Acute Myocardial Infarct and Chronic Heart Failure

Acute Myocardial Infarct and Chronic Heart Failure

Successful treatment of acute myocardial infarction (AMI) has contributed to a Chronic Heart Failure (CHF) epidemic with 26 million patients worldwide. CHF post-MI is a terminal disease with an annual mortality rate of ~18% after the first episode, for which no curative treatment exists with the exception of heart transplantation. Myocardial repair seems to be the only feasible treatment to address the post-acute phase of the disease and prevent the onset of CHF.

AlloCSC-01

This cellular product consists of adult allogeneic cardiac stem cells isolated from the right atrial appendages of donors, and expanded in vitro. Pre-clinical data has shown evidence of the strong cardio-protective and immune-regulatory activity of AlloCSC-01. In vivo studies suggest that AlloCSC-01 has cardio-reparative potential by activating endogenous regenerative pathways and by promoting the formation of new cardiac tissue. In addition, AlloCSC-01 has displayed a strong tropism for the heart enabling a high retention of cells in the myocardium after intracoronary administration.

The ongoing randomised, placebo-controlled, multicentre Phase II study in acute myocardial infarction is being conducted in 9 hospitals in Belgium and Spain. After a successful open-label dose escalation phase of 6 patients, the clinical trial has recruited  49 additional patients randomised 2:1 to receive either AlloCSC-01 or placebo by intracoronary injection 5 to 8 days after the myocardial infarction. The primary endpoint is all-cause mortality and MACE (Major Adverse Cardiac Events) at 30 days. Secondary endpoints include efficacy MRI parameters (evolution of infarct size and evolution of biomechanical parameters), clinical parameters (including the 6 minute walking test and the New York Heart Association scale) and all-cause mortality and MACE, all measured at 6 and 12 months. Results are expected in the first half of 2017.

According to Datamonitor(1) more than 1,9 million acute myocardial infarctions (AMI) occur annually in the United States of America and in the European Union. These AMI cases are mostly treated by PCI(2) and stent implantation. In 2010, the American Heart Association estimated that the direct and indirect cost of heart failure in the United States was $39 billion, half of which was related to repeated hospitalizations, and by 2030 the total cost of heart failure in the United States is projected to increase to $70 billion.

(1) Datamonitor: Stakeholder Insight: Acute coronary syndromes, DMHC2347, 2007

(2) Percutaneous Coronary Intervention

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