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

NCT03404024 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-09-25

No results posted yet for this study

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

Conditions

  • Ischemic Heart Disease
  • Acute Myocardial Infarction

Interventions

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)

Sponsors & Collaborators

  • Helixmith Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wook Bum Pyun, MD, PhD · Ewha Womans University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2019-08-20
Completion
2019-08-20

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03404024 on ClinicalTrials.gov