NCT03876821已完成不适用
Collect of Cord Blood From Subjects at Risk for Sickle Cell Disease, for the Purpose of Laboratory Research
Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年10月23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
- 44
- 试验地点
- 1
- 主要终点
- Number of samples with HbS/HbS genotype
研究概览
简要总结
The study consists in collecting umbilical cord blood cells from newborns at risk of sickle cell disease, to perform laboratory experiments aiming to characterize the cells with HbS/HbS mutation, to develop methods to prepare, to gene-modify and to preserve these cells.
详细描述
Pregnant individuals carrying at least one HbS allele will be included in the study to collect the umbilical cord blood of the child at birth. Collected cells will be used anonymously for genetic and bioexperimental laboratory research, aiming to develop autologous gene therapy for sickle cell disease.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women, giving birth at CHSF and consenting to the collect and study of placental blood after delivery
- •Age 18 to 45 years
- •Biological testing of the participant includes hemoglobin electrophoresis and shows at least one HbS allele
排除标准
- •Lack of written consent
- •Minors (not 18 years old) or under guardianship
- •Diseases : HIV, Hepatitis B, Hepatitis C or HTLV (Human T Leukemia Virus).
结局指标
主要结局
Number of samples with HbS/HbS genotype
时间窗: 3 years
Measured by DNA sequencing
次要结局
- Number of samples with bio-experimental data(4 years)
研究者
研究点 (1)
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