Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects

ConditionSpina Bifida
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 24
SponsorThe University of Texas Health Science Center, Houston

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Autologous umbilical cord patch

Treatment groups

15 Participants
are divided into 1 treatment group