Ready-To-Use Investigational Stem Cells, MiSaver, in Patients with Recent Acute Myocardial Infarction, 1 year follow up from a Phase 1 Safety Study

Abstract

AbstractObjectivesThe aim of this study was to investigate the safety of MiSaver stem cells and their preliminary efficacy in improving left ventricular ejection function and functional activity in patients with acute myocardial infarction (AMI)BackgroundCardiovascular diseases (CVDs) are the leading cause of death globally. In 2019, an estimated 17.9 million people died from CVDs, accounting for 32% of all global deaths. Among these deaths, 85% were due to heart attacks and strokes.Left ventricular ejection fraction (LVEF) recovery after myocardial infarction (MI) is an important prognostic indicator, and patients who do not recover LVEF after MI are at high risk of sudden cardiac arrest events and death.Stem cell therapy holds promise for cardiovascular diseases, offering regenerative potential through cell differentiation. However, limited access exists for clinicians and patients. This study investigates the safety and efficacy of MiSaver (Myocardial Infarction Functional Saver), a prefabricated stem cell investigational product, in recent AMI patients. Findings contribute to advancing stem cell treatments, improving accessibility and patient outcomes.MethodsPatients who were admitted for AMI within 7 days and had reduced LVEF (.45%) were eligible for the study. MiSaver were matched for blood group and administered in participants in cohorts of five, each receiving escalating dosages (0.5×10^7, 1.6×10^7, and 5.0×10^7 cells/kg, respectively). Patients were assessed for symptoms of graft-versus-host disease (GVHD) and treatment-related adverse events (AE). LVEF measured by echocardiographic on admission, at 6 months, and at 12 months after treatment. Patients functional activity status evalution ( using the New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) classification systems.ResultsOut of the initially planned 15 participants, eleven were enrolled in the study. The trial was halted prematurely due to challenges associated with the COVID-19 pandemic and impractical transportation logistics. Patients received MiSaver infusions within 2-5 days post-AMI onset. During the 12-month follow-up period, no study-related adverse events or signs of graft-versus-host disease were reported. At 12 months post-treatment, both the low and middle dose groups, as well as participant 11, showed improved LVEF, accompanied by enhanced Canadian Cardiovascular Society (CCS) class grades compared to baseline.ConclusionThe intravenous infusion of MiSaver stem cells in AMI patients demonstrated safety and tolerability for low and middle dosage groups. The study provides promising insights into the potential of stem cells therapy in improving left ventricular function following AMI. However, further research with larger cohorts and a controlled placebo is warranted to confirm these findings and address limitations encountered during this trial.