Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair

NCT06042140 | Recruiting DMC FDA Device

• 2 other identifiers: HSC-MS-23-05841R01HD119340-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch.

Conditions

Spina Bifida; Fetus; Myelomeningocele; Myeloschisis

Keywords

Fetoscopic fetal intervention; Human umbilical cord; NEOX Cord 1K

Outcome Measures

Primary Outcomes (1)

• Number of participants that can ambulate independently by walking at least 10 steps

  30-36 months after delivery

Secondary Outcomes (1)

• Number of participants with lower extremity motor and sensory levels exceeding the anatomical level of the lesion by ≥ 2 segments

  30-36 months after delivery

Study Arms (1)

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 Pediatric 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 applied fetoscopically

Interventions

NEOX Cord 1K applied fetoscopically 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® (human umbilical cord) will be used for skin closure at the discretion of the Pediatric Neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.

NEOX Cord 1K applied fetoscopically

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤45 kg/m2 (pre-pregnancy)
• No preterm birth risk factors (short cervix \<20 mm or a 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
• 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 a normal chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance \[fluorescence in situ hybridization (FISH) acceptable if ≥ 24 weeks\].

You may not qualify if:

• 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 \> 45 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Spinal Dysraphism; Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ramesha Papanna, MD, MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramesha Papanna, MD, MPH

CONTACT

(713) 500-6423; Ramesha.Papanna@uth.tmc.edu

Stephanie W Conaway, BSN

CONTACT

(713) 486-6558; Stephanie.L.Whitney@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: September 8, 2023
• Primary Completion (Estimated): March 8, 2031
• Study Completion (Estimated): September 8, 2036
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)