Safety Study of Gene Therapy for Ischemic Heart Disease in Korea

Ischemic Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422772
• Other study ID #: VM202RY-VM01
• Status: Completed
• Phase: Phase 1
• Start date: January 2007
• Est. completion date: August 2014

Study information

• Verified date: October 2019
• Source: Helixmith Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2014
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients aged = 19 and = 75 years

2. Patients in whom decrease of myocardial perfusion in coronary artery territories (rest perfusion - stress perfusion: = 7%) was observed by myocardial SPECT

3. 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

4. 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:

1. Patients with progressive or present heart failure

2. Patients with uncontrolled ventricular arrhythmia on electrocardiogram, or who have been treated for ventricular arrhythmia

3. Patients with current or history of malignant tumor

4. Patients with severe infectious disease

5. Patients with uncontrolled hematologic disorders

6. Patients requiring surgery for the accompanying valve diseases or left ventricular volume reduction surgery

7. Patients with current or history of proliferative retinopathy

8. Patients with remaining life of less than 1 year and severe accompanying diseases enough to die during the clinical follow-up period

9. Patients with history of drug or alcohol abuse within the recent 3 months

10. 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.

11. Patients in inappropriate condition judged by investigators

12. Patients with cerebrovascular diseases (cerebral infarction, cerebral bleeding or transient ischemic attack that are currently occurring or occurred within 6 months)

13. Patients with idiopathic hypertension who are not controlled with drugs

14. Patients with severe hepatic disorders

15. Patients with severe renal disorders

16. Patients who underwent Coronary Artery Bypass Graft

17. Patients who underwent angioplasty within 1 year before their enrollment in the study

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Biological:
• VM202RY
0.5mg intramuscular injection
• VM202RY
1mg intramuscular injection
• VM202RY
2mg intramuscular injection

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Helixmith Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events		24weeks
Secondary	Changes in cardiac function, size of viable myocardium and myocardial ischemic area		Day0, 12weeks, 24weeks