Autologous umbilical cord patch for closing open spinal defects after birth
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
This trial tests whether using a newborn's own umbilical cord tissue to close the dura can improve repair in babies born with open neural tube defects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | N/A to 24 Hours |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06929572 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study applies an autologous umbilical cord tissue patch at postnatal surgery to close the dura in neonates with prenatally diagnosed myelomeningocele or myeloschisis. Primary outcomes compared to historical controls include successful defect closure, enlargement of the spinal canal space, and reduction in inflammatory tissue response. Eligibility requires maternal consent, US residency, maternal age ≥18, English or Spanish speaking, and absence of infection, major unrelated anomalies, steroid exposure beyond lung-maturity indications, vaginal delivery, or umbilical cord abnormalities. Procedures and follow-up are performed at The University of Texas Health Science Center at Houston with surgical outcomes and tissue responses tracked postoperatively.
Who should consider this trial
Good fit: Newborns with a prenatal diagnosis of myelomeningocele or myeloschisis whose families consent, are US residents, and meet the surgery and cord-tissue eligibility criteria are ideal candidates.
Not a fit: Babies with neonatal or maternal infection, major unrelated congenital anomalies, maternal or neonatal steroid exposure outside lung-maturity use, umbilical cord abnormalities, vaginal delivery, or insufficient cord tissue are unlikely to receive benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could improve dural sealing, reduce scarring and inflammation, and lead to more durable surgical repairs for babies with open neural tube defects.
How similar studies have performed: The use of autologous umbilical cord for dural repair is relatively novel with limited prior data and primarily small series or historical comparisons rather than large randomized trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Fletcher, DO — The University of Texas Health Science Center, Houston
- Study coordinator: Stephen Fletcher, DO
- Email: Stephen.Fletcher@uth.tmc.edu
- Phone: (713) 500-7308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.