Actively Recruiting
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
Led by The University of Texas Health Science Center, Houston · Updated on 2025-09-12
15
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of using an autologous umbilical cord tissue patch for closing open neural tube defects in newborns diagnosed prenatally with conditions such as myelomeningocele or myeloschisis. The study aims to assess how well this patch repairs the defect, increases the spinal canal space, and reduces inflammatory tissue response compared to past treatments. This investigational procedure is sponsored by The University of Texas Health Science Center, Houston. The treatment involves harvesting umbilical cord tissue at birth and immediately processing it to create a dural patch that covers the spinal cord defect within a few hours after delivery. Surgery is performed within 24 hours of birth to close the developmental defect using this patch. This approach is being studied as a new surgical option for postnatal repair of open neural tube defects. Participants will be closely monitored after surgery for wound healing complications such as wound opening and cerebrospinal fluid leakage at one month and one year post-operation. Additional evaluations include tracking the development of tethered cord syndrome and changes in neurological function over a period extending to five years. The study requires signed consent and ongoing participation with several follow-up assessments to measure safety and efficacy outcomes.
CONDITIONS
Brief Title
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Willingness by legally authorized representative to comply with all study procedures and availability for study duration
- Maternal age 18 years and older
- Mother is English or Spanish speaking
You will not qualify if you...
- 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 impacting neonate safety for surgery
- Evidence of intra-amniotic or maternal infection related to pregnancy at delivery
- Maternal or neonate use of steroid therapy except for lung maturity indications
- Vaginal delivery
- Patch closure of dura deemed unnecessary
- Umbilical cord abnormality
- Insufficient autologous cord tissue or patch
- Patch not meeting laboratory safety standards per SOP
- Treatment with investigational drug or intervention influencing morbidity or mortality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From birth to 24 hours for surgery, with immediate post-operative period following
Participants undergo surgery within 24 hours after birth where an autologous umbilical cord patch is harvested and used to close the neural tube defect. Immediate post-operative care follows the surgery.
1 surgery visit and immediate post-operative period
Duration - Up to 60 months after surgery
Participants are monitored for wound healing, neurological function, and potential complications such as cerebrospinal fluid leakage and tethered cord syndrome.
Visits at 1 month, 12 months, 30 months, and 60 months post-operation
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Stephen Fletcher, DO
C
Caroline Doughty
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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