Fetoscopic NEOX Cord 1K® Spina Bifida Repair

Spina Bifida Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04243889
• Other study ID #: HSC-MS-19-1051
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: February 28, 2031

Study information

• Verified date: June 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Ramesha Papanna, MD, MPH
• Phone: (713) 500-6423
• Email: Ramesha.Papanna[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. For larger skin defects, NEOX Cord 1K® may be used as a skin cover.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2031
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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 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

Related Conditions & MeSH terms

• Meningomyelocele
• Myelomeningocele
• Spina Bifida
• Spinal Dysraphism

Intervention

Device:
• NEOX Cord 1K applied fetoscopically
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Number of patients with absence of syringomyelia as assessed by an MRI.		12 ± 2 months post birth
Other	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
Other	Number of patients needing de-tethering surgery before the 12 month ± 2 month visit as clinically indicated.		12 ± 2 months
Other	Developmental motor scales as assessed by the Bayley IV test.		30-36 months follow up post birth
Other	Adaptive behavior as assessed by the Vineland Adaptive Behavior Scales III		30-36 months and 60-66 months post delivery
Other	Achievement as measured by the Woodcock-Johnson IV Test of Achievement test		60-66 months post birth
Other	Assess brain stem function, as measured by the child's swallowing profile		12 ± 2 months; 30-36 months and 60-66 months post birth
Other	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
Other	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
Other	Verbal and non-verbal intelligence as measured by the Kaufman Brief Intelligence Test 2 (KBIT-2)		60-66 months post delivery
Other	Manual dexterity and bimanual coordination as determined by the Purdue Pegboard test		60-66 months post delivery
Other	Executive function testing as measured by the Behavior Rating Inventory of Executive Function 2 (BRIEF2) test		60-66 months post delivery
Other	Visual motor integration as assessed by the Beery Visual-Motor Integration test		60-66 months post delivery
Other	Quality of Life as assessed by the Parkin Spina Bifida Health-Related Quality of Life questionnaire		60-66 months post delivery
Primary	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	Number of patients with intact repair of the defect, defined as no cerebrospinal fluid leakage and no dehiscence at the repair site.		Birth
Secondary	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