NCT04652908 Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial
| NCT ID | NCT04652908 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of California, Davis |
| Condition | Myelomeningocele |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2021-06-21 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 55 participants in total. It began in 2021-06-21 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Spina bifida, or myelomeningocele (MMC), is a birth defect that results in paralysis, excess fluid on the brain (hydrocephalus), and impaired ability to urinate and have bowel movements normally. In a previous study (the MOMS trial), surgery before birth (in-utero/fetal surgery) was shown to reduce the need for shunting for hydrocephalus. There was also some improvement in ambulation, but 58 % of the children still could not walk unassisted. This study is testing living stem cells from placenta added to the fetal repair in an effort to improve the ability to walk. Previous animal studies have shown dramatic improvement in walking and bowel and bladder function when placental stem cells are added to MMC repair. Use of these "living" cells may protect the developing spinal cord, prevent further injury, and may even reverse existing damage to the nerves that control movement. This study is assessing the safety and efficacy of adding stem cells to open fetal surgery for MMC in humans.
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
Contact & Investigator
Diana L Farmer, MD
PRINCIPAL INVESTIGATOR
UC Davis School of Medicine
Frequently Asked Questions
Who can join the NCT04652908 clinical trial?
This trial is open to participants of all sexes, aged 19 Weeks or older, up to 25 Weeks, studying Myelomeningocele. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04652908 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04652908 currently recruiting?
Yes, NCT04652908 is actively recruiting participants. Contact the research team at fctc@health.ucdavis.edu for enrollment information.
Where is the NCT04652908 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT04652908 clinical trial?
NCT04652908 is sponsored by University of California, Davis. The principal investigator is Diana L Farmer, MD at UC Davis School of Medicine. The trial plans to enroll 55 participants.