Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
The University of Texas Health Science Center, Houston
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 closure, creation of a more capacious spinal canal, and reduction in inflammatory tissue response versus historical controls.
Eligibility
- Age range
- Up to 24 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * Sepsis or signs of infection of the neonate * Febrile or other acute illness of the neonate at time of delivery * Major congenital anomaly unrelat…
Interventions
- ProcedureAutologous umbilical cord patch
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.
Location
- The University of Texas Health Science Center at HoustonHouston, Texas