MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction)

Safety and Preliminary Efficacy Study of Intravenous Administration of MiSaver® (Myocardial Infarction Saver) After Acute Myocardial Infarction, a Phase I/IIa Clinical Trial.

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)

Inclusion Criteria:

• Patients aged 20~80
• Acute Myocardial Infarction 1 to 10 days
• Cardiac enzyme CK-MB or Troponin > 2X of high-end normal value
• ST-elevation on EKG (STEMI)
• Presence of regional wall motion abnormality
• Left ventricular ejection fraction (LVEF) of ≤40%
• Hemodynamically stable past 24 hour
• Participants with adequate pulmonary function
• Peripheral artery oxygen saturation ≥97%
• Karnofsky performance status scores of ≥60.

Exclusion Criteria:

• Age <20 or >80
• Pregnant or breast feeding
• Positive adventitious infections (such as HIV, hepatitis )
• Revascularization via coronary artery bypass surgery is required
• Coronary revascularization procedures is anticipated during the 6-month study period
• Severe aortic or mitral valve narrowing
• Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)
• Short of breath unable to receive PCI examination or treatment
• Malignant tumor
• Hematopoietic dysplasia
• Severe organ disease
• With less than 1 year of life expectancy
• Chronic kidney disease with CCr<20ml/min
• Kidney disease on renal dialysis