NCT02084407已完成不适用
Induction of Pluripotent Stem Cells From Human Fibroblasts of DM1 Patients
Institut de Myologie, France2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Measure of DM1 alterations in human cardiomyocytes derived from induced pluripotent stem cells
研究概览
简要总结
The objective of the study is the modelisation of human cardiomyocyts from pluripotent stem cells in order to study the cardiac alterations induced by CTG expansions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for DM1 patient with cardiomyopathy:
- •aged 20-50
- •DM1 confirmed by molecular analysis
- •Confirmed cardiomyopathy (infrahissiens conduction disorders)
- •able to sign the consent form
- •affiliated to european social security.
- •Inclusion Criteria for DM1 patient without cardiomyopathy
- •aged 20-50
- •DM1 confirmed by molecular analysis
- •No cardiomyopathy (no infrahissiens conduction disorders or other trouble linked to DM1)
- •able to sign the consent form
- •affiliated to european social security.
- •Inclusion Criteria for controls
- •aged over 18
- •brother, sister, father or mother of the DM1 patient
- •No DM1 confirmed by molecular analysis (CTG repetition under 38)
- •No cardiac disorders.
- •able to sign the consent form
- •affiliated to european social security.
排除标准
- •no pragnant or nursing women
- •patient unable to understand informed consent
- •patient under juridic protection
结局指标
主要结局
Measure of DM1 alterations in human cardiomyocytes derived from induced pluripotent stem cells
时间窗: At baseline
次要结局
- Molecular changes in human DM1 cardiomyocytes expressing pathogenic CUGexp-RNA(At baseline)
研究者
研究点 (2)
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