Fetoscopic NEOX Cord 1K® Spina Bifida Repair

July 31, 2026 updated by: Ramesha Papanna, The University of Texas Health Science Center, Houston

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NEOX Cord 1K applied fetoscopically
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Pregnant Women With Successful Fetoscopic Repair of the Defect Using NEOX Cord 1K®
Time Frame: 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.
Immediately after repair procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Infants With Intact Repair of the Defect, Defined as no Cerebrospinal Fluid Leakage and no Dehiscence at the Repair Site.
Time Frame: Birth
Birth
Number of Infants 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 after birth
12 months ± 2 months after birth

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of Arnold-Chiari Malformation II
Time Frame: birth discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth
Assessment of Arnold-Chiari malformation II as measured by MRI of head
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.
Time Frame: birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth
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.
Time Frame: 2 ± 2 months, 30-36 months and 60-66 months post birth
2 ± 2 months, 30-36 months and 60-66 months post birth
Number of Patients Who Can Ambulate With or Without the Use of Orthotics or Devices.
Time Frame: 12 ± 2 months, 30-36 months and 60-66 months post birth
12 ± 2 months, 30-36 months and 60-66 months post birth
Number of Patients With no Spinal Cord Tethering as Assessed by a Lumbar Spine MRI.
Time Frame: birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth
birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth
Number of Patients With Absence of Syringomyelia as Assessed by an MRI.
Time Frame: 12 ± 2 months post birth
12 ± 2 months post birth
Number of Patient With the Absence of an Epidermoid Cyst at the Repair Site, Determined by MRI.
Time Frame: birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth
birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth
Number of Patients Needing De-tethering Surgery Before the 12 Month ± 2 Month Visit as Clinically Indicated.
Time Frame: 12 ± 2 months
12 ± 2 months
Developmental Motor Scales as Assessed by the Bayley IV Test.
Time Frame: 30-36 months follow up post birth
30-36 months follow up post birth
Adaptive Behavior as Assessed by the Vineland Adaptive Behavior Scales III
Time Frame: 30-36 months and 60-66 months post delivery
30-36 months and 60-66 months post delivery
Achievement as Measured by the Woodcock-Johnson IV Test of Achievement Test
Time Frame: 60-66 months post birth
60-66 months post birth
Assess Brain Stem Function, as Measured by the Child's Swallowing Profile
Time Frame: 12 ± 2 months; 30-36 months and 60-66 months post birth
12 ± 2 months; 30-36 months and 60-66 months post birth
Urodynamic Function Assessments
Time Frame: 12 ± 2 months, 30-36 months and 60-66 months post birth
Objective measures of the function of the lower urinary tract by evaluating post-void residual urine
12 ± 2 months, 30-36 months and 60-66 months post birth
Bowel Function Assessments Bowel Movements.
Time Frame: 12 ± 2 months, 30-36 months and 60-66 months post birth
Bowel function as assessed by observation of neurogenic bowel incontinence or constipation
12 ± 2 months, 30-36 months and 60-66 months post birth
Verbal and Non-verbal Intelligence as Measured by the Kaufman Brief Intelligence Test 2 (KBIT-2)
Time Frame: 60-66 months post delivery
60-66 months post delivery
Manual Dexterity and Bimanual Coordination as Determined by the Purdue Pegboard Test
Time Frame: 60-66 months post delivery
60-66 months post delivery
Executive Function Testing as Measured by the Behavior Rating Inventory of Executive Function 2 (BRIEF2) Test
Time Frame: 60-66 months post delivery
60-66 months post delivery
Visual Motor Integration as Assessed by the Beery Visual-Motor Integration Test
Time Frame: 60-66 months post delivery
60-66 months post delivery
Quality of Life as Assessed by the Parkin Spina Bifida Health-Related Quality of Life Questionnaire
Time Frame: 60-66 months post delivery
60-66 months post delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ramesha Papanna, MD, MPH, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-19-1051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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