NCT07512362 · Bernard (Barry) Baumel
Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.
What this study is about
The purpose of this study is to test if adding one infusion of (Human Mesenchymal Stem Cells) hMSCs to the treatment with the usual treatment (SOC) monoclonal antibodies (mAb) will stabilize the rate of cognitive and functional decline associated with mild Alzheimer's Disease.
View original scientific description
The purpose of this study is to test if adding one infusion of (Human Mesenchymal Stem Cells) hMSCs to the treatment with standard of care (SOC) monoclonal antibodies (mAb) will stabilize the rate of cognitive and functional decline associated with mild Alzheimer's Disease.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Miami, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations