Autologous umbilical cord patch for closing open spinal defects after birth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional study applies an autologous umbilical cord tissue patch at postnatal surgery to close the dura in neonates with prenatally diagnosed myelomeningocele or myeloschisis. Primary outcomes compared to historical controls include successful defect closure, enlargement of the spinal canal space, and reduction in inflammatory tissue response. Eligibility requires maternal consent, US residency, maternal age ≥18, English or Spanish speaking, and absence of infection, major unrelated anomalies, steroid exposure beyond lung-maturity indications, vaginal delivery, or umbilical cord abnormalities. Procedures and follow-up are performed at The University of Texas Health Science Center at Houston with surgical outcomes and tissue responses tracked postoperatively.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Stephen Fletcher, DO — The University of Texas Health Science Center, Houston
• Study coordinator: Stephen Fletcher, DO
• Email: Stephen.Fletcher@uth.tmc.edu
• Phone: (713) 500-7308

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.