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.
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
- Conditions the study is for
- Mild Cognitive Impairment, Early Alzheimer's Disease, AD-MCI
- 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
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.
United States1 site, 1 recruiting
- Recruiting
University of Miami Department of Neurology
Miami, Florida, 33136
Maria E. Puertas, CRC, (305) 243-3100, mep980@miami.edu
Bernard S Baumel, MD
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.
- Conditions
- Mild Cognitive Impairment, Early Alzheimer's Disease, AD-MCI
- 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 group | Role | What they receive |
|---|---|---|
| Mesenchymal Stem Cell Infusion | Experimental | Patients 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.
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)
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.
- First posted6 Apr 2026
- Study start15 May 2026
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bernard (Barry) Baumel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bernard (Barry) Baumel, University of Miami
- Investigators
- Bernard S. Baumel, MD, Principal investigator, University of Miami
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 9236950doi: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 35357079Alzheimer'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 31652984doi: 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 33353235doi: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 37213538Birks J. Cholinesterase inhibitors for Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD005593. doi: 10.1002/14651858.CD005593.
PubMed 16437532Staff, 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/.