NCT07512362RecruitingPhase 2
Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.
A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to Patients Treated With Anti-Amyloid Monoclonal Antibodies Who Are Suffering From Mild Cognitive Impairment or Mild Alzheimer's Disease.
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 23 Mar 2026
- Start date
- 15 May 2026
- Primary completion date
- 15 Jun 2028
- Lead sponsor
- Bernard (Barry) Baumel
- Diseases
- Alzheimer disease
- NCT number
- NCT07512362
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- From 15 May 2026 to the primary completion date, 15 Jun 2028
- 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 MI 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, 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.
- 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. Patients with controlled depression are allowed to participate.
- Inability to independently provide informed consent is considered exclusionary per protocol requirements
- Be premenopausal
Who the study is looking for
- 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.
Age in the registry: 55 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Department of Neurology Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.