Safety Study of Gene Therapy for Ischemic Heart Disease in Korea
NCT01422772 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2025-10-03
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).
Conditions
- Ischemic Heart Disease
Interventions
- BIOLOGICAL
-
VM202-0.5 mg
0.5 mg intramyocardial injection
- BIOLOGICAL
-
VM202-1.0 mg
1 mg intramyocardial injection
- BIOLOGICAL
-
VM202-2.0 mg
2 mg intramyocardial injection
Sponsors & Collaborators
-
Helixmith Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Gibong Kim, MD, PhD · Seoul National University Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-01-31
- Primary Completion
- 2010-02-28
- Completion
- 2014-08-31
Countries
- South Korea
Study Locations
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