Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06042140
Status
Recruiting
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Conditions

  • Myelomeningocele
  • Myeloschisis
  • Spina Bifida; Fetus

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NEOX Cord 1K applied fetoscopically — DEVICE
    Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (human umbilical cord) will be used for skin closure at the discretion of the Pediatric Neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.

Study Details

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 Dates

Start date
Sep 8, 2023
Status verified
Aug 2025
Primary completion
Mar 8, 2031
Completion
Sep 8, 2036

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number of participants that can ambulate independently by walking at least 10 steps [ Time Frame: 30-36 months after delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Ramesha Papanna, MD, MPH
[email protected]
713-500-6423
Stephanie W Conaway, BSN
[email protected]
(713) 486-6558
Ramesha Papanna, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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