The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 主要终点
- safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants
研究概览
简要总结
To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury
详细描述
The purpose of this study is to evaluate the safety and effect of infusions of autologous (the patient's own)umbilical cord blood stem cells in newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth whose mothers have previously consented to providing cord blood stem cells for the Gunagdong Cord Blood Bank,or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood stem cells if an adequate number of cells that meet Guangdong Cord Blood Bank Quality standards are available in the first 14 postnatal days. Study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. Babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months. MRI's will be obtained per clinical routine and results will be analyzed and described in study reports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mothers must have consented for cord blood collection at delivery
- •cord blood must be available for extraction of stem cells.
- •>28 weeks gestation,<37weeks gestation
- •cord or neonatal pH<7.0 or base deficit>16 milliequivalents per liter (mEq/L) or history of acute perinatal event
- •either a 10 minute Apgar < 5 or continued need for ventilation.
- •All infants must have signs of encephalopathy within 6 hours of age.
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.
- •Parents refuse consent.
- •Attending neonatologist refuses consent.
- •Failure to collect the infant's cord blood and/or laboratory unable to process cord blood.
研究组 & 干预措施
Placebo
preterm infants with severe hypoxic ischemic encephalopathy receive only 0.9% Sodium-chloride
干预措施: 0.9% Sodium-chloride (Drug)
infusion
preterm infants with severe hypoxic ischemic encephalopathy will receive up to 4 infusions of their own volume reduced cord blood stem cells. The number of doses will be determined by the amount of available cord blood stem cells. The dose for each infusion is 5x107 cells/kg
干预措施: autologous umbilical cord blood stem cells (Other)
结局指标
主要结局
safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants
时间窗: during infusion 24 hours after infusion
Adverse event rates occurring will be compared between the autologous umbilical cord blood stem cells recipients and control group
次要结局
- effect of autologous umbilical cord blood stem cells infusion in enrolled preterm infants(1 year)
研究者
yangjie
Professor
Guangdong Women and Children Hospital