Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT02833792|
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : October 28, 2022
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To assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem cells (hMSCs) manufactured by Stemedica versus placebo administered intravenously to subjects with mild to moderate dementia due to Alzheimer's disease.
To assess the preliminary efficacy of hMSCs versus placebo in subjects with Alzheimer's-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Dementia||Drug: Human Mesenchymal Stem Cells and Lactated Riunger's Solution Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Phase IIa Study of Allogeneic Human Mesenchymal Stem Cells in Subjects With Mild to Moderate Dementia Due to Alzheimer's Disease|
|Actual Study Start Date :||June 1, 2016|
|Estimated Primary Completion Date :||July 30, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Stem Cells
Drug: Human Mesenchymal Stem Cells and Lactated Riunger's Solution
Placebo Comparator: Placebo
Lactated Ringer's Solution
- Safety of aMBMC administration [ Time Frame: 18 months ]Number of patients with adverse events will be reported
- Efficacy of aMBMC administration [ Time Frame: 18 months ]Changes is scores relatively to baseline using NIHSS system will be reported for each patient
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|Ages Eligible for Study:||55 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Males or females between 55-80 years of age.
- Diagnosed with mild to moderate dementia for at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative
- Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) Alzheimer's criteria.
- MMSE between 12-24 (inclusive) at time of enrollment.
- Amyloid-positive florbetapir PET scan.
- Prior treatment with stem cells.
- History of intracranial, subdural, or subarachnoid hemorrhage.
- Subjects with baseline brain MRI showing more than four (4) cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), and/or one (1) or more areas of superficial siderosis, and/or evidence of a prior macrohemorrhage. MRI must include fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences.
- History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma.
- History of seizure disorder.
- Diagnosis of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL).
- History of cerebral neoplasm.
- Myocardial infarction within six months of enrollment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833792
|Contact: Lev Verkh, PhDemail@example.com|
|Contact: Marcie Frank, RN BSNfirstname.lastname@example.org|
|United States, California|
|John Wayne Cancer Institute @ Providence St. John's Health Center||Recruiting|
|Santa Monica, California, United States, 90404|
|Contact: Mini Gill, RN BSN 310-582-7437 Jaya.Gill@providence.org|
|Principal Investigator: Santosh Kesari, MD, PhD|
|Study Chair:||Lev Verkh, PhD||Stemedica Cell Technologies|
|Responsible Party:||Stemedica Cell Technologies, Inc.|
|Other Study ID Numbers:||
|First Posted:||July 14, 2016 Key Record Dates|
|Last Update Posted:||October 28, 2022|
|Last Verified:||October 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Central Nervous System Diseases
Nervous System Diseases