NCT06929572招募中不适用
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年8月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of participants that have wound dehiscence
研究概览
简要总结
The purpose of this study is to determine the impact of an autologous umbilical cord patch for dural closure on the repair of open neural tube defect. The outcomes will evaluate successful defect closure, creation of a more capacious spinal canal, and reduction in inflammatory tissue response versus historical controls.
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
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates born with prenatal diagnosis of open neural tube defect (myelomeningocele or myeloschisis)
- •Resident of the United States
- •Provision of signed and dated informed consent form
- •Stated willingness by legally authorized representative (LAR) to comply with all study procedures and availability for the duration of the study
- •Maternal age 18 years and older
- •Mother is English or Spanish Speaking
排除标准
- •Sepsis or signs of infection of the neonate
- •Febrile or other acute illness of the neonate at time of delivery
- •Major congenital anomaly unrelated to spina bifida that may impact safety of neonate for surgery
- •Evidence of intra-amniotic or maternal infection related to pregnancy at time of delivery
- •Maternal use of steroid therapy during pregnancy or neonate use of steroid therapy,except for lung maturity indications
- •Vaginal delivery
- •Patch closure of dura is deemed unnecessary
- •Umbilical cord abnormality
- •Insufficient autologous cord tissue or patch
- •Autologous umbilical cord patch that does not meet laboratory safety standards per standard operating procedure (SOP)
- •Treatment with an investigational drug or other intervention that would influence morbidity or mortality
结局指标
主要结局
Number of participants that have wound dehiscence
时间窗: 1-year post-op
Number of participants that have Cerebrospinal fluid (CSF) leakage
时间窗: one-month post-op
Number of participants that have CSF leakage
时间窗: 1-year post-op.
次要结局
- Number of participants that present with tethered cord syndrome(one-month post-op,12-months post-op, 30-months post-op, and 60-months post-op)
- Number of participants that had a change in level of neurological function as assessed by the American Spinal Injury Association Impairment Scale (ASIA)(baseline, one-month post-op,12-months post-op)
研究者
Stephen Fletcher
Professor
The University of Texas Health Science Center, Houston
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Cytokines Associated With Cord Blood Cell Therapy for Neonatal EncephalopathyNeonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)NCT02455830Neonatal Encephalopathy Consortium, Japan18
Unknown
1 期
Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid ArthritisRheumatoid ArthritisNCT01985464Translational Biosciences20
进行中（未招募）
不适用
Human stem cell therapy for acute respiratory distress syndromeISRCTN47911040Chang Gung Memorial Hospital60
已完成
不适用
Study of Human Umbilical Cord-derived Mesenchymal Stem Cells for Treatment of Refractory Immune ThrombocytopeniaMesenchymal Stem CellsThrombocytopeniaNCT04014166Institute of Hematology & Blood Diseases Hospital, China18
已完成
1 期
Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple SclerosisMultiple SclerosisNCT02034188Translational Biosciences20