Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Bernard (Barry) Baumel
- Study ID
- NCT06781333
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Agitation in Dementia
- Alzheimer Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 55 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- hMSC — BIOLOGICALParticipants will come in person to receive one intravenous infusion of approximately 25 million cells up to 20 minutes.
Study Details
The purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe Alzheimer's disease.
Key Dates
- Start date
- Apr 29, 2025
- Status verified
- May 2026
- Primary completion
- Dec 15, 2027
- Completion
- Dec 15, 2027
Study Design
- Enrollment
- 8 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: hMSC groupParticipants in this group will receive one infusion of hMSC. Total participation is up to 12 weeks.
Primary Outcome Measure
Neuropsychiatric Inventory [ Time Frame: Up to 12 weeks. ]
Central Contacts
- Bernard Baumel, MD(305) 243-3100
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami Department of Neurology | Miami | Florida | 33136 | Bernard S. Baumel, MD (PRINCIPAL_INVESTIGATOR) |
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