A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
NCT ID: NCT02277613
Last Updated: 2021-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
34 participants
INTERVENTIONAL
2015-12-31
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
AMI MultiStem cells
AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.
Sham
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
Sham
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
Interventions
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AMI MultiStem cells
AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.
Sham
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of non-ST elevation myocardial infarction (NSTEMI)
* Left Ventricular Ejection Fraction (LVEF) between ≥ 25 and ≤ 45%
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Healios K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Penn, MD
Role: PRINCIPAL_INVESTIGATOR
Summa Health System
Locations
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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Los Angeles, California, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
Tampa, Florida, United States
Detroit, Michigan, United States
Akron, Ohio, United States
Pittsburgh, Pennsylvania, United States
Salt Lake City, Utah, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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B02-02
Identifier Type: -
Identifier Source: org_study_id
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