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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06042140
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 156
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spina Bifida; Fetus; Myelomeningocele; Myeloschisis	Device: NEOX Cord 1K applied fetoscopically	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair: Single Arm Phase III Trial.
• Actual Study Start Date: Sep 8, 2023
• Anticipated Primary Completion Date: Mar 8, 2031
• Anticipated Study Completion Date: Sep 8, 2036

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of participants that can ambulate independently by walking at least 10 steps [30-36 months after delivery]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Ramesha Papanna, MD, MPH, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ramesha Papanna, Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT06042140
• Other Study ID Numbers: HSC-MS-23-0584
• First Posted: Sep 18, 2023
• Last Update Posted: Sep 18, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Ramesha Papanna, Professor, The University of Texas Health Science Center, Houston: Fetoscopic fetal intervention; Human umbilical cord; NEOX Cord 1K
• Additional relevant MeSH terms: Spinal Dysraphism; Meningomyelocele; Spina Bifida Cystica

Study Results

No Results Posted as of Sep 18, 2023