Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to characterize cord blood stem cells of neonates with neonatal asphyxia and to compare them with those from healthy newborn
研究概览
简要总结
Neonatal anoxic-ischaemic enkephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss.
For the moment, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions.
Cord blood stem cells are a promising treatment for the near future. However, before conducting a clinical trial to evaluate the safety and feasibility of autologous cell therapy in neonatal asphyxia, in vitro characterization of the cord blood stem cell in situation of neonatal asphyxia, compared to normal situation, is needed.
The primary objective of this study is to characterize cord blood stem cells of neonates with neonatal asphyxia and to compare them with those from healthy newborn. The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration. Secondary objectives are to assess such characteristics in conditions of cryo-preservation, compared to fresh cell preparation
详细描述
Methods :
Descriptive, bi-centre study on 10 cord blood samples from newborn infants with neonatal asphyxia (5) according to pre-defined criteria, compared healthy neonates (5). The total duration of the study will be 2 years. Parents will be informed and a signed parental consent will be asked in the hours following birth before the in vitro study.
Biological analysis will include elementary analyses for cell quality control, endothelial progenitor exploration, and investigation of mesenchymal stem cells function and of their neuronal differentiation potential (on fresh and frozen samples).
Statistical analysis
comparison between the 2 groups (neonatal asphyxia versus control) would use non parametric test (Mann-Whitney)
This study will allow to evaluate the therapeutic potential of cord blood stem cells autologous transplantation in neonatal asphyxia. It will contribute to the determination of the feasibility of a clinical trail of autologous, cord blood stem cells therapy in such disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 20 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •delivery at 37 week or more of pregnancy
- •normal pregnancy and delivery
排除标准
- •parental refusal
结局指标
主要结局
The primary objective of this study is to characterize cord blood stem cells of neonates with neonatal asphyxia and to compare them with those from healthy newborn
时间窗: two years
The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration.
次要结局
未报告次要终点