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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:2/7/2018
Start Date:June 2015
End Date:August 2019
Contact:Anthony Ting, PhD
Email:tting@athersys.com
Phone:216-431-9900

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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

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).


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
We found this trial at
11
sites
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Pittsburgh, PA
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Akron, OH
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Birmingham, AL
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Clearwater, FL
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Detroit, MI
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Gainesville, FL
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Huntsville, AL
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Los Angeles, CA
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Madison, WI
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Salt Lake City, UT
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Tampa, FL
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