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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04652908
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Myelomeningocele

Eligibility Criteria

Sex
ALL
Age
19 Weeks - 25 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix — BIOLOGICAL
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 21, 2021
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
55 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis HealthSacramentoCalifornia95817
Amy B Powne, MSN, RN
[email protected]
916-794-2229
Maria G Hernandez
[email protected]
916-734-4156
Diana L Farmer, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UC Davis Health· Sacramento, CA

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