Actively Recruiting
Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair: Single Arm Phase III Trial.
Led by The University of Texas Health Science Center, Houston · Updated on 2025-08-13
100
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a laparotomy-assisted fetoscopic surgical method to repair spina bifida defects in fetuses by using cryopreserved human umbilical cords (NEOX Cord 1K ae) as a patch over the spinal cord and sometimes skin. This single-arm phase III trial aims to test how well this technique works for closing developmental spinal cord defects during pregnancy in female patients. The procedure begins with general anesthesia and tocolysis, followed by a laparotomy to expose the uterus. The fetus is positioned externally, and three cannulas are inserted for uterine access with heated-humidified carbon dioxide to aid visualization. The surgeon then fetoscopically examines and repairs the spinal lesion using NEOX Cord 1K ae as a meningeal patch, with skin closure done either primarily or with the umbilical cord product if needed. After repair, the uterus is sutured in layers. All fetuses enrolled receive this treatment as part of the trial. Participants will be evaluated mainly by their ability to walk independently 30 to 36 months after delivery. Additional assessments include measuring motor and sensory function improvements below the lesion. The study involves follow-up visits to monitor neurological development and motor skills over several years. Mothers and babies will be closely monitored to assess the surgical repair and its outcomes.
CONDITIONS
Brief Title
Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 18 years or older
- Singleton pregnancy
- Gestational age at screening between 19 and 25 5/7 weeks
- Gestational age at surgery between 22 and 25 6/7 weeks
- Pre-pregnancy body mass index of 45 kg/m2 or less
- No risk factors for preterm birth such as short cervix under 20 mm or previous preterm delivery
- No previous uterine incision in the active uterine segment
- Willingness to undergo open fetal repair if fetoscopic approach is unsuccessful
- Fetus diagnosed with spina bifida defect between T1 to S1 vertebral levels
- Presence of Chiari II malformation
- No evidence of kyphosis (curved spine)
- No major life-threatening fetal anomalies unrelated to spina bifida
- Normal karyotype or normal chromosomal microarray analysis (CMA) or CMA with variants of unknown significance
- Fluorescence in situ hybridization (FISH) acceptable if at least 24 weeks gestation
You will not qualify if you...
- Non-resident of the United States
- Multifetal pregnancy
- Poorly controlled insulin-dependent pregestational diabetes
- Poorly controlled insulin-dependent A2 diabetes mellitus
- Current or planned cervical cerclage or history of incompetent cervix
- Placenta previa or placental abruption
- Short cervix less than 20 mm
- Obesity with body mass index over 45 kg/m2
- Previous spontaneous singleton delivery before 37 weeks
- Maternal-fetal Rh isoimmunization, Kell sensitization, or history of neonatal alloimmune thrombocytopenia
- Positive HIV or Hepatitis B status
- Known Hepatitis C positivity
- Uterine anomalies such as large or multiple fibroids or mullerian duct abnormalities that cannot be avoided during surgery
- Medical conditions contraindicating surgery or general anesthesia
- Lack of a support person
- Inability to comply with travel and follow-up requirements
- Failure to meet psychosocial assessment criteria
- Participation in other intervention studies affecting maternal or fetal health
- Maternal hypertension
- Zika virus positivity
- Allergy or history of reaction to Amphotericin B
- Fetal major anomalies unrelated to spina bifida
- Fetal kyphosis of 30 degrees or more
- Ventriculomegaly greater than 15 mm with no fetal hip and knee movements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with hospital stay as per routine care
Participants undergo a fetoscopic spina bifida repair procedure where NEOX Cord 1K® is applied as a meningeal patch to cover the spinal defect, with possible skin coverage as needed.
1 surgical visit (in-person)
Duration - Up to 36 months after delivery
Participants are monitored after the fetoscopic repair to assess recovery and outcomes related to the intervention.
Multiple follow-up visits over 30 to 36 months
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Ramesha Papanna, MD, MPH
S
Stephanie W Conaway, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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