Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for pregnant women over 18 with a single pregnancy, carrying fetuses with spina bifida but no other major unrelated anomalies or kyphosis. The fetus must have a normal karyotype and the defect between T1 to S1 vertebral levels. Women must be within a specific gestational age range, have no significant health risks or previous preterm deliveries, and BMI under 40 kg/m2.Inclusion Criteria
You do not have any factors that could increase the risk of having a baby born too early.
I am 18 years old or older.
The baby does not have a curved spine.
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Exclusion Criteria
I am HIV or Hepatitis-B positive.
The placenta is in the wrong place or there is bleeding behind the placenta during pregnancy.
If you are pregnant, your cervix is shorter than 20 millimeters.
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Participant Groups
The trial tests the use of NEOX Cord 1K®, cryopreserved human umbilical cord allografts, applied via fetoscopy as a cover for spina bifida defects in fetuses. It aims to create a watertight seal on the spinal cord to reduce postnatal complications and may also serve as skin cover for larger defects.
1Treatment groups
Experimental Treatment
Group I: NEOX Cord 1K applied fetoscopicallyExperimental Treatment1 Intervention
Patients intending to undergo open in-utero spina bifida repair, will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor