Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.
NCT06781333 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2025-05-29
Summary
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.
Conditions
- Alzheimer Disease
- Agitation in Dementia
Interventions
- BIOLOGICAL
-
hMSC
Participants will come in person to receive one intravenous infusion of approximately 25 million cells up to 20 minutes.
Sponsors & Collaborators
-
Bernard (Barry) Baumel
lead OTHER
Principal Investigators
-
Bernard Baumel, MD · University of Miami
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 55 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-29
- Primary Completion
- 2026-06-15
- Completion
- 2026-06-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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