Feasibility and safety of cellular therapy for in-utero repair of myelomeningocele (CuRe Trial): a first-in-human, phase 1, single-arm study.
Diana L Farmer, Priyadarsini Kumar, Elizabeth Reynolds...
https://pubmed.ncbi.nlm.nih.gov/41763744Actively Recruiting
Phase 1
Phase 2
Age: 19Weeks - 25Weeks
All Genders
ID04652908
Phase 1/2a Trial of Placental Mesenchymal Stem Cells to Repair Fetal Myelomeningocele
Led by University of California, Davis · Updated on 2026-01-20
55
Participants Needed
1
Research Sites
N/A
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, specifically myelomeningocele (MMC), is a birth defect causing paralysis, excess brain fluid, and difficulty with bladder and bowel control. Past research showed that surgery before birth reduces the need for brain fluid shunting and slightly improves walking, but most children still cannot walk unassisted. This research investigates whether adding living placental stem cells to fetal MMC repair can enhance walking ability and nerve function by protecting and repairing the spinal cord during early development. The study involves a one-time application of placental mesenchymal stem cells seeded on a dural graft during open fetal surgery to repair MMC. This is compared to a group receiving standard fetal or postnatal MMC repair without stem cells. The stem cell product is tailored and placed on the spinal cord during surgery, followed by standard fetal surgical closure and uterine repair. Participants will undergo fetal surgery and monitoring, with assessments at birth and follow-up at 30 months to evaluate safety and effectiveness. Researchers will assess the safety of the stem cell treatment at birth and measure its impact on motor function and other outcomes up to 30 months. This trial includes detailed clinical evaluations and ongoing monitoring to understand the treatment's effects over time.
CONDITIONS
Brief Title
Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial
Who Can Participate
Age: 19Weeks - 25Weeks
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of myelomeningocele (including myeloschisis) from T1 to 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 (FISH acceptable after 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, history of incompetent cervix, placenta previa, or placental abruption
- Short cervix less than 20 mm by ultrasound
- Maternal obesity with BMI 35 or greater
- Previous spontaneous singleton delivery before 37 weeks
- Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia history
- Maternal HIV or Hepatitis B positive status
- Known Hepatitis C positive status
- Uterine abnormalities such as large fibroids or Müllerian duct anomalies
- Medical conditions contraindicating surgery or anesthesia, including prior uterine surgery in active segment
- Lack of a support person
- Inability to comply with travel and follow-up requirements
- Psychosocial factors preventing handling fetal surgery implications
- Participation in other intervention studies affecting maternal or fetal outcomes
- Maternal hypertension increasing preeclampsia or preterm delivery risk
- Active COVID-19 infection at time of fetal surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - One-time procedure during pregnancy
Participants receive one-time administration of placental mesenchymal stem cells seeded on a dural graft during fetal surgery to repair myelomeningocele.
1 surgical visit (in-person)
Follow-up
Duration - Up to 30 months after birth
Participants are monitored for safety and efficacy outcomes of the treatment, including assessments at birth and up to 30 months of age.
Multiple follow-up visits for assessments up to 30 months
Trial Site Locations
Total: 1 location
1
UC Davis Health
Sacramento, California, United States, 95817
Actively Recruiting
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Research Team
A
Amy B Powne, MSN, RN
M
Maria G Hernandez
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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