NCT02635464已完成1 期
The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (hUC-MSCs) With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
The study is designed to assess the safety and efficacy of allogeneic human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) with injectable collagen scaffold transplanted into patients with chronic ischemic cardiomyopathy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 35-65 years old.
- •Chronic coronary artery disease with coronary Stenosis detectable by percutaneous coronary intervention (PCI). Ineligibility for percutaneous revascularization, as assessed by coronary arteriography. Ineligibility for percutaneous revascularization procedures was determined by 2 expert committees: a surgical committee comprising 2 cardiovascular surgeons and a noninvasive cardiologist, and an interventional committee comprising 2 interventional cardiologists and 1 noninvasive cardiologist.
- •MRI confirmed that chronic coronary artery disease and ischemic regions.
- •Left ventricular ejection fraction (LVEF)≤40%.
- •NYHA Class II-IV.
- •No organ dysfunction for lung, liver and kidney.
- •Patients are able and willing to observe therapeutic effect and adverse events.
- •Signed informed consent.
- •Negative serum pregnancy test.
- •No coagulation dysfunction.
- •Glycated hemoglobin ≤6.5.
排除标准
- •Lactating or pregnant woman.
- •Ineligibility for CABG.
- •Unexplainable baseline laboratory abnormalities.
- •Sensitivity to any of the study medications.
- •Acute myocardial infarction within 1 months of enrollment in the study.
- •Patients suffering cardiovascular disease, such as aortic disease, malignant arrhythmias, congenital heart disease, intracardiac mass, moderate or severe valvular stenosis or regurgitation.
- •History of life threatening allergic or immune-mediated reaction.
- •Systemic infection or severe local infection.
- •Shock or MODS or patients cannot cooperate with doctors.
- •Severe heart, lung, liver or renal dysfunction.
- •Taking medicine that might have effect on outcomes assess.
- •Suffering HIV, Hepatitis B or Hepatitis C.
- •Participation in any clinical trial in recent three months.
- •History of mental illness or suicide risk.
- •High expectation or unrealistic demands.
- •Recently suffered a lot of radiation exposure.
- •Previous or current history of neoplasia or other comorbidity that could impact the patient's short-term survival.
- •Patients with serious complications of coronary artery disease (e.g., perforation of interventricular septum and ventricular aneurysm and mitral regurgitation due to papillary muscle dysfunction).
- •Abnormal coagulation function.
- •Patients with hemodynamic instability which may lead to serious complications.
- •Any condition that, in the judgment of the investigator, would place the patient at under risk.
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: up to 24 months after surgery
Adverse events (AEs), serious adverse events (SAEs) and changes in vital signs, electrocardiogram (ECG) and laboratory values were measured.
次要结局
- Left ventricle ejection fraction (LVEF)(1, 3, 6, 12 and 24 months)
- Infarct size(1, 3, 6, 12 and 24 months)
- Myocardial blood flow(1, 3, 6, 12 and 24 months)
- New York Heart Association (NYHA) Functional Classification(1, 3, 6, 12 and 24 months)
- Canadian Cardiovascular Society (CCS) Angina Grading Scale(1, 3, 6, 12 and 24 months)
研究者
Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Chinese Academy of Sciences
研究点 (1)
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