By Ashley Starkweather, B.S. and Asher Kimchi M.D.

FRANKFURT, GERMANY – The one year follow-up results of the Transplantation of Progenitor Cells And Regeneration Enhancement in Acute Myocardial Infarction (TOPCARE-AMI) trial show significant enhancement of functional regeneration in patients who sustained an acute myocardial infarction.

These one-year results of the trial were published by Volker Schächinger M.D., et al, in the Journal of the American College of Cardiology. The TOPCARE-AMI trial investigated safety, feasibility, and potential effects on parameters of myocardial function of intracoronary infusion of either circulating progenitor cells (CPC) or bone marrow-derived progenitor cells (BPC) in patients with acute myocardial infarction.

A total of 59 patients with AMI were randomly assigned to receive either CPC or BMC into the infarct artery at 4.9 ± 1.5 days after acute myocardial infarction.

Intracoronary progenitor cell application did not incur any measurable ischemic myocardial damage, but one patient experienced distal embolization before cell therapy. During hospital follow-up, one patient in each cell group developed myocardial infarction; one of these patients died of cardiogenic shock. No further cardiovascular events, including ventricular arrhythmias or syncope, occurred during one-year follow-up. By quantitative LV angiography at four months, LV ejection fraction significantly increased and end-systolic volumes significantly decreased, without differences between the two cell groups. Contrast-enhanced magnetic resonance imaging after one year revealed an increased ejection fraction, reduced infarct size, and absence of reactive hypertrophy, suggesting functional regeneration of the infarcted ventricles.

Intracoronary infusion of progenitor cells (either BMC or CPC) is safe and feasible in patients after acute myocardial infarction successfully revascularized by stent implantation. Both the excellent safety profile and the observed favorable effects on LV remodeling provide the rationale for larger randomized double-blind trials.