Fetoscopic NEOX Cord 1K® Spina Bifida Repair

NCT ID: NCT04243889

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-28
• Study Completion Date: 2029-03-12

Brief 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.

Conditions

Spina Bifida; Myelomeningocele; Myeloschisis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 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.

Group Type: EXPERIMENTAL

NEOX Cord 1K

Intervention Type: 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® (HUC) will be used for skin closure at the discretion of the neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.

Interventions

NEOX Cord 1K

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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 Chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance

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 > 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Ramesha Papanna

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramesha Papanna, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

References

Backley S, Bergh EP, Garnett J, Li R, Maroufy V, Jain R, Fletcher S, Tsao K, Austin M, Johnson A, Papanna R. Fetal cardiovascular changes during open and fetoscopic in-utero spina bifida closure. Ultrasound Obstet Gynecol. 2024 Aug;64(2):193-202. doi: 10.1002/uog.27579.

Reference Type: DERIVED

PMID: 38207160 (View on PubMed)

Other Identifiers

HSC-MS-19-1051

Identifier Type: -

Identifier Source: org_study_id