Safety Study of Gene Therapy for Ischemic Heart Disease in Korea - Full Text View

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:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease Heart Diseases

U.S. FDA Resources

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

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:

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

Contacts and Locations

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.

VM Biopharma

Investigators

Principal Investigator:

Gibong Kim, MD, PhD

Seoul National University Hospital

More Information

No publications provided

Responsible Party:	ViroMed Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01422772 History of Changes
Other Study ID Numbers:	VM202RY-VM01
Study First Received:	August 21, 2011
Last Updated:	August 22, 2011
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013