Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair
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
100 participants
Sep 8, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- 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)
- No preterm birth risk factors (short cervix <20 mm or a 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
- 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 a normal chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance \[fluorescence in situ hybridization (FISH) acceptable if ≥ 24 weeks\].
Exclusion Criteria24
- Non-resident of the United States
- Multifetal pregnancy
- Poorly controlled insulin-dependent pregestational diabetes
- Poorly controlled A2 diabetes mellitus (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 > 45 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
- 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
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Interventions
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.
Locations(1)
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NCT06042140