Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease
Recruiting · NCT05667649 · Interventional (participants receive a specific treatment) · Lead sponsor: Regeneration Biomedical, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
RB-ADSC
What this trial is about
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.
Who can take part
Age range
45 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- ≥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
- Exclusion Criteria:
- 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
1 location listed across 1 US state.
- Hoag Memorial Hospital Presbyterian - Newport Beach, California, United States