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

Primary Purpose

Spina Bifida; Fetus, Myelomeningocele, Myeloschisis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NEOX Cord 1K applied fetoscopically
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spina Bifida; Fetus focused on measuring Fetoscopic fetal intervention, Human umbilical cord, NEOX Cord 1K

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 ≤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 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 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: 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 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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NEOX Cord 1K applied fetoscopically

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2023
Last Updated
September 11, 2023
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT06042140
Brief Title
Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair
Acronym
HUC-FICS
Official Title
Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair: Single Arm Phase III Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
March 8, 2031 (Anticipated)
Study Completion Date
September 8, 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spina Bifida; Fetus, Myelomeningocele, Myeloschisis
Keywords
Fetoscopic fetal intervention, Human umbilical cord, NEOX Cord 1K

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NEOX Cord 1K applied fetoscopically
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NEOX Cord 1K applied fetoscopically
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants that can ambulate independently by walking at least 10 steps
Time Frame
30-36 months after delivery
Secondary Outcome Measure Information:
Title
Number of participants with lower extremity motor and sensory levels exceeding the anatomical level of the lesion by ≥ 2 segments
Time Frame
30-36 months after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ≤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 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 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: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramesha Papanna, MD, MPH
Phone
(713) 500-6423
Email
Ramesha.Papanna@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeannine Garnett, PhD
Phone
(713) 486-6557
Email
Jeannine.Garnett@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramesha Papanna, MD, MPH
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramesha Papanna, MD, MPH
Phone
713-500-6423
Email
Ramesha.Papanna@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Jeannine Garnett, PhD
Phone
(713) 486-6557
Email
Jeannine.Garnett@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Ramesha Papanna, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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

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