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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help babies born with a condition called spina bifida, which is caused by an open neural tube defect. The researchers want to see if using a patch made from the baby’s own umbilical cord can improve the closure of the defect in the spine, make the spinal canal larger, and reduce inflammation compared to past treatments. This trial is not yet recruiting participants, but it aims to include newborns (up to 1 month old) diagnosed with this condition before their birth.

To be eligible for the study, the baby must be a resident of the United States, and their mother must be at least 18 years old and speak either English or Spanish. The mother also needs to agree to follow all study procedures. However, certain factors may exclude a baby from participation, such as signs of infection at birth or if the baby has other serious health issues. If your baby is eligible, participating in this trial could provide a chance to help improve treatment for spina bifida.

Gender

ALL

Eligibility criteria

• 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 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