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ACTIVE NOT RECRUITING

NCT04243889

Fetoscopic NEOX Cord 1K® Spina Bifida Repair

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-08-28

Completion Date

2029-03-12

Last Updated

2025-09-03

Healthy Volunteers

Conditions

Spina Bifida Myelomeningocele Myeloschisis

Interventions

DEVICE

NEOX Cord 1K

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.

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States