Heart attack gene therapy trial pulled before it began
NCT ID NCT03404024
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study aimed to test a gene therapy called VM202RY in people who recently had a heart attack. The treatment was injected directly into the heart muscle to help it heal and improve pumping strength. However, the trial was withdrawn before enrolling any participants, so no data on safety or effectiveness were collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VM202RY (a DNA plasmid that produces hepatocyte growth factor)
- What this could lead to
- If it worked, this could point toward a treatment to help heart muscle recover after a heart attack, potentially improving pumping function.
- What could go wrong
- The study was withdrawn before any patients were enrolled, so no results are available. Even if tested, early-stage gene therapies often fail to show benefit or may cause side effects like inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
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Jan 2018
An estimate. Start dates often move.
- Expected to finish
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Aug 2019
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 19 years to ≤ 75 years 2. Patients who underwent percutaneous coronary intervention (PCI) for the anterior wall infarction of left ventricle and had the elapsed time of 30 ± 2 days from the PCI, regardless of success or failure of myocardial revascularization in the anterior wall 3. Patients with \> 20% to ≤ 45% of left ventricular ejection fraction via trans-thoracic echocardiography within 7 days prior to the study drug or placebo injection 4. Left ventricular wall thickness ≥ 8 mm via trans-thoracic echocardiography (however, the subject shall be included if 50% or greater of the left ventricular anterior wall is ≥8mm or injection site other than the left ventricular anterior wall is ≥ 8mm.) 5. If female of childbearing potential, negative urine pregnancy test at screening and using acceptable method of birth control during the study; if male, using barrier method of birth control during study 6. Be capable of understanding and complying with the protocol and signing the informed consent document prior to being subjected to any study related procedures. Exclusion Criteria: 1. Severe systolic heart failure, NYHA Class III or IV 2. New York Heart Association (NYHA) functional class IV 3. History of recurrent ventricular tachycardia or cariogenic shock following PCI 4. Stroke or transient ischemic attack (TIA) within 180 days 5. Uncontrolled hypertension defined as systolic blood pressure ≥ 180 mmHg or diastolic ≥ 110 mmHg at screening and/or on the day of study drug or placebo injection 6. Sustained ventricular tachyarrhythmia or recurrent ventricular tachycardia 7. Implantation of automatic implantable cardioverter defibrillator (AICD) 8. On extracorporeal membrane oxygenator (ECMO) 9. History of ventricular fibrillation after PCI 10. Permanent pacemaker implantation (temporary pacemaker may be enrolled) 11. Subjects with aortic stenosis of moderate or greater degree, or with prosthetic aortic valve who may not be appropriate to use the C-CATHez® catheter due to the risk of injury during the interventional procedure through the valve 12. Atherosclerotic or other disease of the aorto-iliac system that would impede the safe passage of the C-CATHez® 13. Subjects with any serious comorbidities that the investigators deemed to be inappropriate to be enrolled 14. Patients with a recent history (\< 5 years) of, or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence); patients with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings 15. Elevated prostate-specific antigen (PSA) despite not having prostate cancer history 16. Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination Diagnosis of proliferative retinopathy or conditions that preclude standard ophthalmologic examination 17. Subjects currently receiving immunosuppressive medications, chemotherapy, or radiation therapy 18. Active infectious disease and/or positive Human Immunodeficiency Virus (HIV) or Human T-Cell lymphotropic viruses (HTLV) at screening 19. Active Hepatitis B or C infection as determined by Hepatitis B surface antibody (HBsAb), Hepatitis B core antibody (Immunoglobulin G and Immunoglobulin M; HBcAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) at screening 20. Specific laboratory values at screening including * Hemoglobin ≤ 9.0 g/dL, white blood cell (WBC) \< 3,000 cells/μl, platelet count \< 75,000/mm3 * Creatinine \> 2.0 mg/dL * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN) * Any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary 21. Subjects requiring \> 100 mg daily of acetylsalicylic acid (ASA); subjects may be enrolled if willing/able to switch to ≤ 100 mg daily of ASA or to another medication 22. Subjects regularly taking cyclooxygenase (COX)-2 inhibiting drug(s) or non-specific COX-1/COX-2 inhibiting drugs, or high dose steroids (except inhaled steroids); subjects may be enrolled if willing/able to undergo medication wash-out prior to the first dosing and to refrain from taking these drugs for the duration of the study, and also if the subject is temporarily taking NSAID (non-steroidal anti-inflammatory drug) temporarily (≤ 7 days) 23. Patients that have undergone enhanced external pulsation (EECP) treatment within the last 6 months 24. Pregnancy or lactation 25. Severe comorbidity associated with a reduction of life expectancy of less than 1 year 26. Exposure to any previous experimental angiogenic therapy and/or myocardial laser therapy; or therapy with another investigational drug within 180 days of enrollment or participation in any concurrent study that may confound the results of this study 27. Major psychiatric disorder in the past 6 months 28. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate 29. Deemed to be in unsuitable condition by the study investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chonnam National University Hospital
Gwangju, South Korea
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Ewha Womans University Medical Center
Seoul, South Korea
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GangNeung Asan Hospital
Gangneung, South Korea
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KyungHee University Medical Center
Seoul, South Korea
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