A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction (MI-NSTEMI)
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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
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Condition or disease | Intervention/treatment | Phase |
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Heart Attack NSTEMI | Biological: AMI MultiStem cells Other: Sham | Phase 2 |
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 |

Arm | Intervention/treatment |
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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.
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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.
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Other: Sham
Sham procedure using Micro-Infusion Catheter in coronary artery without injection. |
- 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
- 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
- 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
- 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
- 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

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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 |
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

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
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 |
Principal Investigator: | Marc Penn, MD | Summa Health System |
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 |
stem cells |
Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |