Using an Autologous Umbilical Cord Tissue Patch to Close Open Neural Tube Defects in Newborns with Spina Bifida

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.

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