Safety Study of Gene Therapy for Ischemic Heart Disease in Korea

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety of VM202RY direct injection into the cardiac muscles of the coronary artery territory where complete revascularization could not be done even through Coronary Artery Bypass Graft.

Clinical Trial Description

All the patients expected to undergo Coronary Artery Bypass Graft 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). VM202RY 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. VM202RY will be administered to Group1 (0.5mg), Group 2 (1mg) and Group 3 (2mg) 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01422772
Study type	Interventional
Source	Helixmith Co., Ltd.
Contact
Status	Completed
Phase	Phase 1
Start date	January 2007
Completion date	August 2014

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