Spina BifidaNCT06929572
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
A study testing Autologous umbilical cord patch in people with Spina Bifida, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Autologous umbilical cord patch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to Jan 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Stephen Fletcher, DO, 713-500-7308, Stephen.Fletcher@uth.tmc.edu
Caroline Doughty, 713-500-7481, Caroline.Doughty@uth.tmc.edu
About this study
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.
- Conditions
- Spina Bifida
- Being tested
- Autologous umbilical cord patch
- Keywords
- open neural tube defects, autologous umbilical cord patch, myelomeningocele, myeloschisis
- Medical subject headings
- Spinal Dysraphism, Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous umbilical cord patchProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Autologous umbilical cord patch | Experimental | Not described Receives: Procedure: Autologous umbilical cord patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that have wound dehiscence
Measured: one-month post-op
Number of participants that have wound dehiscence
Measured: 1-year post-op
Number of participants that have Cerebrospinal fluid (CSF) leakage
Measured: one-month post-op
Number of participants that have CSF leakage
Measured: 1-year post-op.
Secondary outcomes (2)
Number of participants that present with tethered cord syndrome
Measured: 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)
Measured: baseline, one-month post-op,12-months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start5 Aug 2025
- Primary completionJul 2028 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Fletcher, The University of Texas Health Science Center, Houston
- Investigators
- Stephen Fletcher, DO, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929572
- Sponsor's protocol ID
- HSC-MS-24-1194
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No