Actively Recruiting
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
Led by The University of Texas Health Science Center, Houston · Updated on 2025-09-12
15
Participants Needed
1
Research Sites
386 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Willingness by legally authorized representative to comply with all study procedures and be available for the study duration
- Maternal age 18 years and older
- Mother is English or Spanish speaking
You will not qualify if you...
- 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 deemed unnecessary
- Umbilical cord abnormality
- Insufficient autologous cord tissue or patch
- Autologous umbilical cord patch not meeting laboratory safety standards per SOP
- Treatment with an investigational drug or other intervention that could influence morbidity or mortality
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Stephen Fletcher, DO
CONTACT
C
Caroline Doughty
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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