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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal Stem Cell Infusion | Experimental | Patients will receive one infusion of 25 million of human mesenchymal stem cells in the vein. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human Mesenchymal Stem Cells | Biological | Patients eligible to participate will receive one infusion of 25 million cells administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria E. Puertas | Contact | (305) 243-3100 | mep980@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bernard S. Baumel, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Department of Neurology | Recruiting | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9236950 | Background | 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. | |
| 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 |
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De-identified IPD will be shared with researchers upon request following institutional guidelines and agreements in place. IPD will be shared after study publication.
Post study publication.
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.
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| Baseline, Week 16, Week 32, and Week 48 |
| Background | doi:10.1212/WNL.0b013e3181b6bb95 |
| 35357079 | 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. |
| Background | Alzheimer's Association 2024 Alzheimer's Disease Facts and Figures |
| 31652984 | 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. |
| Background | doi: 10.3390/pharmaceutics11110552 |
| 33353235 | 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. |
| Background | doi:10.1038/ni.3102. |
| 37213538 | 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. |
| 16437532 | Background | Birks J. Cholinesterase inhibitors for Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD005593. doi: 10.1002/14651858.CD005593. |
| 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 |
| 34567426 | 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. |
| 6496779 | 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. |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
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