ClinicalTrials.gg
RecruitingNCT06929572Updated Sep 24, 2026

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

An interventional study of Autologous umbilical cord patch in Spina Bifida, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
Up to 24 Hours
Sex
All
01

Study summary

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.

02

Conditions studied

  • Spina Bifida

Keywords

  • open neural tube defects
  • autologous umbilical cord patch
  • myelomeningocele
  • myeloschisis
03

In context

Spinal Dysraphism

142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.

This study's planned enrollment of 15 is below the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.

Browse Spinal Dysraphism studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 24 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 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 drug or other intervention that would influence morbidity or mortality
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Autologous umbilical cord patch

    Procedure: Autologous umbilical cord patch

Interventions

  • ProcedureAutologous 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.

06

What researchers measure

Primary outcomes

  1. Number of participants that have wound dehiscence

    Time frame: one-month post-op

  2. Number of participants that have wound dehiscence

    Time frame: 1-year post-op

  3. Number of participants that have Cerebrospinal fluid (CSF) leakage

    Time frame: one-month post-op

  4. Number of participants that have CSF leakage

    Time frame: 1-year post-op.

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Jul 2028, 35 months after the start.

Of 60 non-industry interventional studies with no phase under Spinal Dysraphism, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's planned 35 months is above that.

Counting every sponsor, half of 62 studies reached it within 31 months; a quarter within 20 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2025
First posted
Apr 16, 2025
StartActual
Aug 5, 2025
Primary completionEst.
Jul 2028
CompletionEst.
Jan 2033
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06929572
Responsible party
Stephen Fletcher (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Apr 16, 2025
Start date
Aug 5, 2025
Primary completion
Jul 2028 (estimated)
Completion
Jan 2033 (estimated)
Last update
Sep 24, 2026

Study contacts

Stephen Fletcher, DO
Contact
Stephen.Fletcher@uth.tmc.edu
(713) 500-7308
Caroline Doughty
Contact
Caroline.Doughty@uth.tmc.edu
713-500-7481
Stephen Fletcher, DO
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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