NCT01422772

Safety Study of Gene Therapy for Ischemic Heart Disease in Korea

Open-label, Non-comparative, Dose-escalation, Single-center, Phase 1 Trial to Evaluate the Safety of VM202RY Gene Medicine Injected Into Cardiac Muscle of Incompletely Revascularized Area After CABG in Patients With Ischemic Heart Diseases

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Helixmith Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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 screening tests within 21 days before surgery (Day 0). VM202 (Engensis) will be injected into 4 sites or 8 sites on the coronary artery where complete revascularization was not done since vascular anastomosis could not be performed due to the bad vascular condition during surgery. VM202 (Engensis) will be administered to Group1 (0.5 mg), Group 2 (1 mg) and Group 3 (2 mg) at different concentrations. Subjects will be scheduled to get inpatient treatment during the gene therapy period (7 days) and follow-up tests at Week 2, 4, 8, 12 and 24 based on surgery day (Day 0). Adverse events and concomitant drugs will be checked. Safety: Evaluated for 6 months after the administration of VM202 (Engensis). 1. Dose-Limiting Toxicity (DLT) 2. Tolerated Dose (TD) 3. Adverse events, vital signs, physical examination and laboratory test values 4. Major Adverse Cardiac Event (MACE) - cardiac death, myocardial infarction, ventricular arrhythmia requiring treatment, or hospitalization for revascularization of target blood vessels) 5. Safety of VM202 intramyocardial injection: persistent hemorrhage, arrhythmia and other complications Secondary endpoints \- Efficacy 1. Changes in cardiac function: Left ventricular ejection fraction and cardiac function in the local region by cardiac MRI (Magnetic Resonance Imaging), myocardial SPECT (99 mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography) and Trans Thoracic echocardiography (TTE) 2. Size of viable myocardium: By cardiac MRI (myocardial thickness of intramyocardial gene injection site, gadolinium late contrast enhancement range and the exercise intensity of the local region) 3. Changes in myocardial ischemic area: By myocardial SPECT (blood flow changes at intramyocardial gene injection site from resting to stress condition)

Conditions

• Ischemic Heart Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-02-01
• Completion: 2014-08-01
• First posted: 2011-08-24
• Last updated: 2025-10-03
• Results posted: 2025-10-03

Locations

1 site across 1 country: South Korea