Targeted-cell Therapy Using Epithelial Stem Cells and Patients' Cardiomyocytes Loaded in Amnion Bilayer to Regenerate Myocardial Infarction Post COVID-19 Complication
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Change of the ischemic burden (%)
研究概览
简要总结
Myocardial infarction (MI), as one of the many complications of COVID-19, is one of the contributing patients of patients' death. This study attempts on developing an intervention of MI by regenerating damaged cardiomyocytes due to insufficiency of oxygen in cardiac muscles, triggered by an occlusion of coronary artery (MI). Heart patch developed from amnion bilayer seeded with amnion epithelial stem cells and patient's autologous cardiomyocytes is used as a therapy. Patients who undergo bypass (CABG) surgery are given heart patch, and then patients condition are observed by ECG, Echo, blood test, and radiology (technetium-99m)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40 - 60 years old
- •Ischemic burden >10% and ischemic gradients red-violet
- •Ischemic area is not feasible to be grafted (bypass) due to other conditions such as diffusion and deep intramuscular vascularization
- •Ejection fraction >30-35%
- •Euro score <8
排除标准
- •Scanning of Technetium-99 showed black colored ischemic area
- •Patients undergoing other procedures other than bypass such as valve repair
- •Chronic kidney failure
- •Patients have went through several bypass surgeries prior
- •Patients are still COVID-19 positive
- •Immunocompromised patients
结局指标
主要结局
Change of the ischemic burden (%)
时间窗: Comparison from the imaging within 3 months before intervention, and after 6 months post treatment.
Diagnosed by MRI
Change in the regional heart wall motion abnormality
时间窗: Observation of the heart wall motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention
measured using Echocardiographic
次要结局
- Change of the electrocardiographic wave(Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention)
- Change of the ejection fraction(Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention)
研究者
Normalina Sandora
Normalina Sandora, MD, MSc, PhD
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto