Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.

A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to the Treatment of Patients Suffering Agitation/Aggression or Other Behavioral Abnormalities From Alzheimer's Disease.

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Agitation in Dementia
• Intervention / Treatment: Biological: hMSC

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bernard Baumel, MD; Phone Number: (305) 243-3100; Email: mep980@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Department of Neurology
      • Contact: Carmen Perez; Phone Number: (305) 243-0184; Email: c.perez71@miami.edu
      • Principal Investigator: Bernard S. Baumel, MD
      • Contact: Maria E. Puertas; Phone Number: (305) 243-0184; Email: mep980@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults 55-90 years at the time of signing consent
• A diagnosis of probable Alzheimer disease (AD), defined by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
• Previous computed tomography or magnetic resonance imaging scan of the brain with findings consistent with a diagnosis of Alzheimer disease
• A diagnosis of behavioral symptoms that include any of the following: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and nighttime behavior disorders and appetite and eating disorders
• Onset of behavioral symptoms at least 4 weeks prior to screening.
• Treatment with antipsychotic medication for at least 4 weeks prior to the hMSC infusion.
• Patients unable to consent should have a Legally Authorized Representative or Proxy to provide consent on their behalf.
• Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and able to answer questions about the participant's behavior.

Exclusion Criteria:

• Dementia other than AD
• Patient with severe depression. Patient with controlled depression is allowed to participate.
• Recent history of substance abuse
• History of bleeding disorders, HIV, Hepatitis C Virus or Hepatitis B Virus
• Recent history (within 3 years) of malignancies, except for treated basal cell, squamous carcinoma or melanoma in situ, prostate in situ, cervical carcinoma in situ.
• Uncontrolled medical conditions (hypertension, diabetes, unstable angina or Myocardial Infarction within 1 year prior to screening)
• History of bleeding disorder
• Currently receiving (or received within four weeks of screening) experimental agents for the treatment of Alzheimer's Disease or enrolled in clinical trials in the prior 3 months.
• Be a transplant recipient or in any other active medical condition than in the opinion of the investigator may compromise the safety or compliance of the patient or preclude successful completion of the study
• Be premenopausal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hMSC group; Participants in this group will receive one infusion of hMSC. Total participation is up to 12 weeks.	Biological: hMSC; Participants will come in person to receive one intravenous infusion of approximately 25 million cells up to 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychiatric Inventory	Score ranges from 0-12, higher scores indicate a worse psychiatric outcome	Up to 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in antipsychotic medications dosage	Will be measured in milligrams	Baseline to 12 weeks
Change in number of antipsychotic medications	Will be measured in number of antipsychotic medications	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Bernard (Barry) Baumel
• Investigators: Principal Investigator: Bernard Baumel, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: behavior; agitation; aggression
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurobehavioral Manifestations; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Dyskinesias; Psychomotor Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Social Behavior; Aberrant Motor Behavior in Dementia; Alzheimer Disease; Psychomotor Agitation; Aggression; Behavior
• Other Study ID Numbers: 20240984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No