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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Arnold-Chiari malformation II | 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. |
Inclusion Criteria:
Maternal inclusion criteria:
Fetal inclusion criteria:
Exclusion Criteria:
Maternal exclusion criteria:
Fetal exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramesha Papanna, MD, MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38207160 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 22, 2026 | Jun 17, 2026 | 6 |
| ID | Term |
|---|---|
| D016135 | Spinal Dysraphism |
| D008591 | Meningomyelocele |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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|
| 12 months ± 2 months |
| 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 |
| Number of patients who can ambulate with or without the use of orthotics or devices. | 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. | 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. | 12 ± 2 months post birth |
| Number of patient with the absence of an epidermoid cyst at the repair site, determined by MRI. | 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. | 12 ± 2 months |
| Developmental motor scales as assessed by the Bayley IV test. | 30-36 months follow up post birth |
| Adaptive behavior as assessed by the Vineland Adaptive Behavior Scales III | 30-36 months and 60-66 months post delivery |
| Achievement as measured by the Woodcock-Johnson IV Test of Achievement test | 60-66 months post birth |
| Assess brain stem function, as measured by the child's swallowing profile | 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 | 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 | 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) | 60-66 months post delivery |
| Manual dexterity and bimanual coordination as determined by the Purdue Pegboard test | 60-66 months post delivery |
| Executive function testing as measured by the Behavior Rating Inventory of Executive Function 2 (BRIEF2) test | 60-66 months post delivery |
| Visual motor integration as assessed by the Beery Visual-Motor Integration test | 60-66 months post delivery |
| Quality of Life as assessed by the Parkin Spina Bifida Health-Related Quality of Life questionnaire | 60-66 months post delivery |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |