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New treatment option for Myelomeningocele
Official title Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial
ClinicalTrials.gov ID: NCT04652908
What this study is testing
What is Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix?
Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for myelomeningocele.
Also referred to as PMSC-ECM.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 25
You may be able to join if
- 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...
- 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...
- Normal karyotype. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is greater than 24 weeks gestation;
You likely can't join if
- 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
See the full eligibility 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...
- 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;
- 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 tested and...
- Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened
- Uterine anomaly such as large or multiple fibroids or Müllerian duct abnormality
- Other maternal medical condition which is a contraindication to surgery or general anesthesia. This includes any patient with a previous hysterotomy in the active segment of the uterus (whether from a previous classical...
- Patient does not have a support person (e.g., husband, partner, mother)
- Inability to comply with the travel and follow-up requirements of fetal surgery
- Patient does not meet other psychosocial criteria (as determined by the psychosocial interviewer) to handle the implications of fetal surgery
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy;
- Maternal hypertension which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in...
- Active COVID-19 infection at time of fetal surgery as determined by positive test
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 weeks to 25 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.