Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Dec 2, 2020

Keywords

ClinConnect Summary

The CuRe Trial is studying a new treatment for myelomeningocele (MMC), a serious birth defect commonly known as spina bifida. This condition can lead to challenges such as paralysis and problems with bladder and bowel control. This trial is looking at whether adding living stem cells from the placenta to a special type of surgery performed before birth can help improve walking ability in babies with MMC. Previous research in animals showed that these stem cells might protect the spinal cord and improve movement and other functions.

To participate in the trial, mothers must be at least 18 years old and have a confirmed diagnosis of myelomeningocele, among other criteria. They also need to be between 19 and 25 weeks pregnant. Participants can expect careful monitoring throughout the process to ensure safety and effectiveness of this new approach. It’s important to note that certain health conditions may prevent eligibility, and support from a partner or family member is required. This trial aims to provide valuable insights that could lead to better outcomes for children with MMC.

Gender

ALL

Eligibility criteria

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