Status:
RECRUITING
Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Spina Bifida; Fetus
Myelomeningocele
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Maternal
- 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
- 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
- Maternal
Key Trial Info
Start Date :
September 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 8 2036
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06042140
Start Date
September 8 2023
End Date
September 8 2036
Last Update
August 13 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030