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NCT04243889

Fetoscopic NEOX Cord 1K® Spina Bifida Repair

Active, enrolled NA Last updated 3 September 2025
What this trial tests

NA trial testing NEOX Cord 1K in Spina Bifida in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
28 August 2020
Primary endpoint
30 May 2023
12 March 2029

Quick facts

Lead sponsorThe University of Texas Health Science Center, Houston
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment50
Start date28 August 2020
Primary completion30 May 2023
Estimated completion12 March 2029
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, any sex, with Spina Bifida or Myelomeningocele. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To fetoscopically use cryopreserved human umbilical cord allografts, named NEOX Cord 1K®, as a spinal cord cover of spina bifida defects. This procedure will be performed to create a watertight seal covering over the spinal cord in order to decrease the incidence rates of postnatal morbidities. For larger skin defects, NEOX Cord 1K® may be used as a skin cover.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Fetoscopic Myelomeningocele (MMC) Repair: Evolution of the Technique and a Call for Standardization.
    Cruz SM, Hameedi S, Sbragia L, Ogunleye O, et al · · 2025 · cited 2× · PMID 40094785 · DOI 10.3390/jcm14051402
  2. Evolution and Variations of the Ovine Model of Spina Bifida.
    Lee SY, Du Y, Hassan AS, Brown E, et al · · 2023 · cited 1× · PMID 37393899 · DOI 10.1159/000531750
  3. Morphometric analysis of spina bifida after fetal repair shows new subtypes with associated outcomes.
    Mann LK, Pandiri S, Agarwal N, Northrup H, et al · · 2025 · PMID 40848293 · DOI 10.1002/uog.70035

Verify or expand the search:

Other recruiting trials for Spina Bifida

Currently open trials in the same condition.

Other The University of Texas Health Science Center, Houston trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04243889.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing