Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652908
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2020-11-25
Brief Title:
Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial
Sponsor:
Diana Lee Farmer
Organization:
University of California Davis
Study Overview
Official Title:
Phase 12a Trial of Placental Mesenchymal Stem Cells for Repair of Fetal Myelomeningocele
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CuRe
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-uterofetal 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
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
Detailed Description:
Historically treatment of MMC was limited to post-natal surgery to close the dura and skin over the spinal cord to prevent meningitis which had no effect on motor function The potential benefit of earlier intervention was realized when prenatal ultrasound of patients with MMC early in gestation revealed near-normal leg movements despite displaying paralysis at birth This finding gave credence to the two-hit hypothesis that paralysis was progressive during prenatal life and suggested that fetal intervention could prevent the secondary damage to the spinal cord Fetal repair of MMC did confer improvement in motor function of children treated in the Management of Myelomeningocele MOMS randomized controlled trial The promising results of the MOMS trial demonstrated the potential for improvement of paralysis for these patients but distal motor function still remained severely impaired in the majority of patients with MMC with standard in utero repair alone While this demonstrated that the ideal time to intervene to prevent paralysis is in utero with the goal of preventing the accrual of ongoing damage to the spinal cord there is still room for improvement The remarkable regenerative capacity of the fetal environment combined with regenerative capacity of placental mesenchymal stem cells offers potential for augmentation of the fetal repair of MMC with a novel therapy to further reduce and repair the sustained spinal cord damage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None