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Safety Study of Gene Therapy for Ischemic Heart Disease in Korea

Primary Purpose

Ischemic Heart Disease

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

VM202RY

About this trial

This is an interventional treatment trial for Ischemic Heart Disease

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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 premenopausal 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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort I

Cohort II

Cohort III

Arm Description

0.5mg/1mL of VM202RY was intramuscularly injected into 4 sites

1mg/2mL of VM202RY was intramuscularly injected into 8 sites

2mg/4mL of VM202RY was intramuscularly injected into 8 sites

Outcomes

Primary Outcome Measures

The incidence of adverse events

Secondary Outcome Measures

Changes in cardiac function, size of viable myocardium and myocardial ischemic area

Full Information

NCT ID

NCT01422772

First Posted

August 21, 2011

Last Updated

October 16, 2019

Sponsor

Helixmith Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01422772

Brief Title

Safety Study of Gene Therapy for Ischemic Heart Disease in Korea

Official Title

Open-label, Dose-escalation, Phase 1 Trial to Evaluate the Safety of VM202RY Gene Medicine Injected Into Myocardial Territory With Incomplete Revascularization During Coronary Artery Bypass Graft in Patients With Ischemic Heart Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Helixmith Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort I

Arm Type

Experimental

Arm Description

0.5mg/1mL of VM202RY was intramuscularly injected into 4 sites

Arm Title

Cohort II

Arm Type

Experimental

Arm Description

1mg/2mL of VM202RY was intramuscularly injected into 8 sites

Arm Title

Cohort III

Arm Type

Experimental

Arm Description

2mg/4mL of VM202RY was intramuscularly injected into 8 sites

Intervention Type

Biological

Intervention Name(s)

VM202RY

Intervention Description

0.5mg intramuscular injection

Intervention Type

Biological

Intervention Name(s)

VM202RY

Intervention Description

1mg intramuscular injection

Intervention Type

Biological

Intervention Name(s)

VM202RY

Intervention Description

2mg intramuscular injection

Primary Outcome Measure Information:

Title

The incidence of adverse events

Time Frame

24weeks

Secondary Outcome Measure Information:

Title

Changes in cardiac function, size of viable myocardium and myocardial ischemic area

Time Frame

Day0, 12weeks, 24weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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 premenopausal 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gibong Kim, MD, PhD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

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Safety Study of Gene Therapy for Ischemic Heart Disease in Korea

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