Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair: Single Arm Phase III Trial.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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 \[fluorescence in situ hybridization (FISH) acceptable if ≥ 24 weeks\].

Locations
United States
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Ramesha Papanna, MD, MPH
Ramesha.Papanna@uth.tmc.edu
(713) 500-6423
Backup
Stephanie W Conaway, BSN
Stephanie.L.Whitney@uth.tmc.edu
(713) 486-6558
Time Frame
Start Date: 2023-09-08
Estimated Completion Date: 2036-09-08
Participants
Target number of participants: 100
Treatments
Experimental: NEOX Cord 1K applied fetoscopically
Patients intending to undergo open in-utero spina bifida repair will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Pediatric Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled.
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov

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