BridgeMD
New treatment option for Spina Bifida
Official title Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
ClinicalTrials.gov ID: NCT06929572
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 24
You may be able to join 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
You likely 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 24 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.