What this study is
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.
What's being tested
- Autologous umbilical cord patch
Intervention · 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.
Study details
- Sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Spina Bifida
- Enrolling
- 15 people
- Starts
- 2025-08-05
- Est. completion
- 2033-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 24 HoursSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe University of Texas Health Science Center at Houston
Houston, Texas, United States
- Stephen Fletcher, DO · Contact713-500-7308Stephen.Fletcher@uth.tmc.edu
- Caroline Doughty · Contact713-500-7481Caroline.Doughty@uth.tmc.edu
Recruiting
Study team
Sponsor
The University of Texas Health Science Center, Houston
Study ID HSC-MS-24-1194
Principal investigator
Stephen Fletcher, DO
The University of Texas Health Science Center, Houston
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.