Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair
Recruiting now · Not applicable
Conditions studied: Spina Bifida; Fetus, Myelomeningocele, Myeloschisis
In brief
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.
Key facts
- Study ID
- NCT06042140
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 100
- Starts
- 2023-09-08
- Expected to finish
- 2036-09-08
- Last updated by the study team
- 2025-08-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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 ≤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
- 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 a normal chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance [fluorescence in situ hybridization (FISH) acceptable if ≥ 24 weeks].
You may not qualify if…
- Maternal Exclusion Criteria:
- 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
- Fetal exclusion criteria:
- Major fetal anomaly not related to spina bifida
- Kyphosis in the fetus of 30 degrees or more
Where it is running
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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