Recruiting

Phase 2

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

Sponsor:

Bernard (Barry) Baumel

Code:

NCT06781333

Conditions

Alzheimer Disease

Agitation in Dementia

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

hMSC

Study Details

Brief 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

Study ID

NCT06781333

Start date

Apr 29, 2025

Status verified date

May, 2026

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: hMSC group

Participants in this group will receive one infusion of hMSC. Total participation is up to 12 weeks.

Interventions

hMSC

Participants will come in person to receive one intravenous infusion of approximately 25 million cells up to 20 minutes.

Primary outcome measure

Neuropsychiatric Inventory [ Time Frame: Up to 12 weeks. ]

Central Contacts and Locations

Central contacts

Bernard Baumel, MD

(305) 243-3100 mep980@miami.edu

Locations

University of Miami Department of Neurology

Recruiting

Miami, Florida, United States, 33136

Contacts

Maria E. Puertas

(305) 243-0184 mep980@miami.edu

Carmen Perez

(305) 243-0184 c.perez71@miami.edu

Principal Investigator:

Bernard S. Baumel, MD

More Information

Sponsor

Bernard (Barry) Baumel

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

aggression
behavior
agitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bernard (Barry) Baumel on 2026-05-28.