Fetoscopic NEOX Cord 1K® Spina Bifida Repair
Not Applicable
Active, not recruiting
- Conditions
- Spina BifidaMyelomeningoceleMyeloschisis
- Interventions
- Device: NEOX Cord 1K
- Registration Number
- NCT04243889
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NEOX Cord 1K applied fetoscopically NEOX Cord 1K Patients intending to undergo open in-utero spina bifida repair, will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled.
- Primary Outcome Measures
Name Time Method Number of patients with successful fetoscopic repair of the defect using NEOX Cord 1K® 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 Outcome Measures
Name Time Method Number of patients with intact repair of the defect, defined as no cerebrospinal fluid leakage and no dehiscence at the repair site. Birth Number of patients with intact repair of the defect as defined as no cerebrospinal fluid leakage and no dehiscence at the repair site. 12 months ± 2 months
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States