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A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction (MI-NSTEMI)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277613
Recruitment Status : Terminated
First Posted : October 29, 2014
Last Update Posted : May 4, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Athersys, Inc

Study Description
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Brief Summary:
This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).

Condition or disease Intervention/treatment Phase
Heart Attack NSTEMI Biological: AMI MultiStem cells Other: Sham Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Prospective, Randomized, Double-blind, Sham-controlled, Parallel-group, Multi-center Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
Actual Study Start Date : December 2015
Actual Primary Completion Date : June 2019
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Experimental: AMI MultiStem cells
AMI MultiStem cells is a cell therapy medicinal product originating from adherent stem cells taken from the bone marrow of a non-related donor and expanded ex vivo.
 Biological: AMI MultiStem cells
AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.
Sham Comparator: Sham
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
 Other: Sham
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: 30 days ]
    To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects

  2. To assess the effects of AMI MultiStem therapy on cardiac function [ Time Frame: Day 120 ]
    To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects


Secondary Outcome Measures :
  1. To assess the effects of AMI MultiStem therapy on cardiac function [ Time Frame: Day 365 ]
    To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects

  2. To assess the incidence of Major Adverse Cardiovascular Events (MACE) [ Time Frame: Day 365 ]
    To compare the incidence of MACE between AMI MultiStem therapy treated subjects and Sham treated subjects

  3. Incidence and severity of adverse events [ Time Frame: Day 365 ]
    To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of either gender, 18-85 years of age, inclusive
  • Diagnosis of non-ST elevation myocardial infarction (NSTEMI)
  • Left Ventricular Ejection Fraction (LVEF) between ≥ 25 and ≤ 45%

Exclusion Criteria:

  • Previous Coronary Artery Bypass Graft (CABG)
  • Previous autologous, allogeneic bone marrow or peripheral stem cell transplant
  • Previous solid organ transplant
  • Anticipated need for additional planned coronary revascularization procedure(s)
  • Hemodynamic instability
  • Mechanical complications of the index acute myocardial infarction
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): NCT02277613


Locations
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United States, Alabama
Birmingham, Alabama, United States
Huntsville, Alabama, United States
United States, California
Los Angeles, California, United States
United States, Florida
Clearwater, Florida, United States
Gainesville, Florida, United States
Tampa, Florida, United States, 33614
United States, Michigan
Detroit, Michigan, United States
United States, Ohio
Akron, Ohio, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Athersys, Inc
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Marc Penn, MD Summa Health System
More Information
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Responsible Party: Athersys, Inc
ClinicalTrials.gov Identifier: NCT02277613    
Other Study ID Numbers: B02-02
1R44HL117572-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020
Keywords provided by Athersys, Inc:
stem cells
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases