Recruiting

Autologous Umbilical Cord

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06929572

Conditions

Spina Bifida

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Autologous umbilical cord patch

Study Details

Brief summary:

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.

Conditions

Spina Bifida

Study ID

NCT06929572

Start date

Aug 5, 2025

Status verified date

Sep, 2025

Completion date

Jan, 2033

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Autologous umbilical cord patch

Interventions

Autologous umbilical cord patch

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 outcome measure

  • Number of participants that have wound dehiscence [ Time Frame: one-month post-op ]
  • Number of participants that have wound dehiscence [ Time Frame: 1-year post-op ]
  • Number of participants that have Cerebrospinal fluid (CSF) leakage [ Time Frame: one-month post-op ]
  • Number of participants that have CSF leakage [ Time Frame: 1-year post-op. ]

Central Contacts and Locations

Central contacts

Stephen Fletcher, DO

(713) 500-7308Stephen.Fletcher@uth.tmc.edu

Caroline Doughty

713-500-7481Caroline.Doughty@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Stephen Fletcher, DO

713-500-7308Stephen.Fletcher@uth.tmc.edu

Caroline Doughty

713-500-7481Caroline.Doughty@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Keywords

  • open neural tube defects
  • autologous umbilical cord patch
  • myelomeningocele
  • myeloschisis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-09-12.