Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial (NCT04652908) | Clinical Trial Compass
RecruitingPhase 1/2
Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial
United States55 participantsStarted 2021-06-21
Plain-language summary
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.
Who can participate
Age range19 Weeks – 25 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 te…
What they're measuring
1
Safety of the placenta-derived mesenchymal stem cell (PMSC-ECM) Product