Stem Cells plus monoclonal antibodies for mild cognitive impairment or early Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial evaluates the addition of a single infusion of human mesenchymal stem cells to ongoing treatment with FDA-approved monoclonal antibodies (such as lecanemab or donanemab) in adults aged 55–90 with Mild Cognitive Impairment or mild Alzheimer’s disease due to AD. Participants must have been on the antibody therapy for at least six months and meet specific cognitive and consent criteria, including a study partner to complete functional assessments. The study will monitor changes in cognitive function and daily living activities to determine if the stem cell infusion can stabilize decline beyond what the antibodies achieve alone. Primary outcomes focus on cognitive and functional measures over the trial period, with safety monitoring for adverse events related to the stem cell infusion. The study is based at the University of Miami and led by Bernard Baumel.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• University of Miami Department of Neurology
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Bernard S. Baumel, MD — University of Miami
• Study coordinator: Maria E. Puertas
• Email: mep980@miami.edu
• Phone: (305) 243-3100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.