NCT06929572 Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
| NCT ID | NCT06929572 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Spina Bifida |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-08-05 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-08-05 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Stephen Fletcher, DO
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT06929572 clinical trial?
This trial is open to participants of all sexes, up to 24 Hours, studying Spina Bifida. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06929572 currently recruiting?
Yes, NCT06929572 is actively recruiting participants. Contact the research team at Stephen.Fletcher@uth.tmc.edu for enrollment information.
Where is the NCT06929572 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06929572 clinical trial?
NCT06929572 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Stephen Fletcher, DO at The University of Texas Health Science Center, Houston. The trial plans to enroll 15 participants.