Have you or your loved ones been diagnosed with heart attack?

You may be eligible to participate in a heart attack clinical trial.

Have you or your loved ones been diagnosed with heart attack? You may be eligible to participate in a heart attack clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Heart Attack Clinical Trial

NCT02277613 | Phase 2 | Interventional

Have you or your loved ones been diagnosed with heart attack?

You may be eligible to participate in a heart attack clinical trial.

Have you or your loved ones been diagnosed with heart attack? You may be eligible to participate in a heart attack clinical trial.

Terminated

Male & Female

18 - 85

Years old

This study has recruited 34 Participants

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).

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Details for the study

Brief Title

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

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

Brief Summary

This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility <br /> of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).

Treatments and/or Procedures

AMI multi stem 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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

Primary

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

Secondary

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

Secondary

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

Secondary

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

Study Criteria

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