HONYA Medical Co., Ltd.

Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.

Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.
Primary Endpoint:
The primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.
Secondary Outcomes:
Secondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups.

The objective of the present study is to establish the safety and efficacy of MiSaver® Stem Cell Treatment After a Heart Attack (Acute Myocardial Infarction)