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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Sep 11, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new surgical method for treating spina bifida in unborn babies. Specifically, it aims to see if using cryopreserved human umbilical cords can effectively cover defects in the spinal cord during a minimally invasive surgery called fetoscopic repair. This study is currently looking for pregnant women who are between 19 and 25 weeks along and have a single baby with a spina bifida defect located between the T1 and S1 vertebrae. To participate, mothers need to be at least 18 years old, be in good health, and not have certain pregnancy complications.

If enrolled in the study, participants can expect to undergo a fetoscopic surgery, which is less invasive than traditional surgery, to help repair the defect in their baby's spine. If that approach doesn’t work, they may need to have a more invasive surgery. The trial is focused on ensuring the safety and effectiveness of this innovative treatment, which could potentially improve outcomes for babies with spina bifida. It's important for potential participants to be aware of the eligibility criteria and to have a support person throughout the process, as well as to follow up with the study team after the procedure.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Maternal Inclusion Criteria:
• • 1. Singleton pregnancy
• • 2. Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks
• • 3. Maternal age: 18 years and older
• • 4. Body mass index ≤45 kg/m2 (pre-pregnancy)
• • 5. No preterm birth risk factors (short cervix \<20 mm or a history of previous preterm delivery)
• • 6. No previous uterine incision in the active uterine segment
• • 7. Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful
• Fetal Inclusion Criteria:
• • 1. Spina bifida defect between T1 to S1 vertebral levels
• • 2. Chiari II malformation
• • 3. No evidence of kyphosis (curved spine)
• • 4. No major life-threatening fetal anomaly unrelated to spina bifida
• • 5. Normal karyotype, or a normal chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance \[fluorescence in situ hybridization (FISH) acceptable if ≥ 24 weeks\].
• Exclusion Criteria:
• Maternal Exclusion Criteria:
• • 1. Non-resident of the United States
• • 2. Multifetal pregnancy
• • 3. Poorly controlled insulin-dependent pregestational diabetes
• • 4. Poorly controlled A2 diabetes mellitus (A2DM) insulin-dependent diabetes
• • 5. Current or planned cerclage or documented history of an incompetent cervix
• • 6. Placenta previa or placental abruption
• • 7. Short cervix of \< 20 mm
• • 8. Obesity as defined by a body mass index of \> 45 kg/m2
• • 9. Previous spontaneous singleton delivery prior to 37 weeks
• • 10. Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal alloimmune thrombocytopenia
• • 11. HIV or Hepatitis-B positive status
• • 12. Known Hepatitis-C positivity
• • 13. 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
• • 14. Other medical conditions which are contraindication to surgery or general anesthesia
• • 15. Patient does not have a support person
• • 16. Inability to comply with the travel and follow-up requirements of the trial
• • 17. Patient does not meet psychosocial standardized assessment criteria
• • 18. Participation in this or another intervention study that influences maternal and fetal morbidity and mortality
• • 19. Maternal hypertension
• • 20. Zika virus positivity
• • 21. Allergy/history of drug reaction to Amphotericin B
• Fetal exclusion criteria:
• • 1. Major fetal anomaly not related to spina bifida
• • 2. Kyphosis in the fetus of 30 degrees or more
• • 3. Ventriculomegaly greater than 15 mm and no movements noted at hip and knee joints