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

NCT06929572 | Recruiting

• 1 other identifier: HSC-MS-24-1194
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Number of participants that have wound dehiscence

  one-month post-op

• Number of participants that have wound dehiscence

  1-year post-op

• Number of participants that have Cerebrospinal fluid (CSF) leakage

  one-month post-op

• Number of participants that have CSF leakage

  1-year post-op.

Secondary Outcomes (2)

• Number of participants that present with tethered cord syndrome

  one-month post-op,12-months post-op, 30-months post-op, and 60-months post-op

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

  baseline, one-month post-op,12-months post-op

Study Arms (1)

Autologous umbilical cord patch

EXPERIMENTAL

Procedure: Autologous umbilical cord patch

Interventions

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.

Autologous umbilical cord patch

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Spinal Dysraphism; Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Stephen Fletcher, DO

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Fletcher, DO

CONTACT

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

Caroline Doughty

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 16, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2033
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)