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Early Feasibility Study: Fetoscopic NEOX Cord 1K® Myelomeningocele (MMC) Repair

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ClinicalTrials.gov Identifier: NCT04243889
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Ramesha Papanna, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to test the feasibility of surgically covering myelomeningocele spina bifida spinal cord developmental defects using Neox Cord 1K, cryopreserved human umbilical cords, via a laparotomy-fetoscopic surgical approach. Intact repair of the defect, prevention of cerebral spinal fluid leakage and wound dehiscence will be assessed at birth and at 12 months of age.

Condition or disease Intervention/treatment Phase
Spina Bifida Fetus Risk Myelomeningocele Device: NEOX Cord 1K applied fetoscopically Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of Fetoscopic Myelomeningocele Repair Using a Cryopreserved Human Umbilical Cord Allograft (NEOX Cord 1K®) as a Meningeal Patch
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : August 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NEOX Cord 1K applied fetoscopically Device: NEOX Cord 1K applied fetoscopically
Under general anesthesia and tocolysis, in-utero repair starts with a laparotomy, followed by exteriorization of the uterus and external cephalic version to position the fetus. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Fetoscopically, the placode will be dissected and the lesion repaired. NEOX Cord 1K®, a cryopreserved human umbilical cord patch, will be used for meningeal closure over the spinal cord, followed by closure of the fetal skin layer. Next, the carbon dioxide will be removed and replaced with amniotic fluid or with Lactated Ringers Solution. Finally, the fetoscopic hysterotomy sites will be sutured, and the laparotomy site closed in multiple layers.




Primary Outcome Measures :
  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 immediately after the repair. The images will be sent to three independent blinded neurosurgeons for review for the successful closure of the defect. More than best of three votes will be considered as the result.


Secondary Outcome Measures :
  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 ]

Other Outcome Measures:
  1. Urodynamic function assessments [ Time Frame: 1 month,12 months,30 months and 60 months post birth ]
    Objective measures of the function of the lower urinary tract by evaluating post-void residual urine

  2. Bowel function assessments bowel movements. [ Time Frame: 1 month,12 months,30 months and 60 months post birth ]
    Bowel function as assessed by observation of neurogenic bowel incontinence or constipation

  3. Number of patients who can ambulate with or without the use of orthotics or devices. [ Time Frame: 12 months, 30 months and 60 months post birth ]
  4. Assessment of Arnold-Chiari malformation II [ Time Frame: Day 1-3 after birth, 1 month, 12 months, 30 months, 60 months from birth ]
    Assessment of Arnold-Chiari malformation II as measured by MRI of head

  5. Assessment of Arnold-Chiari malformation II [ Time Frame: Day 1-3 after birth, 1 month, 12 months, 30 months, 60 months from birth ]
    Assessment of Arnold-Chiari malformation II as measured by head ultrasound of head

  6. Number of patients with no spinal cord tethering as assessed by a lumbar spine MRI. [ Time Frame: 12 months, 30 months, 60 months from birth ]
  7. Number of patient with the absence of an epidermoid cyst at the repair site, determined by physical and radiologic examination. [ Time Frame: 12 months and 60 months post delivery ]
  8. Number of patients with absence of brain stem kinking as assessed by MRI evaluation. [ Time Frame: 12 months, 30 months, 60 months post delivery ]
  9. Number of patients with a need for ventricular diversion surgery before the 12 month visit. [ Time Frame: 12 months ]
  10. Number of patients needing de-tethering surgery before the 12 month visit as assessed by an MRI. [ Time Frame: 12 months, 30 months, 60 months post birth ]
  11. Number of patients with absence of syringomyelia as assessed by an MRI. [ Time Frame: 12 months, 30 months, 60 months post birth ]
  12. Number of patients with spinal cord tethering as assessed by MRI evaluation [ Time Frame: 30 months and 60 months post birth ]
  13. Infant Psychomotor development as assessed by the Bayley Scales of Infant Development II (BSID-II) [ Time Frame: 12 months and 30 months follow up post birth ]
  14. Toddler temperament as assessed by the Carey Toddler Temperament Questionnaire [ Time Frame: 12 months and 30 months follow up post birth ]
  15. Developmental Motor Scales as assessed by the Peabody test [ Time Frame: 12 months and 30 months follow up post birth ]
  16. Adaptive behavior as assessed by the Vineland Adaptive Behavior Scales II [ Time Frame: 30 months and 60 months post delivery ]
  17. Assess the degree of disability, as measured by the WeeFIM (Functional Independence Measure for Children) instrument [ Time Frame: 30 months post birth ]
  18. Achievement as measured by the Woodcock-Johnson III Test of Achievement test [ Time Frame: 30 months and 60 months post birth ]
  19. Memory as assessed by the Children's Memory Scale test [ Time Frame: 60 months post birth ]
  20. Assess brain stem function, as measured by the child's swallowing profile [ Time Frame: 30 months and 60 months post birth ]
  21. Number of patients with lower extremity motor and sensory levels exceeding the anatomical level of the lesion by ≥ 2 segments. [ Time Frame: 12 months and 60 months post birth ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Maternal inclusion criteria:

  • Singleton pregnancy
  • Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 23 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
  • Myelomeningocele spina bifida ≤ 4 cm in width of the sac
  • Hindbrain herniation (HH)
  • No evidence of kyphosis (curved spine)
  • No major life-threatening fetal anomaly unrelated to spina bifida
  • Normal karyotype

Exclusion Criteria:

Maternal exclusion criteria:

  • Non-resident of the United States
  • Multifetal pregnancy
  • Insulin-dependent pregestational diabetes
  • Poorly controlled 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243889


Contacts
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Contact: Ramesha Papanna, MD, MPH (713) 500-6423 Ramesha.Papanna@uth.tmc.edu
Contact: Jeannine Garnett, PhD (713) 486-6557 Jeannine.Garnett@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Ramesha Papanna, MD, MPH    713-500-6423    Ramesha.Papanna@uth.tmc.edu   
Contact: Jeannine Garnett, PhD    (713) 486-6557    Jeannine.Garnett@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Ramesha Papanna, MD, MPH The University of Texas Health Science Center, Houston
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Responsible Party: Ramesha Papanna, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04243889    
Other Study ID Numbers: HSC-MS-19-1051
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Ramesha Papanna, The University of Texas Health Science Center, Houston:
Neox Cord 1K
Fetoscopic repair
Cryopreserved human umbilical cord
Additional relevant MeSH terms:
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Spinal Dysraphism
Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities