Fetoscopic NEOX Cord 1K® Spina Bifida Repair

  • STATUS
    Recruiting
  • End date
    Feb 28, 2031
  • participants needed
    50
  • sponsor
    The University of Texas Health Science Center, Houston
Updated on 1 July 2022
body mass index
myelomeningocele
spinal cord disease

Summary

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.

Details
Condition Spina Bifida, Myelomeningocele, Myeloschisis
Treatment NEOX Cord 1K applied fetoscopically
Clinical Study IdentifierNCT04243889
SponsorThe University of Texas Health Science Center, Houston
Last Modified on1 July 2022

Eligibility

Yes No Not Sure

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 CMA, or a CMA with variants of unknown significance

Exclusion Criteria

Maternal exclusion criteria
Non-resident of the United States
Poorly controlled insulin-dependent pregestational diabetes
Multifetal pregnancy
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 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
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