MiSaver – Cell-Based Therapy Following Acute Myocardial Infarction

Acute myocardial infarction (AMI) can cause permanent damage to the myocardium and subsequent impairment of left ventricular function. Although contemporary treatments such as percutaneous coronary intervention (PCI) and pharmacological therapy have substantially improved outcomes after AMI, some patients continue to have reduced left ventricular ejection fraction (LVEF), placing them at increased risk of heart failure and other adverse cardiovascular outcomes. Recovery of LVEF following myocardial infarction is therefore an important indicator of prognosis.

MiSaver® (NCT06353958) is being investigated as a cell-based therapy intended to support recovery of cardiac function following AMI. The clinical development program has evaluated the administration of allogeneic umbilical cord blood-derived stem cells shortly after myocardial infarction, alongside standard treatment for AMI.

The study aimed primarily to evaluate the safety and feasibility of intravenous MiSaver administration in patients following recent AMI. Safety was assessed through adverse events over a 12-month follow-up period. The study also explored preliminary efficacy by assessing changes in left ventricular function, particularly LVEF, from baseline to 12 months following treatment. This is being measured by both echo and CMR, with CMR providing additional assessment of serial changes in myocardial injury. CIRSA is the imaging core lab (ECHO and CMR) for this trial, being conducted in Taiwan and Australia.