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Trial record 1 of 6 for:    stemedica
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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 : April 9, 2019
Sponsor:
Collaborator:
Stemedica International SA
Information provided by (Responsible Party):
Stemedica Cell Technologies, Inc.

Tracking Information
First Submitted Date  ICMJE June 20, 2016
First Posted Date  ICMJE July 14, 2016
Last Update Posted Date April 9, 2019
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
Safety of aMBMC administration [ Time Frame: 18 months ]
Number of patients with adverse events will be reported
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
Safety [ Time Frame: 18 months ]
Safety assessments measured by adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
Efficacy of aMBMC administration [ Time Frame: 18 months ]
Changes is scores relatively to baseline using NIHSS system will be reported for each patient
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
Efficacy [ Time Frame: 18 months ]
Efficacy assessments measures by neurological examinations
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease
Official Title  ICMJE A Phase IIa Study of Allogeneic Human Mesenchymal Stem Cells in Subjects With Mild to Moderate Dementia Due to Alzheimer's Disease
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Dementia
Intervention  ICMJE
  • Drug: Human Mesenchymal Stem Cells and Lactated Riunger's Solution
    Intravenous administration
  • Other: Placebo
    Intravenous administration
Study Arms  ICMJE
  • Experimental: Stem Cells
    Stem cells
    Intervention: Drug: Human Mesenchymal Stem Cells and Lactated Riunger's Solution
  • Placebo Comparator: Placebo
    Lactated Ringer's Solution
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mini Gill, RN BSN 310.582.7437 Jaya.Gill@providence.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02833792
Other Study ID Numbers  ICMJE STEM105-M-AD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stemedica Cell Technologies, Inc.
Study Sponsor  ICMJE Stemedica Cell Technologies, Inc.
Collaborators  ICMJE Stemedica International SA
Investigators  ICMJE
Study Chair: Lev Verkh, PhD Stemedica Cell Technologies
PRS Account Stemedica Cell Technologies, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP