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

September 5, 2025 updated by: Stephen Fletcher, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Neonates born with prenatal diagnosis of open neural tube defect (myelomeningocele or myeloschisis)
  • Resident of the United States
  • Provision of signed and dated informed consent form
  • Stated willingness by legally authorized representative (LAR) to comply with all study procedures and availability for the duration of the study
  • Maternal age 18 years and older
  • Mother is English or Spanish Speaking

Exclusion Criteria:

  • Sepsis or signs of infection of the neonate
  • Febrile or other acute illness of the neonate at time of delivery
  • Major congenital anomaly unrelated to spina bifida that may impact safety of neonate for surgery
  • Evidence of intra-amniotic or maternal infection related to pregnancy at time of delivery
  • Maternal use of steroid therapy during pregnancy or neonate use of steroid therapy,except for lung maturity indications
  • Vaginal delivery
  • Patch closure of dura is deemed unnecessary
  • Umbilical cord abnormality
  • Insufficient autologous cord tissue or patch
  • Autologous umbilical cord patch that does not meet laboratory safety standards per standard operating procedure (SOP)
  • Treatment with an investigational drug or other intervention that would influence morbidity or mortality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous umbilical cord patch
Procedure: Autologous umbilical cord patch
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants that have wound dehiscence
Time Frame: one-month post-op
one-month post-op
Number of participants that have wound dehiscence
Time Frame: 1-year post-op
1-year post-op
Number of participants that have Cerebrospinal fluid (CSF) leakage
Time Frame: one-month post-op
one-month post-op
Number of participants that have CSF leakage
Time Frame: 1-year post-op.
1-year post-op.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants that present with tethered cord syndrome
Time Frame: one-month post-op,12-months post-op, 30-months post-op, and 60-months post-op
one-month post-op,12-months post-op, 30-months post-op, and 60-months post-op
Number of participants that had a change in level of neurological function as assessed by the American Spinal Injury Association Impairment Scale (ASIA)
Time Frame: baseline, one-month post-op,12-months post-op
baseline, one-month post-op,12-months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Stephen Fletcher, DO, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

January 1, 2033

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-24-1194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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