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NCT Number: NCT06929572

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

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.

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Key information

Conditions

Spina Bifida Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Meningomyelocele Nervous System Diseases Nervous System Malformations Neural Tube Defects Spinal Dysraphism

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous umbilical cord patch

Procedure

Surgery 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.

Primary outcomes

  1. Number of participants that have wound dehiscence

    Time frame: one-month post-op

  2. Number of participants that have wound dehiscence

    Time frame: 1-year post-op

  3. Number of participants that have Cerebrospinal fluid (CSF) leakage

    Time frame: one-month post-op

  4. Number of participants that have CSF leakage

    Time frame: 1-year post-op.

Secondary outcomes

  1. Number of participants that present with tethered cord syndrome

    Time frame: one-month post-op,12-months post-op, 30-months post-op, and 60-months post-op

  2. Number of participants that had a change in level of neurological function as assessed by the American Spinal Injury Association Impairment Scale (ASIA)

    Time frame: baseline, one-month post-op,12-months post-op

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Doughty

CONTACT

[email protected]

713-500-7481

Stephen Fletcher, DO

CONTACT

[email protected]

(713) 500-7308

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2033
First posted
Apr 16, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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