Status: Active, not recruiting
Keywords: Heart Faulure , Heart Stem Cell Therapy , Stem Cell , Ischemic Cardiomyopathy , Myocardial Infarct
IRB Number: 00057064
Specialty: Cardiology, Cardiology, Cardiothoracic Surgery, Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery
Sub Specialties: Interventional Cardiology, Coronary Revascularization, Heart Failure, Heart Stem Cell Therapy, Heart Failure
Early clinical data demonstrates that following a myocardial infarction (MI or heart attack) the acute loss of myocardial muscle cells and the low perfusion of oxygenated blood to that general area of the heart results in damage to the heart. The initial decrease in blood flow to the heart results in a series of events that leads to a decrease in cardiac function that can potentially exist long term. Standard of care treatment including surgery, angioplasty and/or stent placement can minimize the adverse affects of the heart attack and improve blood flow. However early research data has shown that cell therapy- in this study referred to as AMR-001, delivered during a specific window of time- which for this study is between day 4 -14 post MI, has shown that in addition to the standard of care treatment, the results from the stem cells' administration leads to neoangiogenesis which is the development of new blood vessels, thus leading to further improved blood flow to the damaged area of the heart and to cardiomyocyte (heart cells) preservation.
In this trial the primary objective is:
1. To determine safety and the effect of intracoronary infusion of AMR-001 on myocardial perfusion to patients who have had a ST segment elevation myocardial infarction (STEMI) and received a stent.
The secondary objectives of the study are:
1. To assess the effect of intra-coronary infusion of AMR-001 on MI size and cardiac function. Function will be assessed by measuring left ventricular ejection fraction (LVEF), end systolic and end diastolic volumes, regional myocardial strain and regional wall motion.
2. To assess Quality of Life meaures for change.
3. Comparison of the difference in individual and cumulative MACE (defined as cardiac mortality, hospitalization for worsening heart failure, or recurrent AMI) collected at 6 months, one year, 18 months, two years and three years.
The tertiary objective is:
1. To assess the relationship between the quantity and quality of CD34+ cells infused and perfusion (RTSS), infarct size, LV function and clinical outcomes.
2. Correlate baseline LVEF, baseline infarct size, baseline RTSS score, number of prior AMI, IRA site and time to stent placement with changes in perfusion, infarct size, LV function and clinical outcomes.