Clinical trial NCT06929572: Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
Official title: Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spina Bifida
Keywords: open neural tube defects
autologous umbilical cord patch
myelomeningocele
myeloschisis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 15
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of participants that have wound dehiscence
timeFrame: one-month post-op
measure: Number of participants that have wound dehiscence
timeFrame: 1-year post-op
measure: Number of participants that have Cerebrospinal fluid (CSF) leakage
timeFrame: one-month post-op
measure: Number of participants that have CSF leakage
timeFrame: 1-year post-op.
Secondary outcomes:
measure: Number of participants that present with tethered cord syndrome
timeFrame: one-month post-op,12-months post-op, 30-months post-op, and 60-months post-op
measure: Number of participants that had a change in level of neurological function as assessed by the American Spinal Injury Association Impairment Scale (ASIA)
timeFrame: baseline, one-month post-op,12-months post-op
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Stephen Fletcher, DO
role: PRINCIPAL_INVESTIGATOR
References: