Fetoscopic NEOX Cord 1K® Spina Bifida Repair
Spina Bifida, Myelomeningocele, Myeloschisis
About this trial
This is an interventional treatment trial for Spina Bifida focused on measuring Neox Cord 1K, Fetoscopic repair, Cryopreserved human umbilical cord
Eligibility Criteria
Inclusion Criteria:
Maternal inclusion criteria:
- 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 < 40 kg/m2
- No preterm birth risk factors (short cervix, history of previous preterm delivery)
- No previous uterine incision in the active uterine segment
- Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful
Fetal inclusion criteria:
- Spina bifida defect between T1 to S1 vertebral levels
- Chiari II malformation
- No evidence of kyphosis (curved spine)
- No major life-threatening fetal anomaly unrelated to spina bifida
- Normal karyotype, or normal CMA, or a CMA with variants of unknown significance
Exclusion Criteria:
Maternal exclusion criteria:
- Non-resident of the United States
- Multifetal pregnancy
- Poorly controlled insulin-dependent pregestational diabetes
- Poorly controlled A2DM insulin-dependent diabetes
- Current or planned cerclage or documented history of an incompetent cervix
- Placenta previa or placental abruption
- Short cervix of < 20 mm
- Obesity as defined by a body mass index of > 40 kg/m2
- Previous spontaneous singleton delivery prior to 37 weeks
- Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal alloimmune thrombocytopenia
- HIV or Hepatitis-B positive status
- Known Hepatitis-C positivity
- Uterine anomaly such as large or multiple fibroids or a mullerian duct abnormality that is diagnosed via imaging prior to surgery, which that are unavoidable during surgery
- Other medical conditions which are contraindication to surgery or general anesthesia
- Patient does not have a support person
- Inability to comply with the travel and follow-up requirements of the trial
- Patient does not meet psychosocial standardized assessment criteria
- Participation in this or another intervention study that influences maternal and fetal morbidity and mortality
- Maternal hypertension
- Zika virus positivity
- Allergy/history of drug reaction to Amphotericin B
Fetal exclusion criteria:
- Major fetal anomaly not related to spina bifida
- Kyphosis in the fetus of 30 degrees or more
- Ventriculomegaly greater than 15 mm and no movements noted at hip and knee joints
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Experimental
NEOX Cord 1K applied fetoscopically
Patients intending to undergo open in-utero spina bifida repair, will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled.