The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
赞助:
Guangdong Women and Children Hospital
合作者:
信息的提供 (责任方):
yangjie，Guangdong Women and Children Hospital
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 3, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | November 1, 2018 | ||
| 预计主要完成日期 | September 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants[ Time Frame: 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 |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells | ||
| 正式标题 ICMJE | The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells | ||
| 简要概况 | To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury |
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| 详细说明 | 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. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 1 | ||
| 研究设计 ICMJE | 分配: Non-Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
200 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 1, 2021 | ||
| 预计主要完成日期 | September 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - 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. Exclusion Criteria: - 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. | ||
| 性别 |
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| 年龄 | 最小年龄：28 Weeks ，最大年龄：37 Weeks | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | yangjie，Guangdong Women and Children Hospital | ||
| 研究赞助商 ICMJE | Guangdong Women and Children Hospital | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Guangdong Women and Children Hospital | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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