Phase 2
Completed N=9
Safety Study of Gene Therapy for Ischemic Heart Disease in Korea
Source: ClinicalTrials.gov NCT01422772 ↗Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Oct 2025
Primary outcomePrimary: The Incidence of Adverse Events - Total Adverse Events (AE) — 58; 18; 36; 0 Total AEs
Summary
The purpose of this study is to evaluate the safety of VM202 (Engensis) direct injection into the cardiac muscles of the coronary artery territory where complete revascularization could not be done even through Coronary Artery Bypass Graft (CABG).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Adverse Events - Total Adverse Events (AE) |
58; 18; 36; 0; 0; 0 | — |
| PRIMARY The Severity of Adverse Events - Total Adverse Events by Severity |
31; 6; 12; 27; 12; 24 | — |
| SECONDARY Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging |
1.77; 1.63; 2.67; 0.45; 6.80; 0.13 | — |
| SECONDARY Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography |
-1.00; 0.0; -1.0; 3.0; -2.0; -1.33 | — |
| SECONDARY Changes in Size of Viable Myocardium - End-Systolic Thickness |
0.58; 0.08; 0.93; 0.99; 0.36; 1.15 | — |
| SECONDARY Changes in Size of Viable Myocardium - End-Diastolic Thickness |
0.47; 0.71; 0.44; 1.85; 0.43; 0.17 | — |
| SECONDARY Changes in Myocardial Ischemic Area - Stress Condition |
7.83; 8.33; 1.67; 7.50; 5.00; 5.33 | — |
| SECONDARY Changes in Myocardial Ischemic Area - Resting Condition |
7.33; 0.83; 4.67; -3.50; 1.33; 5.17 | — |
Eligibility Criteria
Inclusion Criteria
- Patients aged ≥ 19 and ≤ 75 years
- Patients in whom decrease of myocardial perfusion in coronary artery territories (rest perfusion - stress perfusion: ≥ 7%) was observed by myocardial SPECT
- Patients judged to have possibly incomplete revascularization based on the observation of the coronary artery's internal diameter of ≤ 1 mm, diffuse atherosclerosis or severe calcification on coronary angiography, or patients judged to have some myocardial perfusion territories that could not be performed Coronary Artery Bypass Graft
- Patients who or whose legal representative can write the informed consent before the initiation of the clinical study and comply with the requirements
Exclusion Criteria
- Patients with progressive or present heart failure
- Patients with uncontrolled ventricular arrhythmia on electrocardiogram, or who have been treated for ventricular arrhythmia
- Patients with current or history of malignant tumor
- Patients with severe infectious disease
- Patients with uncontrolled hematologic disorders
- Patients requiring surgery for the accompanying valve diseases or left ventricular volume reduction surgery
- Patients with current or history of proliferative retinopathy
- Patients with remaining life of less than 1 year and severe accompanying diseases enough to die during the clinical follow-up period
- Patients with history of drug or alcohol abuse within the recent 3 months
- Women who are pregnant or breast feeding or postmenopausal women of childbearing age. However, women who underwent surgical sterilization including hysterectomy or bilateral tubal ligation can participate in this clinical trial. Even though they consent to the contraception, they cannot be enrolled.
- Patients in inappropriate condition judged by investigators
- Patients with cerebrovascular diseases (cerebral infarction, cerebral bleeding or transient ischemic attack that are currently occurring or occurred within 6 months)
- Patients with idiopathic hypertension who are not controlled with drugs
- Patients with severe hepatic disorders
- Patients with severe renal disorders
- Patients who underwent Coronary Artery Bypass Graft
- Patients who underwent angioplasty within 1 year before their enrollment in the study
Data sourced from ClinicalTrials.gov (NCT01422772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.