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NCT06929572From ClinicalTrials.govRecruiting

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

  • Spina Bifida

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
The University of Texas Health Science Center, Houston
Enrolment target
15
Started
5 August 2025
Main results due
July 2028
Study sites
1
Registry updated
24 September 2026

Can you take part?

  • Up to 24 hours.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • The University of Texas Health Science Center at Houston

    Houston, Texas, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06929572. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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