Trial · NCT01422772
Safety Study of Gene Therapy for Ischemic Heart Disease in Korea
NCT01422772, Phase 1, Phase 2, Completed, Helixmith Co., Ltd.; results first posted 2025-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of Gene Therapy for Ischemic Heart Disease in Korea. Trials, record NCT01422772. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01422772
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Gene Therapy for Ischemic Heart Disease in Korea
- NCT number
- NCT01422772
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Helixmith Co., Ltd.
- Conditions
- Ischemic Heart Disease
- Interventions
- VM202-0.5 mg, VM202-1.0 mg, VM202-2.0 mg
- First posted
- 2011-08-24
- Last updated
- 2025-10-03
- Results first posted
- 2025-10-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Incidence of Adverse Events - Total Adverse Events (AE) | 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 |
| Primary | The Severity of Adverse Events - Total Adverse Events by Severity | 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 |
| Secondary | Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging | Day 0, 12 weeks, 24 weeks | 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. |
| Secondary | Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Day 0, Day 7, 12 weeks, 24 weeks | 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. |
| Secondary | Changes in Size of Viable Myocardium - End-Systolic Thickness | Day 0, 12 weeks, 24 weeks | 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. |
| Secondary | Changes in Size of Viable Myocardium - End-Diastolic Thickness | Day 0, 12 weeks, 24 weeks | 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. |
| Secondary | Changes in Myocardial Ischemic Area - Stress Condition | Day 0, 12 weeks, 24 weeks | 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 |
| Secondary | Changes in Myocardial Ischemic Area - Resting Condition | Day 0, 12 weeks, 24 weeks | 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 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Incidence of Adverse Events - Total Adverse Events (AE) | 24 weeks | Total Number of Adverse Events (ITT Safety) | Total AEs | NUMBER |
| PRIMARY | The Severity of Adverse Events - Total Adverse Events by Severity | 24 weeks | Total Adverse Events by Severity (ITT Safety) | Total AEs | NUMBER |
| SECONDARY | Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging | Day 0, 12 weeks, 24 weeks | Intent to Treat - Left Ventricular Ejection Percentage Fraction - Measured by Magnetic Resonance Imaging (MRI) | percentage of change from screening | MEAN |
| SECONDARY | Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography | Day 0, Day 7, 12 weeks, 24 weeks | Intent to Treat - Left Ventricular Ejection Percentage Fraction - Measured by Trans Thoracic Echocardiography | percentage of change from screening | MEAN |
| SECONDARY | Changes in Size of Viable Myocardium - End-Systolic Thickness | Day 0, 12 weeks, 24 weeks | Intent to Treat - myocardium thickness by Magnetic Resonance Imaging - End-Systolic Thickness | mm | MEAN |
| SECONDARY | Changes in Size of Viable Myocardium - End-Diastolic Thickness | Day 0, 12 weeks, 24 weeks | Intent to Treat - myocardium thickness by Magnetic Resonance Imaging - End-Diastolic Thickness | mm | MEAN |
| SECONDARY | Changes in Myocardial Ischemic Area - Stress Condition | Day 0, 12 weeks, 24 weeks | Intent to Treat - Changes in Myocardial Ischemic Area evaluated by SPECT based on Percentage of perfusion volume - Stress Condition | percentage of Perfusion Volume | MEAN |
| SECONDARY | Changes in Myocardial Ischemic Area - Resting Condition | Day 0, 12 weeks, 24 weeks | Intent to Treat - Changes in Myocardial Ischemic Area evaluated by SPECT based on Percentage of perfusion volume - Resting Condition | percentage of Perfusion Volume | MEAN |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Incidence of Adverse Events - Total Adverse Events (AE) | Group 1 - 0.5 mg/1 mL | Treatment Emergent AEs | 58 | Total AEs | |
| The Incidence of Adverse Events - Total Adverse Events (AE) | Group 2 - 1.0 mg/2 mL | Treatment Emergent AEs | 18 | Total AEs | |
| The Incidence of Adverse Events - Total Adverse Events (AE) | Group 3 - 2 mg/4 mL | Treatment Emergent AEs | 36 | Total AEs | |
| The Incidence of Adverse Events - Total Adverse Events (AE) | Group 1 - 0.5 mg/1 mL | AEs related to Investigational Product | 0 | Total AEs | |
| The Incidence of Adverse Events - Total Adverse Events (AE) | Group 2 - 1.0 mg/2 mL | AEs related to Investigational Product | 0 | Total AEs | |
| The Incidence of Adverse Events - Total Adverse Events (AE) | Group 3 - 2 mg/4 mL | AEs related to Investigational Product | 0 | Total AEs | |
| The Incidence of Adverse Events - Total Adverse Events (AE) | Group 1 - 0.5 mg/1 mL | Serious Adverse Events | 2 | Total AEs | |
| The Incidence of Adverse Events - Total Adverse Events (AE) | Group 2 - 1.0 mg/2 mL | Serious Adverse Events | 0 | Total AEs | |
| The Incidence of Adverse Events - Total Adverse Events (AE) | Group 3 - 2 mg/4 mL | Serious Adverse Events | 0 | Total AEs | |
| The Severity of Adverse Events - Total Adverse Events by Severity | Group 1 - 0.5 mg/1 mL | Grade 1/Mild-Severity of AEs | 31 | Total AEs |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 - 0.5 mg/1 mL | 3 | |
| Overall Study | STARTED | Group 2 - 1.0 mg/2 mL | 3 | |
| Overall Study | STARTED | Group 3 - 2 mg/4 mL | 3 | |
| Overall Study | COMPLETED | Group 1 - 0.5 mg/1 mL | 3 | |
| Overall Study | COMPLETED | Group 2 - 1.0 mg/2 mL | 3 | |
| Overall Study | COMPLETED | Group 3 - 2 mg/4 mL | 3 | |
| Overall Study | NOT COMPLETED | Group 1 - 0.5 mg/1 mL | 0 | |
| Overall Study | NOT COMPLETED | Group 2 - 1.0 mg/2 mL | 0 | |
| Overall Study | NOT COMPLETED | Group 3 - 2 mg/4 mL | 0 |
Source ClinicalTrials.gov
Adverse events171
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Supraventricular extrasystoles | Cardiac disorders | Group 1 - VM202 - 0.5 mg/ 1mL | 3 | 3 | 4 |
| other | Supraventricular extrasystoles | Cardiac disorders | Group 2 - VM202 - 1.0 mg/2 mL | 1 | 3 | 1 |
| other | Supraventricular extrasystoles | Cardiac disorders | Group 3 - VM202 - 2 mg/4 mL | 2 | 3 | 5 |
| other | Atrial fibrillation | Cardiac disorders | Group 1 - VM202 - 0.5 mg/ 1mL | 0 | 3 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Group 2 - VM202 - 1.0 mg/2 mL | 0 | 3 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Group 3 - VM202 - 2 mg/4 mL | 3 | 3 | 5 |
| other | Sinus tachycardia | Cardiac disorders | Group 1 - VM202 - 0.5 mg/ 1mL | 1 | 3 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Group 2 - VM202 - 1.0 mg/2 mL | 1 | 3 | 2 |
| other | Sinus tachycardia | Cardiac disorders | Group 3 - VM202 - 2 mg/4 mL | 1 | 3 | 1 |
| other | Supraventricular tachycardia | Cardiac disorders | Group 1 - VM202 - 0.5 mg/ 1mL | 1 | 3 | 1 |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 - VM202 - 0.5 mg/ 1mL | 0 | 3 |
| Total, all-cause mortality | Group 2 - VM202 - 1.0 mg/2 mL | 0 | 3 |
| Total, all-cause mortality | Group 3 - VM202 - 2 mg/4 mL | 0 | 3 |
| Total, other adverse events | Group 1 - VM202 - 0.5 mg/ 1mL | 3 | 3 |
| Total, other adverse events | Group 2 - VM202 - 1.0 mg/2 mL | 3 | 3 |
| Total, other adverse events | Group 3 - VM202 - 2 mg/4 mL | 3 | 3 |
| Total, serious adverse events | Group 1 - VM202 - 0.5 mg/ 1mL | 1 | 3 |
| Total, serious adverse events | Group 2 - VM202 - 1.0 mg/2 mL | 0 | 3 |
| Total, serious adverse events | Group 3 - VM202 - 2 mg/4 mL | 0 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23151518 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01422772
GET https://conductscience.org/api/trials/v1/NCT01422772/results?page=2