Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579352
Status:
AVAILABLE
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Expanded Access Study of UC-MSC in DMD Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intermediate Size Expanded Access Study of Human Umbilical Cord Mesenchymal Stem Cells UC-MSC In Patients With Duchenne Muscular Dystrophy
Status:
AVAILABLE
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to provide UC-MSC treatment to patients with DMD
Secondary objectives will be to further evaluate treatment-related adverse events as well as changes in DMD-related functional testingassessments blood laboratories and inflammation related biomarker levels over time
Secondary objectives will be to further evaluate treatment-related adverse events as well as changes in DMD-related functional testingassessments blood laboratories and inflammation related biomarker levels over time
Detailed Description:
The study will enroll ambulatory male participants between the ages of 5 and 10 who will receive four 3-day intravenous dose cycles of UC-MSC treatment each administered every three months Participants will be closely monitored throughout the study period for treatment-related adverse events and changes in DMD-related functional assessments at specific follow-up intervals through 24 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: