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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Heart Attack, NSTEMI

Intervention / Treatment
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* Biological: AMI MultiStem cells
* Other: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMI MultiStem cells<br>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<br>* AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.<br>|
| Sham Comparator: Sham<br>Sham procedure using Micro-Infusion Catheter in coronary artery without injection. | Other: Sham<br>* Sham procedure using Micro-Infusion Catheter in coronary artery without injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events | To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects | 30 days | 
| To assess the effects of AMI MultiStem therapy on cardiac function | To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects | Day 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effects of AMI MultiStem therapy on cardiac function | To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects | Day 365 | 
| To assess the incidence of Major Adverse Cardiovascular Events (MACE) | To compare the incidence of MACE between AMI MultiStem therapy treated subjects and Sham treated subjects | Day 365 | 
| Incidence and severity of adverse events | To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects | Day 365 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cells