Safety and Efficacy Evaluation of Umbilical Cord Mesenchymal Stem Cells Transcatheter Transplantation to Treat Left Ventricular Dysfunction After Acute Myocardial Infarction
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety measured as the number of Major Adverse Cardiac Events (MACE)
研究概览
简要总结
A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation
详细描述
In this study, 40 patients with cardiac insufficiency after acute myocardial infarction were selected and randomly divided into umbilical cord MSCs transplantation treatment group and non-intervention control group to preliminarily observe the safety and effectiveness of MSCs cell transplantation treatment.
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute extensive anterior myocardial infarction were successfully treated with emergency interventional therapy within 12 hours after onset. LVEF was less than 0.35 by echocardiography 30 days after operation, scar area was more than 25% by MRI, and cardiac function was NYHA III-IV grade.
- •Fully inform the purpose, method and possible side effects of the test, agree to the test, and sign an informed consent form;
- •Good compliance, willing to take drugs and follow up according to the requirements of the plan;
- •Life expectancy exceeds one year.
排除标准
- •Those who cannot tolerate cell therapy;
- •Patients with severe hepatic and renal insufficiency (ALT>1.5 times the upper limit of normal value, Cr >1.5 times the upper limit of normal value);
- •Patients with malignant tumors or extremely weak patients;
- •Patients with severe infection;
- •Patients who are expected to have the second coronary intervention or bypass grafting within 3 months;
- •Patients with other serious systemic diseases and organ dysfunction;
- •Patients with cardiogenic shock;
- •Patients with hemorrhagic diseases;
- •Researchers believe that anyone who is not suitable for inclusion
研究组 & 干预措施
Control Group
Routine treatment
干预措施: Control Group (Biological)
UC-MSC
UC-MSC transplantation
干预措施: UC-MSC (Biological)
结局指标
主要结局
Safety measured as the number of Major Adverse Cardiac Events (MACE)
时间窗: 12 months
Possible adverse events, including adverse events that may occur during angiography and infusion of transplanted cells such as chest pain, arrhythmia, slow blood flow, myocardial injury, fever, allergic reaction, postoperative infection, etc.
次要结局
- Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up(12 months)