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NCT Number: NCT04243889

Fetoscopic NEOX Cord 1K® Spina Bifida Repair

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Spina Bifida Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Meningomyelocele Myelomeningocele Myeloschisis Nervous System Diseases Nervous System Malformations Neural Tube Defects Spinal Dysraphism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Uterine anomaly such as large or multiple fibroids or a mullerian duct abnormality that is diagnosed via imaging prior to surgery, which that are unavoidable during surgery
  • Other medical conditions which are contraindication to surgery or general anesthesia
  • Patient does not have a support person
  • Inability to comply with the travel and follow-up requirements of the trial
  • Patient does not meet psychosocial standardized assessment criteria
  • Participation in this or another intervention study that influences maternal and fetal morbidity and mortality
  • Maternal hypertension
  • Zika virus positivity
  • Allergy/history of drug reaction to Amphotericin B

Fetal exclusion criteria:

  • Major fetal anomaly not related to spina bifida
  • Kyphosis in the fetus of 30 degrees or more
  • Ventriculomegaly greater than 15 mm and no movements noted at hip and knee joints

Treatment and study plan

NEOX Cord 1K

Device

Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (HUC) will be used for skin closure at the discretion of the neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.

Primary outcomes

  1. Number of patients with successful fetoscopic repair of the defect using NEOX Cord 1K®

    Time frame: Immediately after repair procedure

    A digital image of the fetal repair site will be captured during and immediately after the repair. The images will be sent to three independent blinded neurosurgeons for review of successful closure of the defect. More than best of three votes will be considered as the result.

Secondary outcomes

  1. Number of patients with intact repair of the defect, defined as no cerebrospinal fluid leakage and no dehiscence at the repair site.

    Time frame: Birth

  2. Number of patients with intact repair of the defect as defined as no cerebrospinal fluid leakage and no dehiscence at the repair site.

    Time frame: 12 months ± 2 months

Other outcomes

  1. Assessment of Arnold-Chiari malformation II

    Time frame: birth discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth

    Assessment of Arnold-Chiari malformation II as measured by MRI of head

  2. Number of patients with absence of brain stem kinking as assessed by MRI evaluation.

    Time frame: birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth

  3. Number of patients with lower extremity motor and sensory levels exceeding the anatomical level of the lesion by ≥ 2 segments.

    Time frame: 2 ± 2 months, 30-36 months and 60-66 months post birth

  4. Number of patients who can ambulate with or without the use of orthotics or devices.

    Time frame: 12 ± 2 months, 30-36 months and 60-66 months post birth

  5. Number of patients with no spinal cord tethering as assessed by a lumbar spine MRI.

    Time frame: birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth

  6. Number of patients with absence of syringomyelia as assessed by an MRI.

    Time frame: 12 ± 2 months post birth

  7. Number of patient with the absence of an epidermoid cyst at the repair site, determined by MRI.

    Time frame: birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth

  8. Number of patients needing de-tethering surgery before the 12 month ± 2 month visit as clinically indicated.

    Time frame: 12 ± 2 months

  9. Developmental motor scales as assessed by the Bayley IV test.

    Time frame: 30-36 months follow up post birth

  10. Adaptive behavior as assessed by the Vineland Adaptive Behavior Scales III

    Time frame: 30-36 months and 60-66 months post delivery

  11. Achievement as measured by the Woodcock-Johnson IV Test of Achievement test

    Time frame: 60-66 months post birth

  12. Assess brain stem function, as measured by the child's swallowing profile

    Time frame: 12 ± 2 months; 30-36 months and 60-66 months post birth

  13. Urodynamic function assessments

    Time frame: 12 ± 2 months, 30-36 months and 60-66 months post birth

    Objective measures of the function of the lower urinary tract by evaluating post-void residual urine

  14. Bowel function assessments bowel movements.

    Time frame: 12 ± 2 months, 30-36 months and 60-66 months post birth

    Bowel function as assessed by observation of neurogenic bowel incontinence or constipation

  15. Verbal and non-verbal intelligence as measured by the Kaufman Brief Intelligence Test 2 (KBIT-2)

    Time frame: 60-66 months post delivery

  16. Manual dexterity and bimanual coordination as determined by the Purdue Pegboard test

    Time frame: 60-66 months post delivery

  17. Executive function testing as measured by the Behavior Rating Inventory of Executive Function 2 (BRIEF2) test

    Time frame: 60-66 months post delivery

  18. Visual motor integration as assessed by the Beery Visual-Motor Integration test

    Time frame: 60-66 months post delivery

  19. Quality of Life as assessed by the Parkin Spina Bifida Health-Related Quality of Life questionnaire

    Time frame: 60-66 months post delivery

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Fetoscopic Spina Bifida Repair Using a Cryopreserved Human Umbilical Cord Allograft (NEOX Cord 1K®) as a Meningeal Patch

Important dates

Study start
2020
Primary completion
2023
Study completion
2029
First posted
Jan 28, 2020
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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