Using cryopreserved human umbilical cord to repair spina bifida in fetuses

Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair: Single Arm Phase III Trial.

This study is testing whether using preserved human umbilical cords can help repair spinal cord defects in fetuses with spina bifida to improve their health and development.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: The University of Texas Health Science Center, Houston (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06042140 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women with a singleton pregnancy and a fetus diagnosed with spina bifida between T1 to S1 vertebral levels.

Not a fit: Patients who may not benefit from this study include those with multiple pregnancies or significant fetal anomalies unrelated to spina bifida.

Why it matters

Potential benefit: If successful, this approach could significantly improve the surgical outcomes and quality of life for fetuses diagnosed with spina bifida.

How similar studies have performed: While this approach is innovative, similar studies using fetal interventions for spina bifida have shown promising results, indicating potential for success.

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

Where this trial is running

Houston, Texas

• 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

Conditions: Spina Bifida, Fetus, Myelomeningocele, Myeloschisis, Fetoscopic fetal intervention, Human umbilical cord, NEOX Cord 1K