Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair
Recruiting
N/A
Interventional Study
Spina Bifida; Fetus
Myelomeningocele
Myeloschisis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- The University of Texas Health Science Center, Houston · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Maternal Inclusion Criteria:
1. Singleton pregnancy
2. Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks
3. Maternal age: 18 years and older
4. Body mass index ≤45 kg/m2 (pre-pregnancy)
5. No preterm birth risk factors (shor…
Contacts