Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair (HUC-FICS)

Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair: Single Arm Phase III Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Myelomeningocele; Myeloschisis; Spina Bifida; Fetus
• Intervention / Treatment: Device: NEOX Cord 1K applied fetoscopically

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramesha Papanna, MD, MPH; Phone Number: (713) 500-6423; Email: Ramesha.Papanna@uth.tmc.edu
• Study Contact Backup: Name: Stephanie W Conaway, BSN; Phone Number: (713) 486-6558; Email: Stephanie.L.Whitney@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Ramesha Papanna, MD, MPH; Phone Number: 713-500-6423; Email: Ramesha.Papanna@uth.tmc.edu
      • Principal Investigator: Ramesha Papanna, MD, MPH
      • Contact: Stephanie W Conaway, BSN; Phone Number: (713) 486-6558; Email: Stephanie.L.Whitney@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Maternal Inclusion Criteria:

1. Singleton pregnancy
2. Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks
3. Maternal age: 18 years and older
4. Body mass index ≤45 kg/m2 (pre-pregnancy)
5. No preterm birth risk factors (short cervix <20 mm or a history of previous preterm delivery)
6. No previous uterine incision in the active uterine segment
7. Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful

Fetal Inclusion Criteria:

1. Spina bifida defect between T1 to S1 vertebral levels
2. Chiari II malformation
3. No evidence of kyphosis (curved spine)
4. No major life-threatening fetal anomaly unrelated to spina bifida
5. 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].

Exclusion Criteria:

Maternal Exclusion Criteria:

1. Non-resident of the United States
2. Multifetal pregnancy
3. Poorly controlled insulin-dependent pregestational diabetes
4. Poorly controlled A2 diabetes mellitus (A2DM) insulin-dependent diabetes
5. Current or planned cerclage or documented history of an incompetent cervix
6. Placenta previa or placental abruption
7. Short cervix of < 20 mm
8. Obesity as defined by a body mass index of > 45 kg/m2
9. Previous spontaneous singleton delivery prior to 37 weeks
10. Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal alloimmune thrombocytopenia
11. HIV or Hepatitis-B positive status
12. Known Hepatitis-C positivity
13. 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
14. Other medical conditions which are contraindication to surgery or general anesthesia
15. Patient does not have a support person
16. Inability to comply with the travel and follow-up requirements of the trial
17. Patient does not meet psychosocial standardized assessment criteria
18. Participation in this or another intervention study that influences maternal and fetal morbidity and mortality
19. Maternal hypertension
20. Zika virus positivity
21. Allergy/history of drug reaction to Amphotericin B

Fetal exclusion criteria:

1. Major fetal anomaly not related to spina bifida
2. Kyphosis in the fetus of 30 degrees or more
3. Ventriculomegaly greater than 15 mm and no movements noted at hip and knee joints

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NEOX Cord 1K applied fetoscopically; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants that can ambulate independently by walking at least 10 steps	30-36 months after delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Ramesha Papanna, MD, MPH, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Estimated): March 8, 2031
• Study Completion (Estimated): September 8, 2036

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Fetoscopic fetal intervention; Human umbilical cord; NEOX Cord 1K
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism; Meningomyelocele; Spina Bifida Cystica
• Other Study ID Numbers: HSC-MS-23-0584; 1R01HD119340-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes