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Tissue Graft

Fetoscopic Umbilical Cord Repair for Spina Bifida

N/A

Waitlist Available

Led By Ramesha Papanna, MD, MPH

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maternal: Age 18 years and older

Fetal: Normal karyotype, or normal CMA, or a CMA with variants of unknown significance

Must not have

Maternal: HIV or Hepatitis-B positive status

Maternal: Obesity as defined by a body mass index of > 40 kg/m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 ± 2 months, 30-36 months and 60-66 months post birth

Awards & highlights

No Placebo-Only Group

Summary

This trial will use NEOX Cord 1K®, which are cryopreserved human umbilical cord allografts, to cover spina bifida defects in order to decrease the rates of postnatal morbidities.

Who is the study for?

This trial is for pregnant women over 18 with a single pregnancy, carrying fetuses with spina bifida but no other major unrelated anomalies or kyphosis. The fetus must have a normal karyotype and the defect between T1 to S1 vertebral levels. Women must be within a specific gestational age range, have no significant health risks or previous preterm deliveries, and BMI under 40 kg/m2.

What is being tested?

The trial tests the use of NEOX Cord 1K®, cryopreserved human umbilical cord allografts, applied via fetoscopy as a cover for spina bifida defects in fetuses. It aims to create a watertight seal on the spinal cord to reduce postnatal complications and may also serve as skin cover for larger defects.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical surgical risks such as infection at the surgery site, reaction to anesthesia, premature labor or delivery due to surgical intervention, and possible harm to the fetus during procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My unborn baby's genetic tests are normal or show unknown changes.

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My unborn baby has been diagnosed with Chiari II malformation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV or Hepatitis-B positive.

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My BMI is over 40, classifying me as obese.

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I have health issues that make surgery or anesthesia risky.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 ± 2 months, 30-36 months and 60-66 months post birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 ± 2 months, 30-36 months and 60-66 months post birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 ± 2 months, 30-36 months and 60-66 months post birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with successful fetoscopic repair of the defect using NEOX Cord 1K®

Other study objectives

Assessment of Arnold-Chiari malformation II

Bowel function assessments bowel movements.

Urodynamic function assessments

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NEOX Cord 1K applied fetoscopicallyExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met