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
The University of Texas Health Science Center, Houston
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator