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.
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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

Ramesha Papanna, MD, MPH

(713) 500-6423

Ramesha.Papanna@uth.tmc.edu

CONTACT

Stephanie W Conaway, BSN

(713) 486-6558

Stephanie.L.Whitney@uth.tmc.edu

CONTACT