Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial
Recruiting
Phase 1
Phase 2
Interventional Study
Myelomeningocele
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 Weeks – 25 Weeks
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 55 (estimated)
- Sponsor
- University of California, Davis · Other
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About This Trial
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 …
Trial Locations
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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 Fet…
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