[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587529":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":32,"responsibleParty":51,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":11,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Autologous umbilical cord patch","EXPERIMENTAL",null,[13],"Procedure: Autologous umbilical cord patch",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"PROCEDURE","Surgery will occur from birth to 24 hours of age. The autologous umbilical cord patch is harvested at time of delivery and immediately processed in a sterile setting in order to create a dural patch as a spinal cord cover to close the developmental defect within a few hours after birth.",[9],[20],{"name":21,"affiliation":5,"role":22},"Stephen Fletcher, DO","PRINCIPAL_INVESTIGATOR",[24,28],{"name":21,"role":25,"phone":26,"phoneExt":11,"email":27},"CONTACT","(713) 500-7308","Stephen.Fletcher@uth.tmc.edu",{"name":29,"role":25,"phone":30,"phoneExt":11,"email":31},"Caroline Doughty","713-500-7481","Caroline.Doughty@uth.tmc.edu",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"The University of Texas Health Science Center at Houston","RECRUITING","Houston","Texas","77030","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-95.36327,29.76328,{"lat":45,"lon":44},[48,50],{"name":21,"role":25,"phone":49,"phoneExt":11,"email":27},"713-500-7308",{"name":29,"role":25,"phone":30,"phoneExt":11,"email":31},{"type":22,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Stephen Fletcher","Professor","100587529","autologous-human-umbilical-cord-tissue-patch-for-postnatal-closure-of-open-neural-tube-defects-100587529",false,"NCT06929572","Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects","Inclusion Criteria:\n\n* Neonates born with prenatal diagnosis of open neural tube defect (myelomeningocele or myeloschisis)\n* Resident of the United States\n* Provision of signed and dated informed consent form\n* Stated willingness by legally authorized representative (LAR) to comply with all study procedures and availability for the duration of the study\n* Maternal age 18 years and older\n* Mother is English or Spanish Speaking\n\nExclusion Criteria:\n\n* Sepsis or signs of infection of the neonate\n* Febrile or other acute illness of the neonate at time of delivery\n* Major congenital anomaly unrelated to spina bifida that may impact safety of neonate for surgery\n* Evidence of intra-amniotic or maternal infection related to pregnancy at time of delivery\n* Maternal use of steroid therapy during pregnancy or neonate use of steroid therapy,except for lung maturity indications\n* Vaginal delivery\n* Patch closure of dura is deemed unnecessary\n* Umbilical cord abnormality\n* Insufficient autologous cord tissue or patch\n* Autologous umbilical cord patch that does not meet laboratory safety standards per standard operating procedure (SOP)\n* Treatment with an investigational drug or other intervention that would influence morbidity or mortality","ALL","24 Hours",{"count":63,"type":64},15,"ESTIMATED","INTERVENTIONAL",[67],"NA","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.",[70],"Spina Bifida",[72,73,74,75],"open neural tube defects","autologous umbilical cord patch","myelomeningocele","myeloschisis","2025-09-05",{"date":78,"type":79},"2025-09-12","ACTUAL",{"date":81,"type":79},"2025-08-05",{"date":83,"type":64},"2033-01",{"name":5,"class":6},1]