Ready-To-Use Investigational Stem Cells in Patients with recent Acute Myocardial Infarction

Abstract

AbstractBACKGROUNDCardiovascular diseases are a major health concern, and stem cell therapy holds promise as a potential treatment. However, obtaining stem cells from patients who are already ill poses challenges, as does limited access to specialized laboratories. We aimed to assess the safety and preliminary effectiveness of a read-to-use investigational stem cell product, MiSaver, in patients with recent acute myocardial infarction (AMI).METHODSWe enrolled 10 participants with AMI and reduced left ventricular ejection fraction (LVEF ≤45%). Group A (n=5) received a low dosage of 0.5×107cells/kg, and Group B (n=5) received a high dosage of 1.6×107cells/kg of cells. Additionally, 20 control patients who received standard care were included for statistical analysis. The primary outcome was the occurrence of side effects or graft-versus-host disease (GVHD) associated with the stem cell treatment. Secondary outcomes included changes in LVEF.RESULTSDuring the 12-month follow-up period, no study-related adverse effects or GVHD were observed. Baseline LVEF values for Group A and Group B were 42.0% and 41.3%, respectively, increasing to 53.0% and 53.7% at 12 months. Furthermore, no signs or symptoms of graft-versus-host disease (GVHD) were reported. Significant improvements in LVEF were observed in non-morbidly obese treated patients (cases 1-9), with baseline values of 41.3% and 12-month values of 53.7%, compared to the control group with baseline and 12-month values of 42.35% and 47.5%, respectively (p<0.05).CONCLUSIONSThis trial demonstrated the safety and tolerability of MiSaver stem cells in patients with recent AMI. Preliminary evidence suggests efficacy in improving outcomes in non-morbidly obese participants.