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NCT04652908 · ClinicalTrials.gov registry record · Phase 1
Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial
A Phase 1 study of Myelomeningocele, sponsored by University of California, Davis.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT04652908: Recruiting Phase 1 study of Myelomeningocele, sponsored by University of California, Davis.
NCT04652908 is a Phase 1 study of Myelomeningocele that is actively recruiting participants, run by University of California, Davis. The registered enrollment target is 55 participants, below the 72-participant average among 8 other Myelomeningocele trials with a reported enrollment target (24% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04652908, a Phase 1 study of Myelomeningocele, is actively recruiting participants, sponsored by University of California, Davis.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Will be assessed by evaluating the presence or absence of cerebrospinal fluid leak, infection at the MMC repair site, failure of the MMC repair site to heal, and any unexpected growths or tumor formation. These will be assessed at birth by physical exam, brain and spinal ultrasound , and brain and spinal MRI.
Conditions Studied
Interventions
- BIOLOGICAL Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix
- OTHER Untreated contemporaneous cohort
Study Locations (1)
California
- UC Davis Health - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-06-21 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
What NCT04652908 shows while recruiting
NCT04652908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 72-participant average among 8 other Myelomeningocele trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Myelomeningocele appearing as the primary indexed condition, and to 2 interventions - of which Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix is the first listed.
NCT04652908 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04652908 about?
NCT04652908 is a clinical study titled "Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial". 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 ...
What is the current status of trial NCT04652908?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2021-06-21. Estimated completion is 2027-03.
What conditions does trial NCT04652908 study?
This clinical trial studies the following conditions: Myelomeningocele.
What interventions are being tested in trial NCT04652908?
The interventions under investigation include: Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix (BIOLOGICAL), Untreated contemporaneous cohort (OTHER).
Who is sponsoring clinical trial NCT04652908?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04652908 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04652908's enrollment target sits among peer trials
55 5th of 8 higher than 4 of 8 other Myelomeningocele trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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