Stem cells may help babies with spina bifida walk better
NCT ID NCT04652908
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for pregnant women carrying a baby with spina bifida, a birth defect that can cause paralysis and other problems. Researchers are adding living stem cells from the placenta to the standard fetal surgery, hoping to protect the spinal cord and improve the child's ability to walk. The trial will check if this approach is safe and works better than surgery alone in 55 participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2021
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 25 weeks
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UC Davis Health
RECRUITINGSacramento, California, 95817, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Spinal zaps may boost leg strength in kids with spina bifida
- Womb surgery breakthrough: two methods to fix spina bifida before birth
- Timing of breathing tube removal may impact newborn spina bifida recovery
- Fetal surgery immune mystery: why do some babies arrive too early?
- Which enema works best for spina bifida? new study seeks answers