Actively Recruiting
Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial
Led by University of California, Davis · Updated on 2026-01-20
55
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
C
California Institute for Regenerative Medicine (CIRM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myelomeningocele (including myeloschisis) from T1 through S1 with hindbrain herniation confirmed by ultrasound and MRI
- Maternal age 18 years or older
- Gestational age between 19 weeks 0 days and 25 weeks 6 days at enrollment
- Normal fetal karyotype confirmed by testing (fluorescence in situ hybridization acceptable if over 24 weeks gestation)
You will not qualify if you...
- Multifetal pregnancy
- Insulin-dependent pregestational diabetes
- Fetal anomaly unrelated to myelomeningocele
- Fetal kyphosis of 30 degrees or more
- Current or planned cerclage, or history of incompetent cervix, placenta previa, or placental abruption
- Short cervix less than 20 mm by ultrasound
- Maternal obesity with body mass index of 35 or greater
- Previous spontaneous singleton delivery before 37 weeks gestation
- Maternal-fetal Rh isoimmunization, Kell sensitization, or history of neonatal alloimmune thrombocytopenia
- Maternal HIV or Hepatitis-B positive status
- Known Hepatitis-C positive status
- Uterine anomalies such as large or multiple fibroids or Mullerian duct abnormalities
- Other maternal medical conditions contraindicating surgery or anesthesia, including previous hysterotomy in the active uterine segment
- Lack of a support person (e.g., partner, family)
- Inability to comply with travel and follow-up requirements
- Psychosocial criteria not met to handle fetal surgery implications
- Participation in another intervention study affecting maternal or fetal outcomes or prior participation in this trial during another pregnancy
- Maternal hypertension increasing risks of preeclampsia or preterm delivery
- Active COVID-19 infection at time of surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UC Davis Health
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
A
Amy B Powne, MSN, RN
CONTACT
M
Maria G Hernandez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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