Recruiting
Phase 1
Phase 2

Cellular Therapy

Sponsor:

UCLA

Code:

NCT04652908

Conditions

Myelomeningocele

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix

Untreated contemporaneous cohort

Study Details

Brief 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.

Conditions

Myelomeningocele

Study ID

NCT04652908

Start date

Jun 21, 2021

Status verified date

Jan, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 tested and found to have negative results before she can be enrolled
  • 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 cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery)
  • 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 current pregnancy)
  • Active COVID-19 infection at time of fetal surgery as determined by positive test

Study Design

Enrollment

55 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment with PMSC-ECM

One-time administration of PMSC-ECM during the course of in utero fetal myelomeningocele surgery will be administered

other: non-PMSC untreated contemporaneous cohort

Contemporaneous cohort of patients undergoing routine fetal or postnatal MMC repair without PMSC-ECM (non-PMSC untreated contemporaneous cohort).

Interventions

Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix

As in the current standard fetal surgery, under sonographic guidance, initial uterine entry will be accomplished by uterine stapling device or similar. The fetus will be given an intramuscular injection of pain medications and paralytic. The myelomeningocele will be closed in a standardized manner under magnification. As in the standard fetal operation, the spinal cord will be dissected from surrounding tissue and allowed to drop into the spinal canal. The PMSC-ECM product will then be tailored to the size of the spinal cord and applied topically, cell side down. The PMSC-ECM product will be sutured in place to the dura. Finally, the fetal skin will be closed in the standard fashion. The amniotic fluid volume will be replaced and antibiotics will be added. The uterus will be closed. The abdominal fascial layer and skin will be closed in routine fashion.

Untreated contemporaneous cohort

The addition of a non-PMSC treated cohort, the untreated contemporaneous cohort, has been added at the request of the FDA to provide contemporaneous patients for validation of the continued relevance of use of the outcomes of the MOMS trial as the comparison arm for the Phase 2a portion of the study.

Primary outcome measure

  • Safety of the placenta-derived mesenchymal stem cell (PMSC-ECM) Product [ Time Frame: Assessed at birth ]

Central Contacts and Locations

Central contacts

Amy B Powne, MSN, RN

916-794-2229fctc@health.ucdavis.edu

Maria G Hernandez

916-734-4156mghernandez@health.ucdavis.edu

Locations

UC Davis Health

Recruiting

Sacramento, California, United States, 95817

Contacts

Amy B Powne, MSN, RN

916-794-2229fctc@health.ucdavis.edu

Maria G Hernandez

916-734-4156mghernandez@health.ucdavis.edu

Principal Investigator:

Diana L Farmer, MD

More Information

Sponsor

University of California, Davis

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-01-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.