Fetoscopic NEOX Cord 1K® Spina Bifida Repair

NCT04243889 | Active Not Recruiting DMC FDA Device

• 1 other identifier: HSC-MS-19-1051
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Spina Bifida; Myelomeningocele; Myeloschisis

Keywords

Neox Cord 1K; Fetoscopic repair; Cryopreserved human umbilical cord

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after repair procedure

Secondary Outcomes (2)

• 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

Other Outcomes (19)

• Assessment of Arnold-Chiari malformation II

  birth discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth

• Number of patients with absence of brain stem kinking as assessed by MRI evaluation.

  birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth

• Number of patients with lower extremity motor and sensory levels exceeding the anatomical level of the lesion by ≥ 2 segments.

  2 ± 2 months, 30-36 months and 60-66 months post birth

Study Arms (1)

NEOX Cord 1K applied fetoscopically

EXPERIMENTAL

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.

Device: NEOX Cord 1K

Interventions

NEOX Cord 1K DEVICE

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.

NEOX Cord 1K applied fetoscopically

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Backley S, Bergh EP, Garnett J, Li R, Maroufy V, Jain R, Fletcher S, Tsao K, Austin M, Johnson A, Papanna R. Fetal cardiovascular changes during open and fetoscopic in-utero spina bifida closure. Ultrasound Obstet Gynecol. 2024 Aug;64(2):193-202. doi: 10.1002/uog.27579.

  PMID: 38207160 DERIVED

MeSH Terms

Conditions

Spinal Dysraphism; Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ramesha Papanna, MD, MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 28, 2020
• Study Start: August 28, 2020
• Primary Completion: May 30, 2023
• Study Completion (Estimated): March 12, 2029
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)