Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial
- Conditions
- Myelomeningocele
- Registration Number
- NCT04652908
- Lead Sponsor
- Diana Lee Farmer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria:<br><br>Eligibility for fetal surgery per the MOMS trial, which are:<br><br> - Myelomeningocele (including myeloschisis) at any level from T1 through S1 with<br> hindbrain herniation. Lesion level will be confirmed by ultrasound and hindbrain<br> herniation will be confirmed by MRI at the UC Davis Fetal Center<br><br> - Maternal age =18 years<br><br> - Gestational age at enrollment between 19 weeks 0 days and 25 weeks 6 days gestation<br> as determined by clinical information and evaluation of first ultrasound<br><br> - Normal karyotype. Results by fluorescence in situ hybridization (FISH) will be<br> acceptable if the patient is greater than 24 weeks gestation;<br><br>Exclusion Criteria:<br><br>Not being eligible for fetal surgery per the MOMS trial, which includes:<br><br> - Multifetal pregnancy<br><br> - Insulin dependent pregestational diabetes<br><br> - Fetal anomaly not related to myelomeningocele.<br><br> - Kyphosis in the fetus of 30 degrees or more<br><br> - Current or planned cerclage or documented history of incompetent cervix, placenta<br> previa or placental abruption<br><br> - Short cervix < 20 mm measured by cervical ultrasound<br><br> - Obesity as defined by body mass index of 35 or greater<br><br> - Previous spontaneous singleton delivery prior to 37 weeks<br><br> - Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal<br> alloimmune thrombocytopenia<br><br> - Maternal HIV or Hepatitis-B status positive due to the increased risk of<br> transmission to the fetus during maternal-fetal surgery. If the patient's HIV or<br> Hepatitis B status is unknown, the patient must be tested and found to have negative<br> results before she can be enrolled<br><br> - Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she<br> does not need to be screened<br><br> - Uterine anomaly such as large or multiple fibroids or Müllerian duct abnormality<br><br> - Other maternal medical condition which is a contraindication to surgery or general<br> anesthesia. This includes any patient with a previous hysterotomy in the active<br> segment of the uterus (whether from a previous classical cesarean, uterine anomaly<br> such as an arcuate or bicornuate uterus, major myomectomy resection, or previous<br> fetal surgery)<br><br> - Patient does not have a support person (e.g., husband, partner, mother)<br><br> - Inability to comply with the travel and follow-up requirements of fetal surgery<br><br> - Patient does not meet other psychosocial criteria (as determined by the psychosocial<br> interviewer) to handle the implications of fetal surgery<br><br> - Participation in another intervention study that influences maternal and fetal<br> morbidity and mortality or participation in this trial in a previous pregnancy;<br><br> - Maternal hypertension which would increase the risk of preeclampsia or preterm<br> delivery (including, but not limited to: uncontrolled hypertension, chronic<br> hypertension with end organ damage and new onset hypertension in current pregnancy)<br><br> - Active COVID-19 infection at time of fetal surgery as determined by positive test
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of the placenta-derived mesenchymal stem cell (PMSC-ECM) Product
- Secondary Outcome Measures
Name Time Method Efficacy of the PMSC-ECM Product