the past 5 years
- No caregiver available to meet the inclusion criteria for caregivers
Where it is running
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
Full record on ClinicalTrials.gov
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