Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse clinical or paraclinical event rates due to stem cell preparation
研究概览
简要总结
Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss.
Currently, 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.
The primary objective of this study is to test the safety and feasibility of a curative treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy.
The secondary objectives are to test the efficacy of this curative treatment with cell with neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum timing of cell preparation administration
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
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term ≥ 36 weeks of gestation
- •and (2) :
- •a blood pH < 7 with base deficit > 12 mmol/l (at birth or within 60 minutes of age)
- •or a blood pH between 7,01 and 7,15, with additionnal criteria:
- •a history of acute perinatal event (e.g : abnormal fetal cardiac rate, cord prolapse, uterine rupture, maternal hemorrhage)
- •and a 5 minutes Apgar score ≤ 5, or a continued need for resuscitation, including endotracheal or mask ventilation at 5 min after birth.
- •signs of encephalopathy within 12 hours of age (Sarnat and Sarnat classification, score ≥ 2)
- •± abnormal electroencephalogram or aEEG within 12 hours of age
- •therapeutic hypothermia.
- •no maternal infection with VIH, HTLV 1 or 2, Hepatitis B or C virus.
- •maternal negative serology for syphilis
- •written parental consent
排除标准
- •presence of known chromosomal anomaly.
- •presence of major congenital anomalies. severe intrauterine growth restriction (weight <1800g)
- •infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
研究组 & 干预措施
Neonatal hypoxic-ischaemic encephalopathy
干预措施: autologous cord blood stem cell (Drug)
结局指标
主要结局
Adverse clinical or paraclinical event rates due to stem cell preparation
时间窗: 2years
次要结局
- - Preliminary efficacy as measured by neurodevelopmental function(2years)