An interventional study of NEOX Cord 1K in Spina Bifida, Myelomeningocele and Myeloschisis, sponsored by The University of Texas Health Science Center, Houston. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's enrollment of 100 is above the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Maternal inclusion criteria:
Fetal inclusion criteria:
Exclusion Criteria:
Maternal exclusion criteria:
Fetal exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Immediately after repair procedure
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
Assessment of Arnold-Chiari Malformation II
Assessment of Arnold-Chiari malformation II as measured by MRI of head
Time frame: 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
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
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
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
Number of Patients With Absence of Syringomyelia as Assessed by an MRI.
Time frame: 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
Number of Patients Needing De-tethering Surgery Before the 12 Month ± 2 Month Visit as Clinically Indicated.
Time frame: 12 ± 2 months
Developmental Motor Scales as Assessed by the Bayley IV Test.
Time frame: 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
Achievement as Measured by the Woodcock-Johnson IV Test of Achievement Test
Time frame: 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
Urodynamic Function Assessments
Objective measures of the function of the lower urinary tract by evaluating post-void residual urine
Time frame: 12 ± 2 months, 30-36 months and 60-66 months post birth
Bowel Function Assessments Bowel Movements.
Bowel function as assessed by observation of neurogenic bowel incontinence or constipation
Time frame: 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
Manual Dexterity and Bimanual Coordination as Determined by the Purdue Pegboard Test
Time frame: 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
Visual Motor Integration as Assessed by the Beery Visual-Motor Integration Test
Time frame: 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
| Milestone | NEOX Cord 1K Applied Fetoscopically - Pregnant Women | NEOX Cord 1K Applied Fetoscopically - Fetuses |
|---|---|---|
| Started | 50 | 50 |
| Received intervention | 49 | 49 |
| Completed | 49 | 49 |
| Not completed | 1 | 1 |
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.
| Participants | NEOX Cord 1K Applied Fetoscopically |
|---|---|
| Number of Pregnant Women With Successful Fetoscopic Repair of the Defect Using NEOX Cord 1K® | 49 |
| Participants | NEOX Cord 1K Applied Fetoscopically |
|---|---|
| Number of Infants With Intact Repair of the Defect, Defined as no Cerebrospinal Fluid Leakage and no Dehiscence at the Repair Site. | 44 |
| Participants | NEOX Cord 1K Applied Fetoscopically |
|---|---|
| Number of Infants With Intact Repair of the Defect as Defined as no Cerebrospinal Fluid Leakage and no Dehiscence at the Repair Site. | 49 |
Assessment of Arnold-Chiari malformation II as measured by MRI of head
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Objective measures of the function of the lower urinary tract by evaluating post-void residual urine
Results for this outcome have not been posted.
Bowel function as assessed by observation of neurogenic bowel incontinence or constipation
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 66 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NEOX Cord 1K Applied Fetoscopically - Pregnant Women | 0/50 (0%) | 32/50 (64%) | 0/50 (0%) |
| NEOX Cord 1K Applied Fetoscopically - Children | 0/50 (0%) | 25/50 (50%) | 0/50 (0%) |
| Event | NEOX Cord 1K Applied Fetoscopically - Pregnant Women | NEOX Cord 1K Applied Fetoscopically - Children |
|---|---|---|
| ETV or PV shunt placedNervous system disorders | 0/50 | 20/50 |
| Preterm premature rupture of membranes (PPROM)Pregnancy, puerperium and perinatal conditions | 19/50 | 0/50 |
| Spontaneous preterm laborPregnancy, puerperium and perinatal conditions | 15/50 | 0/50 |
| Neonatal wound dehiscense at birthInfections and infestations | 0/50 | 6/50 |
| Shunt revisionNervous system disorders | 0/50 | 5/50 |
| Placental abruption at deliveryPregnancy, puerperium and perinatal conditions | 4/50 | 0/50 |
| Patient required oxygen post-fetal repairRespiratory, thoracic and mediastinal disorders | 3/50 | 0/50 |
| SeizureNervous system disorders | 0/50 | 3/50 |
| fetus developed transient bradycardia during procedureCardiac disorders | 0/50 | 3/50 |
| Maternal wound infectionInfections and infestations | 2/50 | 0/50 |
Baseline Characteristics were only collected from the pregnant women participants.
| Age, Continuous(years) | NEOX Cord 1K Applied Fetoscopically |
|---|---|
| Median | 29 (19 to 44) |
| Sex: Female, Male(Participants) | NEOX Cord 1K Applied Fetoscopically |
|---|---|
| Female | 50 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | NEOX Cord 1K Applied Fetoscopically |
|---|---|
| Hispanic or Latino | 14 |
| Not Hispanic or Latino | 36 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | NEOX Cord 1K Applied Fetoscopically |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 35 |
| More than one race | 0 |
| Unknown or Not Reported | 12 |
| Region of Enrollment(participants) | NEOX Cord 1K Applied Fetoscopically |
|---|---|
| United States | 50 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2020 to primary completion in May 2023, 33 months.
Results were first posted in Aug 2026, 3 years 2 months after primary completion. A results delay was requested in May 2024.
Of 60 non-industry interventional studies with no phase under Spinal Dysraphism, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's 33 months is close to that.
Counting every sponsor, half of 62 studies reached it within 31 months; a quarter within 20 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston →