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.
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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…
Contacts

Amy B Powne, MSN, RN

916-794-2229

fctc@health.ucdavis.edu

CONTACT

Maria G Hernandez

916-734-4156

mghernandez@health.ucdavis.edu

CONTACT