跳至主要内容
临床试验/NCT01576757
NCT01576757撤回不适用

Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies

University of Louisville1 个研究点 分布在 1 个国家开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures.

研究概览

简要总结

The purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible.

详细描述

Heart failure is a devastating condition affecting nearly 6 million patients in the United States alone. Ischemic cardiomyopathy, or pump failure secondary to previous heart attack, is considered by many to be the leading cause of heart failure. Stem cell therapy, or regeneration of the lost myocardium, is an intervention that has the potential for reversing the detrimental effects of this disease. Recently published evidence has shown preliminary results indicating the safety and feasibility of utilizing cardiac stem cells for the treatment of ischemic cardiomyopathy. The ability to use a commonly practiced method, such as endomyocardial biopsy, to isolate and expand stem cell cultures could, potentially, make this therapy widely available. The results of this study will be important for the design of future clinical trials.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

入选标准

  • Any heart failure patient scheduled for RHC without contraindication for biopsy.
  • Any patient undergoing biopsy for diagnostic purposes may also be included in the study.

排除标准

  • Severe comorbidities (AST, ALT, serum creatinine > 3 times the upper limit of normal).
  • Pregnancy or women of childbearing potential.
  • Anticoagulation which cannot be stopped for 5-7 days.
  • Hepatitis B, C or HIV.
  • Inability to give informed consent.

结局指标

主要结局

Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures.

时间窗: 6 weeks

次要结局

未报告次要终点

研究者

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

Roberto Bolli

Endowed Chair Professor

University of Louisville

研究点 (1)

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