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NCT Number: NCT07512362

Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.

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.

Recruiting

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Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami Department of Neurology

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Bernard S Baumel, MD

PRINCIPAL_INVESTIGATOR

Maria E. Puertas, CRC

CONTACT

[email protected]

(305) 243-3100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human Mesenchymal Stem Cells

Biological

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

Primary outcomes

  1. Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog)

    Time frame: Baseline, Week 16, Week 32, and Week 48

    The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-11) is a validated performance-based instrument used to assess the severity of cognitive impairment in individuals with Alzheimer's disease. The scale evaluates multiple cognitive domains, including memory, reasoning, language, orientation, ideational praxis, and constructional praxis. Spoken language, language comprehension, word-finding ability, and the ability to remember instructions are also assessed. Scores range from 0 to 70, with higher scores indicating greater cognitive impairment.

Secondary outcomes

  1. Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-MCI -ADL)

    Time frame: Baseline, Week 16, Week 32, and Week 48

    The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-MCI-ADL) is an 18-item caregiver-reported instrument assessing basic and instrumental daily activities. Total scores range from 0 to 57, with higher scores indicating greater functional independence.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria E. Puertas

CONTACT

[email protected]

(305) 243-3100

Sponsors and collaborators

Lead sponsor

Bernard (Barry) Baumel

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 6, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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