Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 8, 2023

Primary Completion Date

March 8, 2031

Study Completion Date

September 8, 2036

Conditions
Spina Bifida; FetusMyelomeningoceleMyeloschisis
Interventions
DEVICE

NEOX Cord 1K applied fetoscopically

Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (human umbilical cord) will be used for skin closure at the discretion of the Pediatric Neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.

Trial Locations (1)

77030

RECRUITING

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

The University of Texas Health Science Center, Houston

OTHER