Trials / Withdrawn
WithdrawnNCT03404024
Safety and Efficacy Study of Gene Therapy for Acute Myocardial Infarction in Korea
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Helixmith Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Not accepted
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. * Stage 1: Evaluation of safety and tolerability of VM202RY injection * Stage 2: Evaluation of safety and efficacy of VM202RY injection
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Stage 1-Low dose VM202RY | Day 0: 1mg of VM202RY (4 sites of 0.25mg/0.5mL VM202RY) |
| BIOLOGICAL | Stage 1-Middle dose VM202RY | Day 0: 2mg of VM202RY (8 sites of 0.25mg/0.5mL VM202RY) |
| BIOLOGICAL | Stage 1-High dose VM202RY | Day 0: 3mg of VM202RY (12 sites of 0.25mg/0.5mL VM202RY) |
| DRUG | Stage 2-Placebo | Day 0: 6mL of VM202RY vehicle (12 sites of 0.5mL 1.1% sucrose/0.9% NaCl) |
| BIOLOGICAL | Stage 2-Low dose VM202RY | Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, low dose candidate-0.5mg VM202RY, 1mg VM202RY, 1.5mg VM202RY) |
| BIOLOGICAL | Stage 2-High dose VM202RY | Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, high dose candidate-1mg VM202RY, 2mg VM202RY, 3mg VM202RY) |
| DEVICE | C-Cathez® Catheter | 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) |
Timeline
- Start date
- 2018-01-25
- Primary completion
- 2019-08-20
- Completion
- 2019-08-20
- First posted
- 2018-01-19
- Last updated
- 2025-09-25
Locations
4 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03404024. Inclusion in this directory is not an endorsement.