Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.
Purpose
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.
Conditions
- Mild Cognitive Impairment
- Early Alzheimer's Disease
- AD-MCI
Eligibility
- Eligible Ages
- Between 55 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Mesenchymal Stem Cell Infusion |
Patients will receive one infusion of 25 million of human mesenchymal stem cells in the vein. |
|
Recruiting Locations
University of Miami Department of Neurology
Miami, Florida 33136
Miami, Florida 33136
More Details
- Status
- Recruiting
- Sponsor
- Bernard (Barry) Baumel