Ischemic Heart DiseasePhase 1/2EngensisNCT01422772
Safety Study of Gene Therapy for Ischemic Heart Disease in Korea
A Phase 1/2 study testing VM202-0.5 mg, VM202-1.0 mg and VM202-2.0 mg in people with Ischemic Heart Disease, run by Helixmith Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety of VM202 (Engensis) direct injection into the cardiac muscles of the coronary artery territory where complete revascularization could not be done even through Coronary Artery Bypass Graft (CABG). Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- VM202-0.5 mg, VM202-1.0 mg and VM202-2.0 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Aug 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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 postmenopausal 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Non-comparative, Dose-escalation, Single-center, Phase 1 Trial to Evaluate the Safety of VM202RY Gene Medicine Injected Into Cardiac Muscle of Incompletely Revascularized Area After CABG in Patients With Ischemic Heart Diseases
The purpose of this study is to evaluate the safety of VM202 (Engensis) direct injection into the cardiac muscles of the coronary artery territory where complete revascularization could not be done even through Coronary Artery Bypass Graft (CABG).
Read the detailed description
All the patients expected to undergo Coronary Artery Bypass Graft (CABG) 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). VM202 (Engensis) 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. VM202 (Engensis) will be administered to Group1 (0.5 mg), Group 2 (1 mg) and Group 3 (2 mg) 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.
Safety: Evaluated for 6 months after the administration of VM202 (Engensis).
- Dose-Limiting Toxicity (DLT)
- Tolerated Dose (TD)
- Adverse events, vital signs, physical examination and laboratory test values
- Major Adverse Cardiac Event (MACE) - cardiac death, myocardial infarction, ventricular arrhythmia requiring treatment, or hospitalization for revascularization of target blood vessels)
- Safety of VM202 intramyocardial injection: persistent hemorrhage, arrhythmia and other complications
Secondary endpoints
- Efficacy
- Changes in cardiac function: Left ventricular ejection fraction and cardiac function in the local region by cardiac MRI (Magnetic Resonance Imaging), myocardial SPECT (99 mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography) and Trans Thoracic echocardiography (TTE)
- Size of viable myocardium: By cardiac MRI (myocardial thickness of intramyocardial gene injection site, gadolinium late contrast enhancement range and the exercise intensity of the local region)
- Changes in myocardial ischemic area: By myocardial SPECT (blood flow changes at intramyocardial gene injection site from resting to stress condition)
- Conditions
- Ischemic Heart Disease
- Being tested
- VM202-0.5 mg, VM202-1.0 mg, VM202-2.0 mg
- Keywords
- VM202, Engensis, Coronary Artery Bypass Graft
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VM202-0.5 mgBiological
0.5 mg intramyocardial injection
VM202-1.0 mgBiological
1 mg intramyocardial injection
VM202-2.0 mgBiological
2 mg intramyocardial injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort I | Experimental | 0.5 mg/ 1 mL of VM202 was intramyocardially injected into 4 sites Receives: Biological: VM202-0.5 mg |
| Cohort II | Experimental | 1 mg/ 2 mL of VM202 was intramyocardially injected into 8 sites Receives: Biological: VM202-1.0 mg |
| Cohort III | Experimental | 2 mg/ 4 mL of VM202 was intramyocardially injected into 8 sites Receives: Biological: VM202-2.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Adverse Events - Total Adverse Events (AE)
Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period.
Assessments Include:
Adverse reactions, vital signs, physical exam, laboratory test results
Measured: 24 weeks
The Severity of Adverse Events - Total Adverse Events by Severity
Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period.
Assessments Include:
Adverse reactions, vital signs, physical exam, laboratory test results
Measured: 24 weeks
Secondary outcomes (6)
Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging
Changes in Percentage of Left Ventricular Ejection Fraction by Cardiac Magnetic Resonance Imaging (MRI). Cardiac MRI will be used to monitor for the development of intramyocardial hemangiomas. Analysis will follow the standard cardiac MRI protocols of the Department of Radiology at Seoul National University Hospital, using an appropriate segment model based on the patient's heart size. Parameters evaluated will include left ventricular volume (mL), wall motion index, myocardial thickness (mm), and LVEF (%). Comparisons will be made between baseline/screening and follow-up measurements for each patient, as well as between treatment groups.
Measured: Day 0, 12 weeks, 24 weeks
Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography
Changes from screening in cardiac function evaluated based on Percentage of Left Ventricular Ejection Fraction by cardiac Trans-thoracic Echocardiography (TTE). From transthoracic echocardiography, left ventricular diameter (mm), ejection fraction (%), and wall thickness (mL) will be measured and compared from Screening/Baseline to follow-up results after surgery. The Wall Motion Score Index will be calculated by dividing the myocardium into 16 segments and assigning a score to each area based on motion: [1 = normal, 2 = hypokinetic, 3 = akinetic, 4 = dyskinetic]. The total score for the entire myocardium and the right coronary artery region will be averaged by the number of segments.
Measured: Day 0, Day 7, 12 weeks, 24 weeks
Changes in Size of Viable Myocardium - End-Systolic Thickness
The size of the viable myocardium was evaluated based on the myocardium thickness at the site of intramyocardial gene injection by Magnetic Resonance Imaging - End-Systolic Thickness. Using cardiac MRI, the myocardial thickness at the gene injection site, the extent of late gadolinium enhancement, and local wall motion strength will be evaluated. Differences between groups before and after VM202RY administration will be tested using the Kruskal-Wallis test.
Measured: Day 0, 12 weeks, 24 weeks
Changes in Size of Viable Myocardium - End-Diastolic Thickness
The size of the viable myocardium was evaluated based on the myocardium thickness at the site of intramyocardial gene injection by Magnetic Resonance Imaging - End-Diastolic Thickness. Using cardiac MRI, the myocardial thickness at the gene injection site, the extent of late gadolinium enhancement, and local wall motion strength will be evaluated. Differences between groups before and after VM202RY administration will be tested using the Kruskal-Wallis test.
Measured: Day 0, 12 weeks, 24 weeks
Changes in Myocardial Ischemic Area - Stress Condition
Changes in Myocardial Ischemic Area evaluated by 99mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography (SPECT) based on Percentage of perfusion volume - Stress Condition
Measured: Day 0, 12 weeks, 24 weeks
Changes in Myocardial Ischemic Area - Resting Condition
Changes in Myocardial Ischemic Area evaluated by 99mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography (SPECT) based on Percentage of perfusion volume - Resting Condition
Measured: Day 0, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startJan 2007
- Primary completionFeb 2010
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Dose-escalation
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helixmith Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gibong Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422772
- Sponsor's protocol ID
- VM202RY-VM01
- Acronym
- Engensis
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2011
- Last updated
- 3 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kim JS, Hwang HY, Cho KR, Park EA, Lee W, Paeng JC, Lee DS, Kim HK, Sohn DW, Kim KB. Intramyocardial transfer of hepatocyte growth factor as an adjunct to CABG: phase I clinical study. Gene Ther. 2013 Jul;20(7):717-22. doi: 10.1038/gt.2012.87. Epub 2012 Nov 15.
PubMed 23151518
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-comparative, Dose-escalation, Single-center, Phase 1 Trial to Evaluate the Safety of VM202RY Gene Medicine Injected Into Cardiac Muscle of Incompletely Revascularized Area After CABG in Patients With Ischemic Heart Diseases
- ClinicalTrials.gov ID
- NCT01422772
- Acronym / sponsor ID
- Engensis / VM202RY-VM01
- Conditions
- Ischemic Heart Disease
- Keywords
- VM202, Engensis, Coronary Artery Bypass Graft
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Helixmith Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Aug 2011 (estimated)
- Results
- Posted 3 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of VM202 (Engensis) direct injection into the cardiac muscles of the coronary artery territory where complete revascularization could not be done even through Coronary Artery Bypass Graft (CABG).
Detailed description
All the patients expected to undergo Coronary Artery Bypass Graft (CABG) 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). VM202 (Engensis) 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. VM202 (Engensis) will be administered to Group1 (0.5 mg), Group 2 (1 mg) and Group 3 (2 mg) 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.
Safety: Evaluated for 6 months after the administration of VM202 (Engensis).
- Dose-Limiting Toxicity (DLT)
- Tolerated Dose (TD)
- Adverse events, vital signs, physical examination and laboratory test values
- Major Adverse Cardiac Event (MACE) - cardiac death, myocardial infarction, ventricular arrhythmia requiring treatment, or hospitalization for revascularization of target blood vessels)
- Safety of VM202 intramyocardial injection: persistent hemorrhage, arrhythmia and other complications
Secondary endpoints
- Efficacy
- Changes in cardiac function: Left ventricular ejection fraction and cardiac function in the local region by cardiac MRI (Magnetic Resonance Imaging), myocardial SPECT (99 mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography) and Trans Thoracic echocardiography (TTE)
- Size of viable myocardium: By cardiac MRI (myocardial thickness of intramyocardial gene injection site, gadolinium late contrast enhancement range and the exercise intensity of the local region)
- Changes in myocardial ischemic area: By myocardial SPECT (blood flow changes at intramyocardial gene injection site from resting to stress condition)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose-escalation
| Arm | Type | Receives |
|---|---|---|
| Cohort I | Experimental | Biological: VM202-0.5 mg0.5 mg/ 1 mL of VM202 was intramyocardially injected into 4 sites |
| Cohort II | Experimental | Biological: VM202-1.0 mg1 mg/ 2 mL of VM202 was intramyocardially injected into 8 sites |
| Cohort III | Experimental | Biological: VM202-2.0 mg2 mg/ 4 mL of VM202 was intramyocardially injected into 8 sites |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VM202-0.5 mg0.5 mg intramyocardial injection | Biological | Cohort I |
| VM202-1.0 mg1 mg intramyocardial injection | Biological | Cohort II |
| VM202-2.0 mg2 mg intramyocardial injection | Biological | Cohort III |
Primary outcome
The Incidence of Adverse Events - Total Adverse Events (AE)
Time frame: 24 weeks
Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period. Assessments Include: Adverse reactions, vital signs, physical exam, laboratory test results
The Severity of Adverse Events - Total Adverse Events by Severity
Time frame: 24 weeks
Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period. Assessments Include: Adverse reactions, vital signs, physical exam, laboratory test results
6 secondary outcomes
Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging
Time frame: Day 0, 12 weeks, 24 weeks
Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography
Time frame: Day 0, Day 7, 12 weeks, 24 weeks
Changes in Size of Viable Myocardium - End-Systolic Thickness
Time frame: Day 0, 12 weeks, 24 weeks
Changes in Size of Viable Myocardium - End-Diastolic Thickness
Time frame: Day 0, 12 weeks, 24 weeks
Changes in Myocardial Ischemic Area - Stress Condition
Time frame: Day 0, 12 weeks, 24 weeks
Changes in Myocardial Ischemic Area - Resting Condition
Time frame: Day 0, 12 weeks, 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23151518Kim JS, Hwang HY, Cho KR, Park EA, Lee W, Paeng JC, Lee DS, Kim HK, Sohn DW, Kim KB. Intramyocardial transfer of hepatocyte growth factor as an adjunct to CABG: phase I clinical study. Gene Ther. 2013 Jul;20(7):717-22. doi: 10.1038/gt.2012.87. Epub 2012 Nov 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gibong Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VM202-0.5 mg, VM202-1.0 mg and VM202-2.0 mg in people with Ischemic Heart Disease, run by Helixmith Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Adverse Events - Total Adverse Events (AE) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01422772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.