Spina BifidaNCT04243889
Fetoscopic NEOX Cord 1K® Spina Bifida Repair
A study testing NEOX Cord 1K in people with Spina Bifida and Myelomeningocele, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spina Bifida, Myelomeningocele, Myeloschisis
- What is being tested?
- NEOX Cord 1K
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2020to 12 Mar 2029
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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.
- Conditions
- Spina Bifida, Myelomeningocele, Myeloschisis
- Being tested
- NEOX Cord 1K
- Keywords
- Neox Cord 1K, Fetoscopic repair, Cryopreserved human umbilical cord
- Medical subject headings
- Spinal Dysraphism, Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NEOX Cord 1K |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Pregnant Women 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.
Measured: Immediately after repair procedure
Secondary outcomes (2)
Number of Infants With Intact Repair of the Defect, Defined as no Cerebrospinal Fluid Leakage and no Dehiscence at the Repair Site.
Measured: Birth
Number of Infants With Intact Repair of the Defect as Defined as no Cerebrospinal Fluid Leakage and no Dehiscence at the Repair Site.
Measured: 12 months ± 2 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start28 Aug 2020
- Primary completion30 May 2023
- Study completion12 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramesha Papanna, The University of Texas Health Science Center, Houston
- Investigators
- Ramesha Papanna, MD, MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243889
- Sponsor's protocol ID
- HSC-MS-19-1051
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2020
- Last updated
- 25 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38207160
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetoscopic Spina Bifida Repair Using a Cryopreserved Human Umbilical Cord Allograft (NEOX Cord 1K®) as a Meningeal Patch
- ClinicalTrials.gov ID
- NCT04243889
- Acronym / sponsor ID
- HSC-MS-19-1051
- Conditions
- Spina Bifida, Myelomeningocele, Myeloschisis
- Keywords
- Neox Cord 1K, Fetoscopic repair, Cryopreserved human umbilical cord
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 12 Mar 2029 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Posted 25 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEOX Cord 1K applied fetoscopically | Experimental | Device: NEOX Cord 1KPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEOX Cord 1KUnder 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. | Device | NEOX Cord 1K applied fetoscopically |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38207160Backley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramesha Papanna, MD, MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEOX Cord 1K in people with Spina Bifida and Myelomeningocele, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Pregnant Women With Successful Fetoscopic Repair of the Defect Using NEOX Cord 1K® (time frame: Immediately after repair procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04243889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.