Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
This is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury. The cord blood used is fresh (not frozen and then thawed).
详细描述
The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth and have cord blood collected at birth can receive their own cord blood cells during the 3 days of age. Babies will be followed for neurodevelopmental outcome at 1, 4 - 6, 9 - 12 months and 18-24 months. MRI brain will be obtained at 1-2 weeks and 4-6 months old.
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
- •Autologous umbilical cord blood available
- •>36 weeks gestation
- •Brain injury that satisfies criteria for therapeutic hypothermia
- •Parental informed consent
排除标准
- •Inability to enroll by 3 postnatal days of age.
- •Presence of known chromosomal anomaly.
- •Presence of major congenital anomalies.
- •Severe intrauterine growth restriction
- •Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
- •Parents refuse consent.
- •Attending neonatologist refuses consent.
- •Failure to collect the infant's cord blood and/or laboratory unable to process cord blood
结局指标
主要结局
Safety
时间窗: 1-3 days of age
Adverse event rates occurring in the recipients
次要结局
- Brain imaging(1 week-6 months)
- Neurodevelopment(1 month-2 years old)