Umbilical Cord Patch for Spina Bifida (HUC-FICS Trial)

N/A

Recruiting

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new surgical approach to fix spinal cord defects in unborn babies using umbilical cord material.

Who is the study for?

This trial is for pregnant women with a single fetus diagnosed with spina bifida, between 19 and 25+ weeks gestation. Women must be over 18, have a BMI ≤45 kg/m2 without preterm birth risks or previous uterine incisions in the active segment. The fetus should have the defect between T1 to S1 vertebral levels without severe kyphosis or other life-threatening anomalies.

What is being tested?

The study tests using cryopreserved human umbilical cords (NEOX Cord 1K®) as patches during fetoscopic surgery to repair spinal defects caused by spina bifida. It aims to see if this method is effective when applied via laparotomy-assisted fetoscopy.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical surgical risks such as infection, bleeding, and reactions to anesthesia for both mother and fetus. There might also be specific risks related to the use of cryopreserved umbilical cord material.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 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.

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