Fact CheckerSign in

NCT06781333RecruitingPhase 2

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.

Source: ClinicalTrials.gov · Last updated 28 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
8 (estimated)
First submitted
13 Jan 2025
Start date
29 Apr 2025
Primary completion date
15 Dec 2027
Lead sponsor
Bernard (Barry) Baumel
NCT number
NCT06781333

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 8
  • From 29 Apr 2025 to the primary completion date, 15 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Uncontrolled medical conditions (hypertension, diabetes, unstable angina or Myocardial Infarction within 1 year prior to screening)
  • 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.

Other illness

  • Dementia other than AD
  • 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.
  • History of bleeding disorder
  • 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

Other

  • Patient with severe depression. Patient with controlled depression is allowed to participate.
  • Be premenopausal

Who the study is looking for

  • 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.

Age in the registry: 55 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Miami Department of Neurology
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.