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.
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
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
Single group
Autologous umbilical cord patch
Procedure/SurgerySurgery 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.
Number of participants that have wound dehiscence
Number of participants that have wound dehiscence
Number of participants that have Cerebrospinal fluid (CSF) leakage
Number of participants that have CSF leakage
Number of participants that present with tethered cord syndrome
Number of participants that had a change in level of neurological function as assessed by the American Spinal Injury Association Impairment Scale (ASIA)
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