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Procedure

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 30-36 months after delivery

Awards & highlights

HUC-FICS Trial 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.Check my eligibility

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.See study design

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.

HUC-FICS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-36 months after delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30-36 months after delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-36 months after delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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

HUC-FICS 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,860 Total Patients Enrolled

2 Trials studying Spinal Dysraphism

233 Patients Enrolled for Spinal Dysraphism

Ramesha Papanna, MD, MPHPrincipal InvestigatorThe University of Texas Health Science Center, Houston

1 Previous Clinical Trials

50 Total Patients Enrolled

1 Trials studying Spinal Dysraphism

50 Patients Enrolled for Spinal Dysraphism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study accepting new participants at the present time?

"Yes, this investigation is actively seeking participants. The details were initially posted on September 8th 2023 and the entry was recently amended on 9/11/2023 according to clinicaltrials.gov."

Answered by AI

What is the current enrollment for this trial?

"Affirmative. Clinicaltrials.gov reveals that this medical trial, which was posted on September 8th 2023, is actively seeking participants. About one hundred individuals are needed from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ramesha Papanna 2023. "Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042140.

All > Spina Bifida