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Safety Study of Gene Therapy for Ischemic Heart Disease in Korea

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ViroMed Co., Ltd. dba VM BioPharma
ClinicalTrials.gov Identifier:
NCT01422772
First received: August 21, 2011
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Ischemic Heart Disease
Biological: VM202RY
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ViroMed Co., Ltd. dba VM BioPharma:

Primary Outcome Measures:
  • The incidence of adverse events [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in cardiac function, size of viable myocardium and myocardial ischemic area [ Time Frame: Day0, 12weeks, 24weeks ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: January 2007
Estimated Study Completion Date: August 2014
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422772

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
ViroMed Co., Ltd. dba VM BioPharma
Investigators
Principal Investigator: Gibong Kim, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: ViroMed Co., Ltd. dba VM BioPharma
ClinicalTrials.gov Identifier: NCT01422772     History of Changes
Other Study ID Numbers: VM202RY-VM01
Study First Received: August 21, 2011
Last Updated: June 20, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Heart Diseases
Ischemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014