Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06042140

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

Led by The University of Texas Health Science Center, Houston · Updated on 2025-08-13

100

Participants Needed

1

Research Sites

678 weeks

Total Duration

On this page

Sponsors

T

The University of Texas Health Science Center, Houston

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female with singleton pregnancy
  • Gestational age between 19 and 25 5/7 weeks at screening and 22 to 25 6/7 weeks at surgery
  • Maternal age 18 years or older
  • Pre-pregnancy body mass index of 45 kg/m2 or less
  • No risk factors for preterm birth such as short cervix less than 20 mm or previous preterm delivery
  • No previous uterine incision in the active uterine segment
  • Willingness to undergo open fetal repair if fetoscopic surgery is unsuccessful
  • Fetus diagnosed with spina bifida defect between T1 and S1 vertebral levels
  • Fetus has Chiari II malformation
  • No evidence of fetal spinal kyphosis
  • No major life-threatening fetal anomalies unrelated to spina bifida
  • Normal fetal karyotype, normal chromosomal microarray analysis, or chromosomal microarray with variants of unknown significance (fluorescence in situ hybridization acceptable if 24 weeks or older)
Not Eligible

You will not qualify if you...

  • Non-resident of the United States
  • Multifetal pregnancy
  • Poorly controlled insulin-dependent pregestational diabetes or poorly controlled insulin-dependent A2 diabetes mellitus
  • Current or planned cerclage or history of incompetent cervix
  • Placenta previa or placental abruption
  • Short cervix less than 20 mm
  • Obesity with body mass index over 45 kg/m2
  • Previous spontaneous singleton delivery before 37 weeks gestation
  • Maternal-fetal Rh isoimmunization, Kell sensitization, or history of neonatal alloimmune thrombocytopenia
  • HIV, Hepatitis B, or Hepatitis C positive status
  • Uterine anomalies such as large or multiple fibroids or mullerian duct abnormalities that cannot be avoided during surgery
  • Other medical conditions contraindicating surgery or general anesthesia
  • Lack of a support person
  • Inability to comply with travel and follow-up requirements
  • Failure to meet psychosocial standardized assessment criteria
  • Participation in other intervention studies affecting maternal or fetal outcomes
  • Maternal hypertension
  • Zika virus positivity
  • Allergy or history of drug reaction to Amphotericin B
  • Fetal major anomalies unrelated to spina bifida
  • Fetal kyphosis of 30 degrees or more
  • Ventriculomegaly greater than 15 mm with no movements at hip and knee joints

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

Loading map...

Research Team

R

Ramesha Papanna, MD, MPH

CONTACT

S

Stephanie W Conaway, BSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here