Safety Study of Gene Therapy for Ischemic Heart Disease in Korea

NCT01422772 | Completed Phase 1 Results

• 1 other identifier: VM202RY-VM01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 even through Coronary Artery Bypass Graft (CABG).

Conditions

Ischemic Heart Disease

Keywords

VM202; Engensis; Coronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (2)

• The Incidence of Adverse Events - Total Adverse Events (AE)

  Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period. Assessments Include: Adverse reactions, vital signs, physical exam, laboratory test results

  24 weeks

• The Severity of Adverse Events - Total Adverse Events by Severity

  Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period. Assessments Include: Adverse reactions, vital signs, physical exam, laboratory test results

  24 weeks

Secondary Outcomes (6)

• Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging

  Day 0, 12 weeks, 24 weeks

• Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography

  Day 0, Day 7, 12 weeks, 24 weeks

• Changes in Size of Viable Myocardium - End-Systolic Thickness

  Day 0, 12 weeks, 24 weeks

• Changes in Size of Viable Myocardium - End-Diastolic Thickness

  Day 0, 12 weeks, 24 weeks

• Changes in Myocardial Ischemic Area - Stress Condition

  Day 0, 12 weeks, 24 weeks

Study Arms (3)

Cohort I

EXPERIMENTAL

0.5 mg/ 1 mL of VM202 was intramyocardially injected into 4 sites

Biological: VM202-0.5 mg

Cohort II

EXPERIMENTAL

1 mg/ 2 mL of VM202 was intramyocardially injected into 8 sites

Biological: VM202-1.0 mg

Cohort III

EXPERIMENTAL

2 mg/ 4 mL of VM202 was intramyocardially injected into 8 sites

Biological: VM202-2.0 mg

Interventions

VM202-0.5 mg BIOLOGICAL

0.5 mg intramyocardial injection

Cohort I

VM202-1.0 mg BIOLOGICAL

1 mg intramyocardial injection

Cohort II

VM202-2.0 mg BIOLOGICAL

2 mg intramyocardial injection

Cohort III

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helixmith Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Kim JS, Hwang HY, Cho KR, Park EA, Lee W, Paeng JC, Lee DS, Kim HK, Sohn DW, Kim KB. Intramyocardial transfer of hepatocyte growth factor as an adjunct to CABG: phase I clinical study. Gene Ther. 2013 Jul;20(7):717-22. doi: 10.1038/gt.2012.87. Epub 2012 Nov 15.

  PMID: 23151518 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Jinsub Lee PhD
• Organization: Helixmith Co., Ltd.

jinsub.lee@helixmith.com

+82-10-8256-0439

Study Officials

• Gibong Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose-escalation

Study Record Dates

• First Submitted: August 21, 2011
• First Posted: August 24, 2011
• Study Start: January 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: August 1, 2014
• Last Updated: October 3, 2025
• Results First Posted: October 3, 2025

Record last verified: 2025-09

Locations

KR (1)