Safety and Efficacy of Human Muse Cell-Based Product for Acute Myocardial Infarction in a First-in-Human Trial

Background: Because ST-elevation myocardial infarction (STEMI) extensively damages the heart, regenerative therapy with pluripotent stem cells such as multilineage-differentiating stress enduring (Muse) cells is required. Methods and Results: In a first-in-human study, 3 STEMI patients with a left ventricular ejection fraction (LVEF) <= 45% after successful percutaneous coronary intervention received intravenously 1.5x10(7) cells of a human Muse cell-based product, CL2020. The safety and efficacy on LVEF and wall motion score index (WMSI) were evaluated for 12 weeks. No adverse drug reaction was noted. LVEF and WMSI were markedly improved. Conclusions: The first-in-human intravenous administration of CL2020 was safe and markedly improved LV function in STEMI patients.