Overview

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

Status:
Unknown status
Trial end date:
2020-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and clinical efficacy of VM202RY injected via transendocardial route using C-Cathez® catheter (Celyad, S.A., Belgium) in subjects with AMI. - Stage 1: Evaluation of safety and tolerability of VM202RY injection - Stage 2: Evaluation of safety and efficacy of VM202RY injection
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Helixmith Co., Ltd.
ViroMed Co., Ltd.
Treatments:
Mitogens
Criteria
Inclusion Criteria:

1. Age ≥ 19 years to ≤ 75 years

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

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

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 anterior wall
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 and
using acceptable method of birth control during the study; if male, using barrier
method of birth control during study

6. Be capable of understanding and complying with the protocol and signing the informed
consent 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 prosthetic aortic
valve who may not be appropriate to use the C-CATHez® catheter due to the risk of
injury during the interventional procedure through the valve

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

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

14. Patients with a recent history (< 5 years) of, or new screening finding of malignant
neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if
excised and no evidence of recurrence); patients with family history of colon cancer
in any first degree relative are excluded unless they have undergone a colonoscopy in
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 that
preclude standard ophthalmologic examination Diagnosis of proliferative retinopathy or
conditions that preclude standard ophthalmologic examination

17. Subjects currently receiving immunosuppressive medications, chemotherapy, or radiation
therapy

18. Active infectious disease and/or positive Human Immunodeficiency Virus (HIV) or Human
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) at screening

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 x
upper limit of normal (ULN)

- Any other clinically significant lab abnormality which in the opinion of the
investigator should be exclusionary

21. Subjects requiring > 100 mg daily of acetylsalicylic acid (ASA); subjects may be
enrolled 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-specific
COX-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 the
first 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-inflammatory drug)
temporarily (≤ 7 days)

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

24. Pregnancy or lactation

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

26. Exposure to any previous experimental angiogenic therapy and/or myocardial laser
therapy; or therapy with another investigational drug within 180 days of enrollment or
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 the
study conduct or interpretation of the results or who in the opinion of the
investigator are not suitable to participate

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