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Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02833792
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : October 28, 2022
Sponsor:
Collaborator:
Stemedica International SA
Information provided by (Responsible Party):
Stemedica Cell Technologies, Inc.

Study Description
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Brief Summary:

STUDY OBJECTIVES

Primary:

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.

Secondary:

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

Detailed Description:
This is a Phase IIa multi-center, randomized, single-blind, placebo-controlled, crossover study in subjects with mild to moderate dementia due to Alzheimer's disease. Only the subject and their caregiver will be blinded to the study treatment. The study will consist of two cohorts of subjects (20 subjects per cohort), randomized in a 1:1 allocation to receive active study drug or placebo. Cohort 1 will receive a single intravenous dose of hMSCs of 1.5 million cells per kilogram body weight on their Study Day 1, and Cohort 2 will receive equal volume of Lactated Ringer's Solution on their Study Day 1. At the six-month time point for each subject after their first infusion, Cohort 1 will receive a single intravenous dose of Lactated Ringer's Solution and Cohort 2 will receive a single intravenous dose of hMSCs at 1.5 million cells per kilogram of the subject's body weight. Approximately 40 subjects will be enrolled in this study. An independent Data and Safety Monitoring Board will conduct periodic safety reviews.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem Cells
Stem cells
 Drug: Human Mesenchymal Stem Cells and Lactated Riunger's Solution
Intravenous administration
Placebo Comparator: Placebo
Lactated Ringer's Solution
 Other: Placebo
Intravenous administration


Outcome Measures
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Primary Outcome Measures :
  1. Safety of aMBMC administration [ Time Frame: 18 months ]
    Number of patients with adverse events will be reported


Secondary Outcome Measures :
  1. Efficacy of aMBMC administration [ Time Frame: 18 months ]
    Changes is scores relatively to baseline using NIHSS system will be reported for each patient


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Males or females between 55-80 years of age.
  2. Diagnosed with mild to moderate dementia for at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative
  3. Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) Alzheimer's criteria.
  4. MMSE between 12-24 (inclusive) at time of enrollment.
  5. Amyloid-positive florbetapir PET scan.

Exclusion Criteria:

  1. Prior treatment with stem cells.
  2. History of intracranial, subdural, or subarachnoid hemorrhage.
  3. 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.
  4. History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma.
  5. History of seizure disorder.
  6. Diagnosis of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL).
  7. History of cerebral neoplasm.
  8. Myocardial infarction within six months of enrollment.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Lev Verkh, PhD 858-658-0910 lverkh@stemedica.com
Contact: Marcie Frank, RN BSN 858-658-0910 mfrank@stemedica.com

Locations
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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         
Sponsors and Collaborators
Stemedica Cell Technologies, Inc.
Stemedica International SA
Investigators
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Study Chair: Lev Verkh, PhD Stemedica Cell Technologies
More Information
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Additional Information:

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Responsible Party: Stemedica Cell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02833792    
Other Study ID Numbers: STEM105-M-AD
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
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders