跳至主要内容
临床试验/NCT01759212
NCT01759212终止2 期

Safety and Efficacy of Intramyocardial Implantation of Allogeneic Mesenchymal Stem Cells in Patients With End-stage Heart Failure Undergoing Left Ventricular Assist Device Implantation

AHEPA University Hospital1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
终止
入组人数
1
试验地点
1
主要终点
Improvement in myocardial perfusion/viability

研究概览

简要总结

The aim of the study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with end-stage ischemic cardiomyopathy undergoing left ventricular assist device implantation.

详细描述

End-stage ischemic cardiomyopathy (ICM) with non-graftable coronary arteries is a common and debilitating problem. The ultimate therapeutic goal in such cases is cardiac transplantation which is restricted by donor availability. Alternatively, left ventricular assist devices (LVAD) are increasingly used as bridge to transplantation or more recently as destination therapy in non-transplant candidates. Widely used second- and third-generation continuous-flow LVAD offer symptomatic relief and prolong life. However, LV unloading rarely improves native heart function in ischemic hearts. We aim to increase myocardial viability and improve native cardiac function in patients with end-stage ICM by injecting allogeneic bone marrow stem cells at the time of LVAD implantation.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18 to 75 years
  • •End-stage heart failure due to ischemic cardiomyopathy that requires mechanical support according to current indications
  • •Ability to provide informed consent

排除标准

  • •Not willing to provide informed consent

研究组 & 干预措施

Stem cells implantation

Experimental

Patients with end-stage heart failure due to ischemic cardiomyopathy will undergo combined cellular and mechanical support with implantation of off-the-shelf allogeneic mesenchymal stem cells and left ventricular assist device.

干预措施: Allogeneic stem cells implantation (Biological)

结局指标

主要结局

Improvement in myocardial perfusion/viability

时间窗: 24 months

Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis

Improvement in myocardial perfusion/viability

时间窗: 12 months

Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis

次要结局

  • Change in left ventricular function(one year)
  • Morbidity(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyriakos Anastasiadis

Professor Kyriakos Anastasiadis

AHEPA University Hospital

研究点 (1)

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