Using stem cells to improve fetal surgery for spina bifida
Phase 1/2a Trial of Placental Mesenchymal Stem Cells for Repair of Fetal Myelomeningocele
This study is testing whether adding stem cells to fetal surgery can help improve walking and movement in babies with a severe form of spina bifida.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 19 Weeks to 25 Weeks |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT04652908 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of placental mesenchymal stem cells in conjunction with fetal surgery to repair myelomeningocele, a severe form of spina bifida. Building on previous findings from the MOMS trial, which demonstrated some improvement in motor function with in-utero surgery, this study aims to enhance outcomes by adding stem cells to the surgical procedure. The trial will assess both the safety and efficacy of this combined approach in improving walking ability and overall motor function in affected infants. Participants will be monitored for improvements in their neurological function post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with a diagnosis of myelomeningocele at specific gestational ages and who meet the eligibility criteria outlined in the MOMS trial.
Not a fit: Patients with multifetal pregnancies or other significant fetal anomalies unrelated to myelomeningocele may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance motor function and quality of life for children born with myelomeningocele.
How similar studies have performed: While the MOMS trial showed promise for fetal surgery in myelomeningocele, the addition of stem cells represents a novel approach that has not yet been extensively tested in humans.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sacramento, California
- UC Davis Health — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Diana L Farmer, MD — UC Davis School of Medicine
- Study coordinator: Amy B Powne, MSN, RN
- Email: fctc@health.ucdavis.edu
- Phone: 916-794-2229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.