Using cryopreserved human umbilical cord to repair spina bifida in fetuses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a laparotomy-assisted fetoscopic surgical technique that utilizes cryopreserved human umbilical cords (NEOX Cord 1K®) to cover spinal cord defects associated with spina bifida. The procedure is designed for fetuses diagnosed with spina bifida between specific vertebral levels and involves applying the umbilical cord tissue as a meningeal and skin patch. The study will assess the outcomes of this innovative approach in improving fetal health and development.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Ramesha Papanna, MD, MPH — The University of Texas Health Science Center, Houston
• Study coordinator: Ramesha Papanna, MD, MPH
• Email: Ramesha.Papanna@uth.tmc.edu
• Phone: (713) 500-6423

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.