Safety and Efficacy Study of Gene Therapy for Acute Myocardial Infarction in Korea

Inclusion Criteria:

1. Age ≥ 19 years to ≤ 75 years

2. Patients who underwent percutaneous coronary intervention (PCI) for the anteriorwall infarction of left ventricle and had the elapsed time of 30 ± 2 days from thePCI, regardless of success or failure of myocardial revascularization in theanterior wall

3. Patients with > 20% to ≤ 45% of left ventricular ejection fraction viatrans-thoracic echocardiography within 7 days prior to the study drug or placeboinjection

4. Left ventricular wall thickness ≥ 8 mm via trans-thoracic echocardiography (however,the subject shall be included if 50% or greater of the left ventricular anteriorwall is ≥8mm or injection site other than the left ventricular anterior wall is ≥ 8mm.)

5. If female of childbearing potential, negative urine pregnancy test at screening andusing acceptable method of birth control during the study; if male, using barriermethod of birth control during study

6. Be capable of understanding and complying with the protocol and signing the informedconsent document prior to being subjected to any study related procedures.

Exclusion Criteria:

1. Severe systolic heart failure, NYHA Class III or IV

2. New York Heart Association (NYHA) functional class IV

3. History of recurrent ventricular tachycardia or cariogenic shock following PCI

4. Stroke or transient ischemic attack (TIA) within 180 days

5. Uncontrolled hypertension defined as systolic blood pressure ≥ 180 mmHg or diastolic ≥ 110 mmHg at screening and/or on the day of study drug or placebo injection

6. Sustained ventricular tachyarrhythmia or recurrent ventricular tachycardia

7. Implantation of automatic implantable cardioverter defibrillator (AICD)

8. On extracorporeal membrane oxygenator (ECMO)

9. History of ventricular fibrillation after PCI

10. Permanent pacemaker implantation (temporary pacemaker may be enrolled)

11. Subjects with aortic stenosis of moderate or greater degree, or with prostheticaortic valve who may not be appropriate to use the C-CATHez® catheter due to therisk of injury during the interventional procedure through the valve

12. Atherosclerotic or other disease of the aorto-iliac system that would impede thesafe passage of the C-CATHez®

13. Subjects with any serious comorbidities that the investigators deemed to beinappropriate to be enrolled

14. Patients with a recent history (< 5 years) of, or new screening finding of malignantneoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (ifexcised and no evidence of recurrence); patients with family history of colon cancerin any first degree relative are excluded unless they have undergone a colonoscopyin the last 12 months with negative findings

15. Elevated prostate-specific antigen (PSA) despite not having prostate cancer history

16. Ophthalmologic conditions pertinent to proliferative retinopathy or conditions thatpreclude standard ophthalmologic examination Diagnosis of proliferative retinopathyor conditions that preclude standard ophthalmologic examination

17. Subjects currently receiving immunosuppressive medications, chemotherapy, orradiation therapy

18. Active infectious disease and/or positive Human Immunodeficiency Virus (HIV) orHuman T-Cell lymphotropic viruses (HTLV) at screening

19. Active Hepatitis B or C infection as determined by Hepatitis B surface antibody (HBsAb), Hepatitis B core antibody (Immunoglobulin G and Immunoglobulin M; HBcAb),Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) atscreening

20. Specific laboratory values at screening including

• Hemoglobin ≤ 9.0 g/dL, white blood cell (WBC) < 3,000 cells/μl, platelet count < 75,000/mm3

• Creatinine > 2.0 mg/dL

• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 xupper limit of normal (ULN)

• Any other clinically significant lab abnormality which in the opinion of theinvestigator should be exclusionary

21. Subjects requiring > 100 mg daily of acetylsalicylic acid (ASA); subjects may beenrolled if willing/able to switch to ≤ 100 mg daily of ASA or to another medication

22. Subjects regularly taking cyclooxygenase (COX)-2 inhibiting drug(s) or non-specificCOX-1/COX-2 inhibiting drugs, or high dose steroids (except inhaled steroids);subjects may be enrolled if willing/able to undergo medication wash-out prior to thefirst dosing and to refrain from taking these drugs for the duration of the study,and also if the subject is temporarily taking NSAID (non-steroidal anti-inflammatorydrug) temporarily (≤ 7 days)

23. Patients that have undergone enhanced external pulsation (EECP) treatment within thelast 6 months

24. Pregnancy or lactation

25. Severe comorbidity associated with a reduction of life expectancy of less than 1year

26. Exposure to any previous experimental angiogenic therapy and/or myocardial lasertherapy; or therapy with another investigational drug within 180 days of enrollmentor participation in any concurrent study that may confound the results of this study

27. Major psychiatric disorder in the past 6 months

28. Known drug or alcohol dependence or any other factors which will interfere with thestudy conduct or interpretation of the results or who in the opinion of theinvestigator are not suitable to participate

29. Deemed to be in unsuitable condition by the study investigator