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Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial

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Conditions

Myelomeningocele

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1/2a Trial of Placental Mesenchymal Stem Cells for Repair of Fetal Myelomeningocele

Quick Facts

Study Start:2021-06-21
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04652908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Weeks to 25 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Maternal age ≥18 years
  3. * 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
  4. * Normal karyotype. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is greater than 24 weeks gestation;
  1. * Multifetal pregnancy
  2. * Insulin dependent pregestational diabetes
  3. * Fetal anomaly not related to myelomeningocele.
  4. * Kyphosis in the fetus of 30 degrees or more
  5. * Current or planned cerclage or documented history of incompetent cervix, placenta previa or placental abruption
  6. * Short cervix \< 20 mm measured by cervical ultrasound
  7. * Obesity as defined by body mass index of 35 or greater
  8. * Previous spontaneous singleton delivery prior to 37 weeks
  9. * Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia
  10. * 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 found to have negative results before she can be enrolled
  11. * Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened
  12. * Uterine anomaly such as large or multiple fibroids or Müllerian duct abnormality
  13. * 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 cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery)
  14. * Patient does not have a support person (e.g., husband, partner, mother)
  15. * Inability to comply with the travel and follow-up requirements of fetal surgery
  16. * Patient does not meet other psychosocial criteria (as determined by the psychosocial interviewer) to handle the implications of fetal surgery
  17. * Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy;
  18. * 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 current pregnancy)
  19. * Active COVID-19 infection at time of fetal surgery as determined by positive test

Contacts and Locations

Study Contact

Maria G Hernandez, CPT1
CONTACT
916-734-4156
mghernandez@ucdavis.edu

Principal Investigator

Diana L Farmer, MD
PRINCIPAL_INVESTIGATOR
UC Davis School of Medicine

Study Locations (Sites)

UC Davis Health
Sacramento, California, 95817
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Diana L Farmer, MD, PRINCIPAL_INVESTIGATOR, UC Davis School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-21
Study Completion Date2026-03

Study Record Updates

Study Start Date2021-06-21
Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

  • Myelomeningocele