Actively Recruiting
Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.
Led by Bernard (Barry) Baumel · Updated on 2025-05-29
8
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 55 to 90 years at the time of consent
- Diagnosis of probable Alzheimer's disease based on established criteria
- Previous brain imaging consistent with Alzheimer's disease
- Behavioral symptoms including delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, abnormal motor behavior, sleep or eating disorders
- Behavioral symptoms started at least 4 weeks before screening
- Treatment with antipsychotic medication for at least 4 weeks before the infusion
- Consent provided by patient or legally authorized representative
- Have a family member or friend who frequently interacts with the patient and can report on behavior
You will not qualify if you...
- Diagnosis of dementia other than Alzheimer's disease
- Severe depression (controlled depression allowed)
- Recent substance abuse
- History of bleeding disorders, HIV, Hepatitis B or C
- History of malignancies within 3 years except certain treated skin and in situ cancers
- Uncontrolled medical conditions such as hypertension, diabetes, unstable angina, or recent heart attack
- Receiving experimental Alzheimer's treatments or enrolled in trials within last 3 months
- Transplant recipient or other active medical conditions that may affect safety or study completion
- Premenopausal women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami Department of Neurology
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
B
Bernard Baumel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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