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Baby's own cord tissue used to patch spinal defect in promising new trial

NCT ID NCT06929572

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new surgical approach for newborns with spina bifida, where a patch made from the baby's own umbilical cord is used to cover the spinal defect shortly after birth. The goal is to see if this method reduces complications like wound breakdown and fluid leakage compared to standard care. Fifteen infants will be enrolled and followed for outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous umbilical cord patch
What this could lead to
If successful, this could offer a safer, more effective way to repair spinal defects in newborns with spina bifida, potentially reducing complications like spinal cord tethering.
What could go wrong
This is a very small early-stage trial with only 15 participants, so results may not apply to all. Risks include infection, wound breakdown, or cerebrospinal fluid leakage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 24 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

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