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) Change from baseline to 6 months in myocardial perfusion (RTSS) measured quantitatively by gated single photon emission computed tomography myocardial perfusion imaging (gated SPECT MPI).
2) Safety of bone marrow procurement and AMR-001 cell infusion as measured by occurrence of SAEs and MACE.
The secondary objectives of the study are:
1) Change from baseline to 6 months in LVEF measured by CMR (when paired CMR data are not evaluable LVEF from SPECT-MPI will be imputed).
2) Preservation of left ventricular ejection fraction at 6 months post randomization. Preservation of LVEF is a binary endpoint defined as no decrease on CMR in LVEF of greater than 2% or in patients unable to complete their 6 month CMR then no decrease on SPECT of greater than 5%.
3) Time to individual and composite MACE events (defined as cardiovascular mortality, hospitalization for heart failure recurrent AMI or coronary revascularization), and cumulative number of events listed herein, with each analyzed with a minimum of 6 months of follow-up
for the primary analysis and subsequently for the confirmatory analysis, with a maximum of 3 years
4) Change in quality of life from baseline to 6 and 12 months evaluated by the Overall Summary Score of
the Kansas City Cardiomyopathy Questionnaire (KCCQ).
5) Change in QOL from baseline to 6 and 12 months in the Angina and QOL domains from the SAQ.
The tertiary objective is:
There will be a number of tertiary analyses using already defined endpoints and additional ones as well. The endpoints for analysis will be defined in detail in the SAP.