NCT06929572 · The University of Texas Health Science Center, Houston
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 12, 2025 · Source of record for eligibility and locations