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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Maternal inclusion criteria:
* Singleton pregnancy
* Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks
* Maternal age: 18 years and older
* Body mass index \< 40 kg/m2
* No preterm birth risk factors (short cervix, history of previous preterm delivery)
* No previous uterine incision in the active uterine segment
* Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful
Fetal inclusion criteria:
* Spina bifida defect between T1 to S1 vertebral levels
* Chiari II malformation
* No evidence of kyphosis (curved spine)
* No major life-threatening fetal anomaly unrelated to spina bifida
* Normal karyotype, or normal Chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance
Exclusion Criteria:
Maternal exclusion criteria:
* Non-resident of the United States
* Multifetal pregnancy
* Poorly controlled insulin-dependent pregestational diabetes
* Poorly controlled A2 diabetes mellitus (A2DM) insulin-dependent diabetes
* Current or planned cerclage or documented history of an incompetent cervix
* Placenta previa or placental abruption
* Short cervix of \< 20 mm
* Obesity as defined by a body mass index of \> 40 kg/m2
* Previous spontaneous singleton delivery prior to 37 weeks
* Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal alloimmune thrombocytopenia
* HIV or Hepatitis-B positive status
* Known Hepatitis-C positivity
* U…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with successful fetoscopic repair of the defect using NEOX Cord 1K®
Timeframe: Immediately after repair procedure
Trial details
NCT IDNCT04243889
SponsorThe University of Texas Health Science Center, Houston