Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects

The University of Texas System (UT)

Status

Enrolling

Conditions

Spina Bifida

Treatments

Procedure: Autologous umbilical cord patch

Study type

Interventional

Funder types

Other

Identifiers

NCT06929572

HSC-MS-24-1194

Details and patient eligibility

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.

Enrollment

15 estimated patients

Sex

All

Ages

Under 24 hours old

Volunteers

No Healthy Volunteers

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