Co-transplantation of Mesenchymal Stem Cell Derived Exosomes and Autologous Mitochondria for Patients Candidate for CABG Surgery With EF< 25% (Clinical Trial Phase ])
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- ejection fraction
研究概览
简要总结
Heart failure (HF) and acute myocardial infarction that often follows are among the main causes of disability and death worldwide. As such, new treatments and biological drugs are needed to protect the heart against the harmful effects of ischemia and also reperfusion injury (IRI), preserve cardiac function, reduce the zone of myocardial infarction (MI), and improve patient outcomes. In this regard, it has been shown that mitochondrial dysfunction has a key role in the pathogenesis of heart ischemia, cardiomyopathy, and reperfusion injury. in this study which includes 4 groups of intervention, we try to minimize the damage by transplantation of mitochondria and administration of MSC-derived exosomes. MSC-derived exosomes limit inflammatory damage while fresh autologous exosomes limit oxidative stress.
详细描述
This research will be performed as a retrospective cohort study at Tehran Heart Center. Patients will be selected from CABG candidates with severely low Ejection fraction determined by speckle echocardiography. Patients with severe co-morbidities or cerebral damage will be excluded from the study. Detailed informed consent will be taken from the patients. Patients who refuse to provide consent will receive standard treatment.
Criteria
Inclusion Criteria:
- Patients who are a candidate for CABG due to CAD±MR
- History of Q-wave MI, less than one month
- Age: 35-80
- LVEF <=25% (by any imaging modality: echocardiography/SPECT/LV angiography and Cardiac MRI)
- Viability study as evidenced by low-dose dobutamine stress echocardiogram and/or thallium redistribution nuclear study (at least four viable segments).
Exclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients who are candidate for CABG due to CAD±MR
- •History of Q-wave MI, less than one month
- •Age: 35-80
- •LVEF <=25% (by any imaging modality: echocardiography/SPECT/LV angiography and Cardiac MRI)
- •Viability study as evidenced by low-dose dobutamine stress echocardiogram and/or or thallium redistribution nuclear study (at least four viable segments).
排除标准
- •Severe co-morbidities (e.g., renal failure, liver failure, etc.)
- •Inability to provide informed consent
- •Cerebral Damage
结局指标
主要结局
ejection fraction
时间窗: 3 months
left ventricle ejection fraction
allergic reactions
时间窗: 3 months
reactions including angioedema, hypotention, acute allergic reaction
次要结局
- ECMO duration(duration after surgery if needed)
- NYHA(1 and 3 months post surgery)
- CMR(1 and 3 months post surgery)
- CK-MB(2 week)
- on pump duration(during the surgery)
- cTnT(2 week)
- SPECT(1 and 3 months post surgery)
研究者
Ahmadi tafti
professor
Tehran University of Medical Sciences