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Intracoronary or Intravenous Infusion Human Wharton' Jelly-derived Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (WJ-ICMP Tria)

2019年12月3日 更新者:Navy General Hospital, Beijing

Randomised, Double-blind, Placebo-controlled, Intracoronary or Intravenous Infusion Human Wharton' Jelly-derived Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy

The purpose of this study is to investigate the safety and efficacy of intracoronary or intravenous infusion human umbilical Wharton's jelly-derived Mesenchymal Stem Cell (WJMSC) in patients with ischemic cardiomyopathy secondary to myocardial infarction.

研究概览

详细说明

Ischemic heart failure (IHF) secondary to myocardial infarction is a common, lethal, disabling, and expensive condition. Despite advances over the last 30 years, the prognosis of patients with IHF remains poor. At present, there has been increasing interest in attempting to repair the failing heart with the use of stem cells, since this approach has the potential to regenerate dead myocardium and thus alleviate the underlying cause of IHF.

A very primitive population of mesenchymal stem cells (MSCs) has been isolated from a continuum from the sub-amnion to perivascular region of umbilical cord, referred to as Wharton's jelly-derived MSCs (WJMSCs). WJMSCs retain a combination of most of their embryonic stem cell (ESC) and MSC markers in primary culture and early passages, thus retaining their multipotent stem cell characteristics. Preclinical studies have demonstrated that WJMSCs can be induced to differentiate into cardiomyocytes and endothelial cells and to integrate into the vasculature and ischemic cardiac tissue, as well as to improve heart function significantly. Therefore, the investigators performed a double-blind, placebo-controlled trial, randomly assigning 160 patients with ischemic heart failure secondary to myocardial infarction to receive an intracoronary or intravenous infusion of WJMSCs or placebo, to investigate the therapeutic safety and efficacy of WJMSCs in patients with ischemic cardiomyopathy.

研究类型

介入性

注册 (预期的)

160

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

17年 至 90年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age no limited
  2. Patient must provide written informed consent.
  3. Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by any of the following 3 criteria:

    • Previous MI is documented by a clinical history that includes an elevation of cardiac enzymes and/or electrocardiogram (ECG) changes consistent with MI.
    • Patients treated with thrombolytic therapy or percutaneous coronary revascularization.
    • Screening CMRI shows an area of akinesis, dyskinesis, or severe hypokinesis associated with evidence of myocardial scarring based on delayed hyperenhancement after gadolinium infusion.
  4. Patient has been treated with appropriate maximal medic al therapy for ICMP. For β -blockade, the patient must have be en on a stable dose of a clinically appropriate β-blocker for 3 months. For angiotensin-converting enzyme inhibition, the patient must have been on a stable dose of a clinically appropriate agent for 1 m
  5. left ventricular ejection fraction (LVEF)<45% by echocardiogram, CMRI, or left ventriculogram within the prior 6 m
  6. Patients who are a candidate for cardiac catheterization assignment intracoronary infusion group; but patients in no-candidate for cardiac catheterization assignment intravenous infusion group.

Exclusion Criteria:

  1. Have a baseline glomerular filtration rate > 50 mL/min per 1.73 m2
  2. Evidence of a life-threatening arrhythmia (ventricular tachycardia or complete heart block) on screening ECG..
  3. Have a hematologic abnormality as evidenced by hematocrit <25% , white blood cell <2500/u L or platelet values<100000/u L without another explanation.
  4. Have liver dysfunction , as evidenced by enzymes (aspartate aminotransferase and alanine aminotransferase) >3× the upper limits of normal.
  5. Have a coagulopathy (international normalized ratio > 1.3) not because of a reversible cause (ie, coumadin).
  6. Have a contraindication to performance of CMRI (CMRIs will be performed in patients with pacemaker who are not pacemaker dependent).
  7. Be an organ transplant recipient.
  8. Have a clinical history of malignancy within 5 y except curatively treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
  9. Have a noncardiac condition that limits lifespan to <1y.
  10. Have a history of drug or alcohol abuse within the past 24 m.
  11. Be serum positive for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C.
  12. Be a female who is pregnant, nursing, or of childbearing potential who is not practicing effective contraceptive methods.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:Intracoronary infusion WJMSCs
Intracoronary infusion WJMSCs or placebo in patients with ischemic heart failure
WJMSCs Vs. placebo
安慰剂比较:Intravenous infusion WJMSCs
Intravenous infusion WJMSCs or placebo in patients with ischemic heart failure.
WJMSCs Vs. placebo

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The primary end point was safety in incidence of adverse events (AEs) within 12 months
大体时间:12 months
the incidence of adverse events (AEs) within 12 months, including death, nonfatal MI, stroke, hospitalization for worsening heart function, severe arrhythmias, repeated coronary intervention, stent thrombosis, coronary artery microvascular obstruction, immune system disorders, or ectopic tissue formation, was monitored and quantified. Laboratory assays, including biochemical assays, hematologic, tumor and immune indexes and Holter monitoring, were performed at the different follow-up times at 1 months-1 year. The trial will be monitored by a Data and Safety Monitoring Board (DSMB) and the trial will be discontinued in case of safety concerns.
12 months

次要结果测量

结果测量
措施说明
大体时间
The secondary end point was efficacy in absolute change of the global LV ejection fraction (LVEF) from baseline to 12 months by MRI
大体时间:12 months
The secondary end point was efficacy, which was assessed in terms of the absolute change in the global LV ejection fraction (LVEF) from baseline to 12 months post-treatment, as measured by cardiac magnetic resonance imaging (CMRI). Furthermore, CMRI assessments measured scar mass and viable myocardial mass in the left ventricle, scar size, cardiac volumes, global function, regional function, and 6-min walk tests in all patients from baseline to 12 months post-treatment.
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Ning K Zhang, MS、Navy General Hospital, Beijing

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2020年1月1日

初级完成 (预期的)

2021年1月1日

研究完成 (预期的)

2021年7月1日

研究注册日期

首次提交

2015年2月3日

首先提交符合 QC 标准的

2015年2月20日

首次发布 (估计)

2015年2月23日

研究记录更新

最后更新发布 (实际的)

2019年12月5日

上次提交的符合 QC 标准的更新

2019年12月3日

最后验证

2019年12月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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