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Safety Study of Gene Therapy for Ischemic Heart Disease in Korea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01422772
Recruitment Status : Completed
First Posted : August 24, 2011
Last Update Posted : October 18, 2019
Information provided by (Responsible Party):
Helixmith Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Biological: VM202RY Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cohort I
0.5mg/1mL of VM202RY was intramuscularly injected into 4 sites
Biological: VM202RY
0.5mg intramuscular injection

Experimental: Cohort II
1mg/2mL of VM202RY was intramuscularly injected into 8 sites
Biological: VM202RY
1mg intramuscular injection

Experimental: Cohort III
2mg/4mL of VM202RY was intramuscularly injected into 8 sites
Biological: VM202RY
2mg intramuscular injection

Primary Outcome Measures :
  1. The incidence of adverse events [ Time Frame: 24weeks ]

Secondary Outcome Measures :
  1. Changes in cardiac function, size of viable myocardium and myocardial ischemic area [ Time Frame: Day0, 12weeks, 24weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01422772

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Helixmith Co., Ltd.
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Principal Investigator: Gibong Kim, MD, PhD Seoul National University Hospital
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Responsible Party: Helixmith Co., Ltd. Identifier: NCT01422772    
Other Study ID Numbers: VM202RY-VM01
First Posted: August 24, 2011    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases