Recruiting
Phase 2

hMSCs with mAb

Sponsor:

Bernard (Barry) Baumel

Code:

NCT07512362

Conditions

Mild Cognitive Impairment

Early Alzheimer's Disease

AD-MCI

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

human Mesenchymal Stem Cells

Study Details

Brief summary:

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

Study ID

NCT07512362

Start date

May 15, 2026

Status verified date

May, 2026

Completion date

Jun 15, 2028

Anticipated

Primary completion date

Jun 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mesenchymal Stem Cell Infusion

Patients will receive one infusion of 25 million of human mesenchymal stem cells in the vein.

Interventions

human Mesenchymal Stem Cells

Patients eligible to participate will receive one infusion of 25 million cells administered intravenously.

Primary outcome measure

  • Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog) [ Time Frame: Baseline, Week 16, Week 32, and Week 48 ]

Central Contacts and Locations

Central contacts

Maria E. Puertas

(305) 243-3100mep980@miami.edu

Locations

University of Miami Department of Neurology

Recruiting

Miami, Florida, United States, 33136

Contacts

Maria E. Puertas, CRC

(305) 243-3100mep980@miami.edu

Principal Investigator:

Bernard S Baumel, MD

More Information

Sponsor

Bernard (Barry) Baumel

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • Mild Cognitive Impairment
  • MCI
  • AD-MCI
  • Early Alzheimer's Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bernard (Barry) Baumel on 2026-05-28.