Safety and Efficacy Investigation of Patients With Ischemic Cardiomyopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The examination of heart function
研究概览
简要总结
The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .
详细描述
Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses umbilical cord blood derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart. The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 30 to 80 years
- •ischemic cardiomyopathy
- •Left ventricular infarction area seriously low movement to no movement
- •The low whole left ventricular systolic function (LVEF 45% or less)
- •Have line or quasi coronary interventional treatment
- •Willing to accept patients with follow-up evaluation
- •Have signed informed consent form approved by the ethics committee
排除标准
- •Non elevation between S-wave and T-wave in patients with acute myocardial infarction
- •No function damage in patients with acute myocardial infarction
- •Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery
- •Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.)
- •Acute infectious diseases
- •Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc
- •Severe renal disease, creatinine clearance < 36 ml/min, serum creatinine > 265 umol/L
- •Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) > 4 times the upper limit of normal
- •Unstable cerebral lesions
- •malignant tumor
- •Cognitive dysfunction and dementia patients, patients with severe mental illness
- •Patients with severe physical disabilities can't regular follow-up
- •Other serious uncontrolled system disease
- •To prepare or have the pregnancy women patients
- •Have a percutaneous coronary intervention contraindications: high-risk patients, such as the digestive tract, and intracranial hemorrhage or contrast allergy
- •Cannot use the test dose atorvastatin
- •Is not completed in accordance with the requirements for test the timing of the magnetic resonance imaging (MRI), PET, SPECT, follow-up testing (e.g., patients with implanted pacemakers or artificial joint)
- •Patients unable or unwilling to sign a consent form
研究组 & 干预措施
mesenchymal stem cells
Stem cells implantation Patients with severe coronary artery disease with ischemic cardiomyopathy managed with intramyocardial administration of allogeneic mesenchymal stem cells.
干预措施: mesenchymal stem cells (Biological)
结局指标
主要结局
The examination of heart function
时间窗: Post cell transplantation: 1, 3, 6 months
Left ventricular ejection fraction： Change in left ventricular ejection fraction assessed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.
次要结局
- major adverse cardiac and cerebrovascular events(Post cell transplantation: one year)
- all-cause mortality(Post cell transplantation: one year)
- all-cause morbidity(Post cell transplantation: one year)
研究者
Quanhai Li
Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Hebei Medical University