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Mild Cognitive ImpairmentPhase 2NCT07512362

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

A Phase 2 study testing human Mesenchymal Stem Cells in people with Mild Cognitive Impairment and Early Alzheimer's Disease, run by Bernard (Barry) Baumel at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 90 years
What is being tested?
human Mesenchymal Stem Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
15 May 2026to 15 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maria E. Puertas contact

(305) 243-3100

mep980@miami.edu

United States1 site, 1 recruiting

  • University of Miami Department of Neurology

    Miami, Florida, 33136

    Maria E. Puertas, CRC, (305) 243-3100, mep980@miami.edu

    Bernard S Baumel, MD

    Recruiting

Other trials in United States

About this study

Official 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.

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.

Being tested
human Mesenchymal Stem Cells
Keywords
Mild Cognitive Impairment, MCI, AD-MCI, Early Alzheimer's Disease
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • human Mesenchymal Stem CellsBiological

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

Study groups in NCT07512362
Study groupRoleWhat they receive
Mesenchymal Stem Cell InfusionExperimentalPatients will receive one infusion of 25 million of human mesenchymal stem cells in the vein.
Receives: Biological: human Mesenchymal Stem Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 16, Week 32, and Week 48

Secondary outcomes (1)

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

    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.

    Measured: Baseline, Week 16, Week 32, and Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2026
  2. Study start15 May 2026
  3. Primary completion15 Jun 2028 (estimated)
  4. Study completion15 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07512362
Sponsor's protocol ID
20251381
Status last verified
May 2026
First submitted
23 Mar 2026
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified IPD will be shared with researchers upon request following institutional guidelines and agreements in place. IPD will be shared after study publication.

Publications

  • 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.

    PubMed 9236950

  • doi:10.1177/1352458513475735

  • doi:10.1016/S1474-4422(15)70016-5

  • doi:10.1001/jamanetworkopen.2023.45175

  • doi:10.1016/S1474-4422(11)70305-2

  • doi:10.1212/WNL.0b013e3181b6bb95

  • 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.

    PubMed 35357079

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

  • 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.

    PubMed 31652984

  • doi: 10.3390/pharmaceutics11110552

  • 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.

    PubMed 33353235

  • doi:10.1038/ni.3102.

  • 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.

    PubMed 37213538

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

    PubMed 16437532

  • 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/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing human Mesenchymal Stem Cells in people with Mild Cognitive Impairment and Early Alzheimer's Disease, run by Bernard (Barry) Baumel at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria E. Puertas ((305) 243-3100, mep980@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog) (time frame: Baseline, Week 16, Week 32, and Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07512362, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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