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

NCT07512362 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 20251381
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, Week 16, Week 32, and Week 48

Secondary Outcomes (1)

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

  Baseline, Week 16, Week 32, and Week 48

Study Arms (1)

Mesenchymal Stem Cell Infusion

EXPERIMENTAL

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

Biological: human Mesenchymal Stem Cells

Interventions

human Mesenchymal Stem Cells BIOLOGICAL

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

Mesenchymal Stem Cell Infusion

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Dementia other than AD
• Patient with severe depression. Patients with controlled depression are allowed to participate.
• 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

Sponsors & Collaborators

• Bernard (Barry) Baumel: lead

Study Sites (1)

University of Miami Department of Neurology

Miami, Florida, 33136, United States

RECRUITING

Related Publications (18)

• Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, Ferris S. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S33-9.

  PMID: 9236950 BACKGROUND

• doi:10.1177/1352458513475735

  BACKGROUND

• doi:10.1016/S1474-4422(15)70016-5

  BACKGROUND

• doi:10.1001/jamanetworkopen.2023.45175

  BACKGROUND

• doi:10.1016/S1474-4422(11)70305-2

  BACKGROUND

• doi:10.1212/WNL.0b013e3181b6bb95

  BACKGROUND

• Brody M, Agronin M, Herskowitz BJ, Bookheimer SY, Small GW, Hitchinson B, Ramdas K, Wishard T, McInerney KF, Vellas B, Sierra F, Jiang Z, Mcclain-Moss L, Perez C, Fuquay A, Rodriguez S, Hare JM, Oliva AA Jr, Baumel B. Results and insights from a phase I clinical trial of Lomecel-B for Alzheimer's disease. Alzheimers Dement. 2023 Jan;19(1):261-273. doi: 10.1002/alz.12651. Epub 2022 Mar 31.

  PMID: 35357079 BACKGROUND

• Alzheimer's Association 2024 Alzheimer's Disease Facts and Figures

  BACKGROUND

• Guadix JA, Lopez-Beas J, Clares B, Soriano-Ruiz JL, Zugaza JL, Galvez-Martin P. Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges. Pharmaceutics. 2019 Oct 24;11(11):552. doi: 10.3390/pharmaceutics11110552.

  PMID: 31652984 BACKGROUND

• doi: 10.3390/pharmaceutics11110552

  BACKGROUND

• Salari V, Mengoni F, Del Gallo F, Bertini G, Fabene PF. The Anti-Inflammatory Properties of Mesenchymal Stem Cells in Epilepsy: Possible Treatments and Future Perspectives. Int J Mol Sci. 2020 Dec 18;21(24):9683. doi: 10.3390/ijms21249683.

  PMID: 33353235 BACKGROUND

• doi:10.1038/ni.3102.

  BACKGROUND

• Qiao Y, Chi Y, Zhang Q, Ma Y. Safety and efficacy of lecanemab for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials. Front Aging Neurosci. 2023 May 5;15:1169499. doi: 10.3389/fnagi.2023.1169499. eCollection 2023.

  PMID: 37213538 BACKGROUND

• Birks J. Cholinesterase inhibitors for Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD005593. doi: 10.1002/14651858.CD005593.

  PMID: 16437532 BACKGROUND

• Staff, BrightFocus Editorial. "5 Things to Know about the New Alzheimer's Drug, KISUNLA." BrightFocus Foundation, 23 Jan. 2025, www.brightfocus.org/resource/alzheimers-article-5-things-know-about-new-alzheimers-drug-kisunla/.

  BACKGROUND

• doi:10.1001/jama.2023.25768

  BACKGROUND

• Skok M. Mesenchymal stem cells as a potential therapeutic tool to cure cognitive impairment caused by neuroinflammation. World J Stem Cells. 2021 Aug 26;13(8):1072-1083. doi: 10.4252/wjsc.v13.i8.1072.

  PMID: 34567426 BACKGROUND

• Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.

  PMID: 6496779 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Bernard S. Baumel, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria E. Puertas

CONTACT

(305) 243-3100; mep980@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Clinical Neurology

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 6, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Post study publication.
• Access Criteria: Qualified researchers will have access to de-identified study data upon request to the study Principal Investigator (Dr. Barry Baumel). Results of cognitive and QOL scales will be provided via email upon request.

Locations

US (1)