Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair: Single Arm Phase III Trial.
The University of Texas Health Science Center, Houston
Summary
The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: Maternal Inclusion Criteria: 1. Singleton pregnancy 2. Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks 3. Maternal age: 18 years and older 4. Body mass index ≤45 kg/m2 (pre-pregnancy) 5. No preterm birth risk factors (short cervix \<20 mm or a history of previous preterm delivery) 6. No previous uterine incision in the active uterine segment 7. Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful Fetal Inclusion Criteria: 1. Spina bifida defect between T1 to S1 vertebral levels 2. Chia…
Interventions
- DeviceNEOX 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.
Location
- The University of Texas Health Science Center at HoustonHouston, Texas