About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- human Mesenchymal Stem Cells
Treatment groups
Sponsors and collaborators
Bernard (Barry) Baumel
Lead sponsor
University of Miami
Sponsor institution