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Human Mesenchymal Stem Cells & Monoclonal Antibodies for Mild Cognitive Impairment or Early Alzheimer's Disease

This study is looking at whether adding a single infusion of human Mesenchymal Stem Cells (hMSCs) can help stabilize memory and thinking decline in people with mild cognitive impairment or early Alzheimer's disease. You would need to be between 55 and 90 years old and already receiving treatment with an FDA-approved monoclonal antibody like Leqembi (lecanemab) or Kisunla (donanemab) for at least six months. The study will measure changes in your cognitive (thinking and memory) abilities using a test called ADAS-Cog over 48 weeks to see if the hMSCs help. The current status of this study is unclear, and it plans to enroll 10 participants.

Study design
This is an interventional study. It plans to enroll 10 participants.
What's involved
You would receive one intravenous infusion of 25 million human Mesenchymal Stem Cells. Your cognitive abilities would be measured at baseline, week 16, week 32, and week 48.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 48 weeks after the infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07512362

Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.

Recruiting
PHASE2Ages 55–90InterventionalTreatment
Bernard (Barry) Baumel
~10 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:human Mesenchymal Stem Cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog)
Measured over Baseline, Week 16, Week 32, and Week 48

Conditions

Mild Cognitive Impairment
Early Alzheimer's Disease
AD-MCI

Explore related trials

Alzheimer's DiseaseMild cognitive disorder

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Bernard S. Baumel, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Maria E. Puertas
[email protected]
(305) 243-3100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults 55-90 years at the time of signing consent
Patients diagnosed with Mild Cognitive Impairment or mild Dementia due to Alzheimer disease, receiving treatment with an FDA approved monoclonal antibody (Leqembi/Lecanemab or Kisunla/Donanemab) for at least 6 months prior to the infusion visit.
MMSE score 20-26.
Patients must be able to consent.
Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and is able to answer questions about the participant's daily activities to complete the ADCS-MCI-ADL. Completing this scale is required to assess the impact of the study intervention on cognitive function and daily living skills in this patient population. Having a study partner is a requirement of this study.

Exclusion

Dementia other than AD
Patient with severe depression. Patients with controlled depression are allowed to participate.
Inability to independently provide informed consent is considered exclusionary per protocol requirements
Recent history of substance abuse
History of bleeding disorders, HIV, HCV or HBV
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 MI 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

What this trial measures

  • Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog)Baseline, Week 16, Week 32, and Week 48

    The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-11) is a validated performance-based instrument used to assess the severity of cognitive impairment in individuals with Alzheimer's disease. The scale evaluates multiple cognitive domains, including memory, reasoning, language, orientation, ideational praxis, and constructional praxis. Spoken language, language comprehension, word-finding ability, and the ability to remember instructions are also assessed. Scores range from 0 to 70, with higher scores indicating greater cognitive impairment.