Status:
NOT_YET_RECRUITING
Study of Intracerebroventricular Injections of Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Participants With Mild-Moderate Alzheimer's Disease
Lead Sponsor:
Regeneration Biomedical, Inc.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
45-85 years
Phase:
PHASE2
Brief 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 prel...
Detailed Description
This is a randomized, placebo-controlled, dose range finding for safety and efficacy, Phase 2a U.S. multicenter study of repeated administration of RB-ADSC in participants with mild to moderate Alzhei...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- Taking prohibited medications
- Prior cell therapy implantation
- Existing ventriculoperitoneal shunts
- Neurological disorders except AD
- Psychiatric disorders such as schizophrenia, bipolar/unipolar depression, delirium
- Drug or alcohol abuse in past 2 years
- History of cancer within the past 5 years
- No caregiver available to meet the inclusion criteria for caregivers
- Involvement in other investigational product clinical trial within the past 3 months for monoclonal antibodies, or 6 months for other investigational products
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT07205601
Start Date
November 1 2025
End Date
March 1 2029
Last Update
October 3 2025
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