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Ischemic Heart DiseasePhase 2NCT03404024

Safety and Efficacy Study of Gene Therapy for Acute Myocardial Infarction in Korea

A Phase 2 study testing Stage 1-Low dose VM202RY, Stage 1-Middle dose VM202RY and Stage 1-High dose VM202RY in people with Ischemic Heart Disease and Acute Myocardial Infarction, run by Helixmith Co., Ltd. at 4 sites in South Korea.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and clinical efficacy of VM202RY injected via transendocardial route using C-Cathez® catheter (Celyad, S.A., Belgium) in subjects with AMI. Read more about this study

Who is it for?
Ages 19 to 75 years
What is being tested?
Stage 1-Low dose VM202RY, Stage 1-Middle dose VM202RY and Stage 1-High dose VM202RY
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
4 sitesSouth Korea
Study dates
25 Jan 2018to 20 Aug 2019
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Age ≥ 19 years to ≤ 75 years
  • 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
  • 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
  • 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.)
  • 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
  • Be capable of understanding and complying with the protocol and signing the informed consent document prior to being subjected to any study related procedures.

Who cannot join

  • Severe systolic heart failure, NYHA Class III or IV
  • New York Heart Association (NYHA) functional class IV
  • History of recurrent ventricular tachycardia or cariogenic shock following PCI
  • Stroke or transient ischemic attack (TIA) within 180 days
  • 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
  • Sustained ventricular tachyarrhythmia or recurrent ventricular tachycardia
Show all 33Show fewer
  • Implantation of automatic implantable cardioverter defibrillator (AICD)
  • On extracorporeal membrane oxygenator (ECMO)
  • History of ventricular fibrillation after PCI
  • Permanent pacemaker implantation (temporary pacemaker may be enrolled)
  • 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
  • Atherosclerotic or other disease of the aorto-iliac system that would impede the safe passage of the C-CATHez®
  • Subjects with any serious comorbidities that the investigators deemed to be inappropriate to be enrolled
  • 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
  • Elevated prostate-specific antigen (PSA) despite not having prostate cancer history
  • Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination Diagnosis of proliferative retinopathy or conditions that preclude standard ophthalmologic examination
  • Subjects currently receiving immunosuppressive medications, chemotherapy, or radiation therapy
  • Active infectious disease and/or positive Human Immunodeficiency Virus (HIV) or Human T-Cell lymphotropic viruses (HTLV) at screening
  • 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
  • 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
  • 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
  • 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)
  • Patients that have undergone enhanced external pulsation (EECP) treatment within the last 6 months
  • Pregnancy or lactation
  • Severe comorbidity associated with a reduction of life expectancy of less than 1 year
  • 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
  • Major psychiatric disorder in the past 6 months
  • 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
  • Deemed to be in unsuitable condition by the study investigator

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • GangNeung Asan Hospital

    Gangneung

  • Chonnam National University Hospital

    Gwangju

  • Ewha Womans University Medical Center

    Seoul

  • KyungHee University Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: A Phase II, Multicenter, Adaptive-design Study to Assess the Safety and Efficacy of VM202RY Injected Via Percutaneous Transendocardial Route in Subjects With Acute Myocardial Infarction

The purpose of this study is to evaluate the safety and clinical efficacy of VM202RY injected via transendocardial route using C-Cathez® catheter (Celyad, S.A., Belgium) in subjects with AMI.

  • Stage 1: Evaluation of safety and tolerability of VM202RY injection
  • Stage 2: Evaluation of safety and efficacy of VM202RY injection
Read the detailed description

Ischemic heart disease, a condition in which narrowed or blocked coronary arteries lead to ischemia in myocardium, is a group of disease that include: angina and myocardial infarction.

Acute myocardial infarction (AMI) predicts rapid progression of necrosis. AMI is a serious health condition that it's mortality rate is about 30% and also more likely to have a higher incidence of cardiac dysrhythmia or ventricular aneurysm.

Therapeutic angiogenesis is promising approach for the treatment of cardiovascular disease. 66 to 75% of coronary artery disease patients have insufficient coronary collaterals and 30% of myocardial infarction patients display inadequate myocardial perfusion although there are procedures like percutaneous coronary intervention or coronary artery bypass graft surgery.

In phase I study for ischemic heart disease, VM202RY appeared to have improved regional myocardial perfusion and wall thickness of the diastolic and systolic phases in the injected region. These results suggest that VM202RY improves the myocardial perfusion and inhibits cardiac remodeling in ischemic heart disease patients.

Being tested
Stage 1-Low dose VM202RY, Stage 1-Middle dose VM202RY, Stage 1-High dose VM202RY, Stage 2-Placebo, Stage 2-Low dose VM202RY
Keywords
gene therapy
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stage 1-Low dose VM202RYBiological

    Also called DNA Plasmid, Hepatocyte growth factor (HGF)-X7

    Day 0: 1mg of VM202RY (4 sites of 0.25mg/0.5mL VM202RY)

  • Stage 1-Middle dose VM202RYBiological

    Also called DNA Plasmid, HGF-X7

    Day 0: 2mg of VM202RY (8 sites of 0.25mg/0.5mL VM202RY)

  • Stage 1-High dose VM202RYBiological

    Also called DNA Plasmid, HGF-X7

    Day 0: 3mg of VM202RY (12 sites of 0.25mg/0.5mL VM202RY)

  • Stage 2-PlaceboDrug

    Also called VM202RY vehicle, Sodium chloride, sucrose

    Day 0: 6mL of VM202RY vehicle (12 sites of 0.5mL 1.1% sucrose/0.9% NaCl)

  • Stage 2-Low dose VM202RYBiological

    Also called DNA plasmid, HGF-X7

    Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, low dose candidate-0.5mg VM202RY, 1mg VM202RY, 1.5mg VM202RY)

  • Stage 2-High dose VM202RYBiological

    Also called DNA Plasmid, HGF-X7

    Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, high dose candidate-1mg VM202RY, 2mg VM202RY, 3mg VM202RY)

  • C-Cathez® CatheterDevice

    Day 0 (Stage 1-Low dose VM202RY): 1mg of VM202RY (4 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 1-Middle dose VM202RY): 2mg of VM202RY (8 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 1-High dose VM202RY): 3mg of VM202RY (12 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 2-Placebo): 6mL of VM202RY vehicle (12 sites of 0.5mL 1.1% sucrose/0.9% NaCl) Day 0 (Stage 2-Low dose VM202RY): 6mL of VM202RY and VM202RY vehicle (total 12 site injections, low dose candidate-0.5mg VM202RY, 1mg VM202RY, 1.5mg VM202RY) Day 0 (Stage 2-High dose VM202RY): 6mL of VM202RY and VM202RY vehicle (total 12 site injections, high dose candidate-1mg VM202RY, 2mg VM202RY, 3mg VM202RY)

Study groups in NCT03404024
Study groupRoleWhat they receive
Stage 1-Low dose VM202RYExperimentalPatients in this group will receive total 1mg of VM202RY. (4 sites of 0.25mg/0.5 mL VM202RY)
Receives: Biological: Stage 1-Low dose VM202RY; Device: C-Cathez® Catheter
Stage 1-Middle dose VM202RYExperimentalPatients in this group will receive total 2mg of VM202RY. (8 sites of 0.25mg/0.5 mL VM202RY)
Receives: Biological: Stage 1-Middle dose VM202RY; Device: C-Cathez® Catheter
Stage 1-High dose VM202RYExperimentalPatients in this group will receive total 3mg of VM202RY. (12 sites of 0.25mg/0.5 mL VM202RY)
Receives: Biological: Stage 1-High dose VM202RY; Device: C-Cathez® Catheter
Stage 2-PlaceboPlacebo comparatorPatients in this group will receive 6mL of VM202RY vehicle. (12 sites of 0.5mL 0.9% NaCl, 1.1% sucrose)
Receives: Drug: Stage 2-Placebo; Device: C-Cathez® Catheter
Stage 2-Low dose VM202RYExperimentalPatients in this group will receive total 6mL of VM202RY and VM202RY vehicle. (The dose of VM202RY can be one of the three candidate-0.5mg VM202RY/1mg VM202RY/1.5mg VM202RY based on the tolerated dose result from Stage 1.)
Receives: Biological: Stage 2-Low dose VM202RY; Device: C-Cathez® Catheter
Stage 2-High dose VM202RYExperimentalPatients in this group will receive total 6mL of VM202RY and VM202RY vehicle. (The dose of VM202RY can be one of the three candidate-1mg VM202RY/2mg VM202RY/3mg VM202RY based on the tolerated dose result from Stage 1.)
Receives: Biological: Stage 2-High dose VM202RY; Device: C-Cathez® Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stage 1: MTD (maximum tolerated dose)

    • MTD is defined as the dose level below the dose at which ≥ 33% of participants experienced DLT (dose limiting toxicity). The DLT assessment will be conducted on day 14. Toxicities more severe than grade 3 on the WHO toxicity scale will be designated as DLT. The dose where severe adverse events occur according to the Spilker classification will also be designated as DLT. The assessment will be conducted from the lowest dose to higher doses incrementally. MTD will be measured in milligrams (mg).

    Measured: 6 months

  2. Stage 2: LVEF (left ventricular ejection fraction) measured by cardiac MRI

    • The change in LVEF measured by cardiac MRI in VM202RY and placebo will be compared at 6 months after the treatment of VM202RY or Placebo by transendocardial injections using C-CATHez® catheter. LVEF will be measured in percentage (%).

    Measured: 6 months

Secondary outcomes (16)

  1. Change in left ventricular diameter (cardiac MRI)

    The change in diameter of left ventricle will be measured in millimeters (mm), at months 3 and 6 using cardiac MRI.

    Measured: 3 and 6 months

  2. Change in left ventricular diameter (TTE)

    The change in diameter of left ventricle will be measured in millimeters (mm), at months 3 and 6 using TTE (transthoracic echocardiogram).

    Measured: 3 and 6 months

  3. Change in left ventricular volume (cardiac MRI)

    The change in volume of left ventricle will be measured in milliliters (mL), at months 3 and 6 using cardiac MRI.

    Measured: 3 and 6 months

  4. Change in left ventricular volume (TTE)

    The change in volume of left ventricle will be measured in milliliters (mL), at months 3 and 6 using TTE.

    Measured: 3 and 6 months

  5. Change in cardiac output (cardiac MRI)

    The change in cardiac output will be measured in liters per minute (L/min), at months 3 and 6 using cardiac MRI.

    Measured: 3 and 6 months

  6. Change in cardiac output (TTE)

    The change in cardiac output will be measured in liters per minute (L/min), at months 3 and 6 using TTE.

    Measured: 3 and 6 months

  7. Change in LVEF (cardiac MRI)

    The change in left ventricular ejection fraction will be measured in percentage (%), at months 3 and 6 using cardiac MRI.

    Measured: 3 and 6 months

  8. Change in LVEF (TTE)

    The change in left ventricular ejection fraction will be measured in percentage (%), at months 3 and 6 using TTE.

    Measured: 3 and 6 months

  9. Change in wall motion score index (cardiac MRI)

    The wall motion score index will be measured at months 3 and 6 using cardiac MRI.

    Measured: 3 and 6 months

  10. Change in wall motion score index (TTE)

    The wall motion score index will be measured at months 3 and 6 using TTE.

    Measured: 3 and 6 months

  11. Change in myocardial wall thickness (cardiac MRI)

    The change in myocardial wall thickness of the investigational-product or placebo injected area will be measured in millimeters (mm) at months 3 and 6 using cardiac MRI.

    Measured: 3 and 6 months

  12. Change in extent of late enhancement of gadolinium (cardiac MRI)

    The change in extent of late enhancement of gadolinium will be measured at months 3 and 6 using cardiac MRI.

    Measured: 3 and 6 months

  13. Change in rest perfusion (cardiac MRI)

    The change in rest perfusion will be measured in percentage (%) at months 3 and 6 using cardiac MRI.

    Measured: 3 and 6 months

  14. Change in rest perfusion (myocardial SPECT)

    The change in rest perfusion will be measured in percentage (%) at months 3 and 6 using myocardial SPECT.

    Measured: 3 and 6 months

  15. Change in stress perfusion (cardiac MRI)

    The change in stress perfusion will be measured in percentage (%) at months 3 and 6 using cardiac MRI.

    Measured: 3 and 6 months

  16. Change in stress perfusion (myocardial SPECT)

    The change in stress perfusion will be measured in percentage (%) at months 3 and 6 using myocardial SPECT.

    Measured: 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2018
  2. Study start25 Jan 2018 (estimated)
  3. Primary completion20 Aug 2019 (estimated)
  4. Study completion20 Aug 2019 (estimated)

Why it stopped: Company decided not to move forward with this study.

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03404024
Sponsor's protocol ID
VMCAD-002
Status last verified
Aug 2025
First submitted
16 Aug 2017
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stage 1-Low dose VM202RY, Stage 1-Middle dose VM202RY and Stage 1-High dose VM202RY in people with Ischemic Heart Disease and Acute Myocardial Infarction, run by Helixmith Co., Ltd. at 4 sites 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 6 inclusion and 33 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: withdrawn, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Stage 1: MTD (maximum tolerated dose) (time frame: 6 months). 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 NCT03404024.

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 25 Sep 2025.

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