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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.
 
ClinicalTrials.gov Identifier: NCT01422772
Recruitment Status : Completed
First Posted : August 24, 2011
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Helixmith Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 21, 2011
First Posted Date  ICMJE August 24, 2011
Last Update Posted Date October 18, 2019
Study Start Date  ICMJE January 2007
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2011)
The incidence of adverse events [ Time Frame: 24weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2011)
Changes in cardiac function, size of viable myocardium and myocardial ischemic area [ Time Frame: Day0, 12weeks, 24weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Gene Therapy for Ischemic Heart Disease in Korea
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Heart Disease
Intervention  ICMJE
  • Biological: VM202RY
    0.5mg intramuscular injection
  • Biological: VM202RY
    1mg intramuscular injection
  • Biological: VM202RY
    2mg intramuscular injection
Study Arms  ICMJE
  • Experimental: Cohort I
    0.5mg/1mL of VM202RY was intramuscularly injected into 4 sites
    Intervention: Biological: VM202RY
  • Experimental: Cohort II
    1mg/2mL of VM202RY was intramuscularly injected into 8 sites
    Intervention: Biological: VM202RY
  • Experimental: Cohort III
    2mg/4mL of VM202RY was intramuscularly injected into 8 sites
    Intervention: Biological: VM202RY
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2011)
9
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01422772
Other Study ID Numbers  ICMJE VM202RY-VM01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helixmith Co., Ltd.
Study Sponsor  ICMJE Helixmith Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gibong Kim, MD, PhD Seoul National University Hospital
PRS Account Helixmith Co., Ltd.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP