Transplantation of Mesenchymal Stem Cells for Prevention of Acute Myocardial Infarction Induced Heart Failure: a Phase III Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 3
- 主要终点
- Incidence of Heart Failure
研究概览
简要总结
Results from recent clinical trials on bone marrow mononuclear cell (BM-MNC) transplantation show that this intervention can help reduce the incidence of heart failure (HF) after acute myocardial infarction (AMI). However, no study has evaluated the effect of the transplantation of mesenchymal stem cells (MSCs) on a clinical endpoint such as HF.
This single-blinded, randomized, multicenter trial aims to establish whether the intracoronary infusion of umbilical cord-derived Wharton's jelly MSCs (WJ-MSCs) helps prevent HF development after AMI. The study will enroll 240 patients 3 to 7 days following an AMI treated with primary percutaneous coronary intervention (PPCI). Only patients aged below 65 years with impaired LV function (LVEF < 40%) will be included. Patients will be randomized to receive either a single intracoronary infusion of WJ-MSCs or standard care. The primary outcome of this study is the assessment of HF development during long-term follow-up (three years). Since the efficacy of MSCs is higher than BM-MNCs after AMI in the improvement of LVEF, it would be probable that these cells may have a better clinical effect as well. However, no study has evaluated the impact of the transplantation of MSCs on a clinical endpoint such as HF. This study will help determine whether or not the infusion of intracoronary WJ-MSCs in AMI patients with impaired LVEF would prevent HF development and future adverse events.
详细描述
A randomized, multicenter, single-blinded phase III trial will be conducted to assess whether the intracoronary infusion of umbilical cord WJ-MSCs demonstrates a superior effect in reducing HF incidence following AMIs compared to standard treatment.
The sample size was determined with a 5% error, 80% power, a one-year HF incidence rate of 1.3-4%, and division between two groups in a 2:1 ratio (control:intervention), and a three-year follow-up period.
A total of 360 patients with a history of an anterior ST-elevation MI (STEMI) successfully reperfused within standard golden time within 3-7 days after AMI will be enrolled.
Randomization will be done via permuted block randomization through a web-based service. A block size of 4 will be considered. Two groups of equal proportion will be formed, where only one will receive an intracoronary infusion of WJ-MSCs besides the conventional therapy provided to both groups. Those who assess the study outcomes will remain unaware of the allocation (single-blind).
This study will use cGMP-certified clinical-grade human WJ-MSCs. In the intervention group, all 120 patients will receive a single intracoronary infusion of 10^7 WJ-MSCs alongside the conventional treatment that will be provided to the same number of patients in the control group. Patients in the intervention group will be taken to the cardiac catheterization lab, where the infusion of 10^7 WJ-MSCs will be done through the intracoronary route.
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
- Single (Outcomes Assessor)
盲法说明
Single-blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Either gender
- •First myocardial infarction in the preceding 3 to 7 days
- •Post-acute myocardial infarction left ventricular ejection fraction < 40%
- •Negative pregnancy test (for women of reproductive age)
- •Written informed consent
排除标准
- •A history of any prior cardiac conditions (valvular, ischemic, or congenital disorders)
- •Regional wall motion abnormalities outside the region of the infarction
- •LV dysfunction due to other etiologies like non-ischemic cardiomyopathy, anthracycline use, or ethanol abuse (> 6 oz./day regularly)
- •Poor echocardiography window
- •Active infection, malignancy, or autoimmune disease
研究组 & 干预措施
WJ-MSCs intracoronary infusion + standard care
In the experimental group, 3-7 days after an acute anterior myocardial infarction treated successfully with primary percutaneous coronary intervention, 120 patients will receive a single intracoronary infusion of 10^7 umbilical cord-derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs) alongside conventional treatment.
干预措施: Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs) (Biological)
WJ-MSCs intracoronary infusion + standard care
In the experimental group, 3-7 days after an acute anterior myocardial infarction treated successfully with primary percutaneous coronary intervention, 120 patients will receive a single intracoronary infusion of 10^7 umbilical cord-derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs) alongside conventional treatment.
干预措施: Conventional Treatment (Other)
standard care (Control Group)
In the control group, after an acute anterior myocardial infarction treated successfully with primary percutaneous coronary intervention, 240 patients will receive only conventional treatment.
干预措施: Conventional Treatment (Other)
结局指标
主要结局
Incidence of Heart Failure
时间窗: Checked at three years
The incidence of heart failure during the follow-up period.
次要结局
- Change in Left Ventricular Function from base line(At baseline and after six months)
- Composite outcome of cardiovascular death and heart failure incidence(Checked at three years)
- Cardiovascular Death(Checked at three years)
研究者
Armin Attar
Director of cardiovascular regeneration and genetics program, and cardiovascular diseases' registries, Principal Investigator, Clinical Professor
Shiraz University of Medical Sciences