Status:
COMPLETED
Safety Study of Gene Therapy for Ischemic Heart Disease in Korea
Lead Sponsor:
Helixmith Co., Ltd.
Conditions:
Ischemic Heart Disease
Eligibility:
All Genders
19-75 years
Phase:
PHASE1
PHASE2
Brief 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 ev...
Detailed Description
All the patients expected to undergo Coronary Artery Bypass Graft (CABG) will screen for the participation in the clinical study. Subjects who signed the informed consent will receive all the screenin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01422772
Start Date
January 1 2007
End Date
August 1 2014
Last Update
October 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, South Korea