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.
Singleton pregnancy
Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks
Maternal age: 18 years and older
Body mass index ≤45 kg/m2 (pre-pregnancy)
Non-resident of the United States
Multifetal pregnancy
Poorly controlled insulin-dependent pregestational diabetes
Poorly controlled A2 diabetes mellitus (A2DM) insulin-dependent diabetes
Single group
NEOX Cord 1K applied fetoscopically
DeviceUnder 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.
Number of participants that can ambulate independently by walking at least 10 steps
Number of participants with lower extremity motor and sensory levels exceeding the anatomical level of the lesion by ≥ 2 segments
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The University of Texas Health Science Center, Houston
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
