Status:
RECRUITING
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Spina Bifida
Eligibility:
All Genders
Up to 24 years
Phase:
NA
Brief Summary
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 clos...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2033
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06929572
Start Date
August 5 2025
End Date
January 1 2033
Last Update
September 12 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030