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

Phase 2TerminatedNCT02277613

Healios K.K.34 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Attack NSTEMI

Interventions

AMI MultiStem cellsBIOLOGICAL

AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.

ShamOTHER

Sham procedure using Micro-Infusion Catheter in coronary artery without injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (11)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Huntsville, Alabama, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Clearwater, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Day 120

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Day 365

Data from ClinicalTrials.gov

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