Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06929572
Status
Recruiting
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Conditions

  • Spina Bifida

Eligibility Criteria

Sex
ALL
Age
N/A - 24 Hours
Healthy Volunteers
Not accepted

Interventions

  • Autologous umbilical cord patch — PROCEDURE
    Surgery will occur from birth to 24 hours of age. The autologous umbilical cord patch is harvested at time of delivery and immediately processed in a sterile setting in order to create a dural patch as a spinal cord cover to close the developmental defect within a few hours after birth.

Study Details

The purpose of this study is to determine the impact of an autologous umbilical cord patch for dural closure on the repair of open neural tube defect. The outcomes will evaluate successful defect closure, creation of a more capacious spinal canal, and reduction in inflammatory tissue response versus historical controls.

Key Dates

Start date
Aug 5, 2025
Status verified
Sep 2025
Primary completion
Jul 31, 2028
Completion
Jan 31, 2033

Study Design

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

Arms

  • Experimental: Autologous umbilical cord patch

Primary Outcome Measure

Number of participants that have wound dehiscence [ Time Frame: one-month post-op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Stephen Fletcher, DO
[email protected]
713-500-7308
Caroline Doughty
[email protected]
713-500-7481

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

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