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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 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.

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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.

Conditions Studied

Myelomeningocele

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

FieldValue
Enrollment Target 55 participants
Start Date 2021-06-21
Est. Completion 2027-03
Phase Phase 1

Sponsor

University of California, Davis

657 total trials

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What the Registry Record Tells You About NCT04652908

The ClinicalTrials.gov registry entry for NCT04652908 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 72-participant average among 8 other Myelomeningocele trials with a reported enrollment target (24% lower). The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.