Fetoscopic NEOX Cord 1K® Spina Bifida Repair

N/AActive Not RecruitingNCT04243889

The University of Texas Health Science Center, Houston50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spina Bifida Myelomeningocele Myeloschisis

Interventions

NEOX Cord 1KDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

Time frame: Immediately after repair procedure

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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