A clinical study to assess the safety and efficacy of stem cell in patients with Myocardial Infarction

INTERVENTION: Intervention1: Ex vivo cultured adult allogenic MSCs: Single IV dose of allogenic MSCs (2 million cells per Kg body weight suspended in Plasmalyte‐A) infused within a period of 30 to 45 min Control Intervention1: Plasmalyte‐A: Single IV dose of Plasmalyte‐A infused within a period of 30 to 45 min CONDITION: ST elevated acute myocardial infarction (STEMI) PRIMARY OUTCOME: The primary safety end points are: ; 1.The type of AE(s),number of AE(s) and proportion of patients with AE(s)2.Assessment of clinical laboratory parameters ; 3.Assessment of vital signs ; 4.Assessment of electrocardiogram (ECG) parameters ; The primary efficacy endpoint is: ; 1.Improvement in left ventricular ejection fraction (LVEF), end systolic volume, and end diastolic volume assessed by echocardiography at the end of 6 months.‐‐‐‐‐‐Timepoint: All primary end points are assessed at the end of 6 months. Subjects are followed for safety reasons for uptil 2 years SECONDARY OUTCOME: Secondary outcome variables: ; The secondary efficacy endpoints are: ; 1.Assessment of regional myocardial perfusion by SPECT ; 2.Assessment of percentage change in infarct size by MRI ; 3.Assessment of regional myocardial function by MRI‐‐‐‐‐‐Timepoint: Assessed at the end of 6months INCLUSION CRITERIA: a) Patients with STEMI aged between 20 and 70 years, either males or females with non‐child bearing potential, after 2 days of successful PCI. b) Patient has global left ventricular systolic dysfunction with an ejection fraction of <50% and >30%. c) ECG with sign of acute anterior MI with ST‐elevation ≥ 2 mm in at least 2 of the following leads I, AVL, V1‐V6, or ECG with sign of acute inferoposterior MI with ST elevation ≥1 mm on all of the following leads‐ II, III, V5‐V6 or STelevation ≥ 2 mm in at least 2 of the leads. d) The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery. e) Patient with acute myocardial infarction within 10 days prior to IP administration. f) Normal liver and renal function. g) Able to understand study information provided to him. h) Able to give voluntary written consent.