NCT06042140招募中不适用
Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair: Single Arm Phase III Trial.
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of participants that can ambulate independently by walking at least 10 steps
研究概览
简要总结
The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal Inclusion Criteria:
- •Singleton pregnancy
- •Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks
- •Maternal age: 18 years and older
- •Body mass index ≤45 kg/m2 (pre-pregnancy)
- •No preterm birth risk factors (short cervix <20 mm or a history of previous preterm delivery)
- •No previous uterine incision in the active uterine segment
- •Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful
- •Fetal Inclusion Criteria:
- •Spina bifida defect between T1 to S1 vertebral levels
- •Chiari II malformation
- •No evidence of kyphosis (curved spine)
- •No major life-threatening fetal anomaly unrelated to spina bifida
- •Normal karyotype, or a normal chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance [fluorescence in situ hybridization (FISH) acceptable if ≥ 24 weeks].
排除标准
- •Maternal Exclusion Criteria:
- •Non-resident of the United States
- •Multifetal pregnancy
- •Poorly controlled insulin-dependent pregestational diabetes
- •Poorly controlled A2 diabetes mellitus (A2DM) insulin-dependent diabetes
- •Current or planned cerclage or documented history of an incompetent cervix
- •Placenta previa or placental abruption
- •Short cervix of < 20 mm
- •Obesity as defined by a body mass index of > 45 kg/m2
- •Previous spontaneous singleton delivery prior to 37 weeks
- •Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal alloimmune thrombocytopenia
- •HIV or Hepatitis-B positive status
- •Known Hepatitis-C positivity
- •Uterine anomaly such as large or multiple fibroids or a mullerian duct abnormality that is diagnosed via imaging prior to surgery, which that are unavoidable during surgery
- •Other medical conditions which are contraindication to surgery or general anesthesia
- •Patient does not have a support person
- •Inability to comply with the travel and follow-up requirements of the trial
- •Patient does not meet psychosocial standardized assessment criteria
- •Participation in this or another intervention study that influences maternal and fetal morbidity and mortality
- •Maternal hypertension
- •Zika virus positivity
- •Allergy/history of drug reaction to Amphotericin B
- •Fetal exclusion criteria:
- •Major fetal anomaly not related to spina bifida
- •Kyphosis in the fetus of 30 degrees or more
- •Ventriculomegaly greater than 15 mm and no movements noted at hip and knee joints
结局指标
主要结局
Number of participants that can ambulate independently by walking at least 10 steps
时间窗: 30-36 months after delivery
次要结局
- Number of participants with lower extremity motor and sensory levels exceeding the anatomical level of the lesion by ≥ 2 segments(30-36 months after delivery)
研究者
Ramesha Papanna
Professor
The University of Texas Health Science Center, Houston
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Fetoscopic NEOX Cord 1K® Spina Bifida RepairMyelomeningoceleMyeloschisisSpina BifidaNCT04243889The University of Texas Health Science Center, Houston100
已完成
1 期
Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage DefectCartilage DiseasesOsteoarthritisNCT02291926Shenzhen Hornetcorn Bio-technology Company, LTD20
Unknown
1 期
Human Umbilical Cord-Mesenchymal Stem Cells for PneumoconiosisPneumoconiosisNCT02790762Shenzhen Hornetcorn Bio-technology Company, LTD10
Unknown
2 期
Intracavitary Injection of hUMSCs in Acute Basal Ganglia Hematoma After Stereotactic AspirationBasal Ganglia HematomaNCT04074408Second Affiliated Hospital, School of Medicine, Zhejiang University100
撤回
1 期
Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19COVID-19Corona Virus InfectionAcute Respiratory Distress SyndromeNCT04490486Joshua M Hare