RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-05
Study Completion:2033-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06929572

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 24 Hours
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Neonates born with prenatal diagnosis of open neural tube defect (myelomeningocele or myeloschisis)
  2. * Resident of the United States
  3. * Provision of signed and dated informed consent form
  4. * Stated willingness by legally authorized representative (LAR) to comply with all study procedures and availability for the duration of the study
  5. * Maternal age 18 years and older
  6. * Mother is English or Spanish Speaking
  1. * Sepsis or signs of infection of the neonate
  2. * Febrile or other acute illness of the neonate at time of delivery
  3. * Major congenital anomaly unrelated to spina bifida that may impact safety of neonate for surgery
  4. * Evidence of intra-amniotic or maternal infection related to pregnancy at time of delivery
  5. * Maternal use of steroid therapy during pregnancy or neonate use of steroid therapy,except for lung maturity indications
  6. * Vaginal delivery
  7. * Patch closure of dura is deemed unnecessary
  8. * Umbilical cord abnormality
  9. * Insufficient autologous cord tissue or patch
  10. * Autologous umbilical cord patch that does not meet laboratory safety standards per standard operating procedure (SOP)
  11. * Treatment with an investigational drug or other intervention that would influence morbidity or mortality

Contacts and Locations

Study Contact

Stephen Fletcher, DO
CONTACT
(713) 500-7308
Stephen.Fletcher@uth.tmc.edu
Caroline Doughty
CONTACT
713-500-7481
Caroline.Doughty@uth.tmc.edu

Principal Investigator

Stephen Fletcher, DO
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Stephen Fletcher, DO, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-05
Study Completion Date2033-01

Study Record Updates

Study Start Date2025-08-05
Study Completion Date2033-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Spina Bifida