Ignite Creation Date:
2025-12-18 @ 9:46 AM
Ignite Modification Date:
2025-12-23 @ 10:49 PM
Study NCT ID:
NCT02104713
Status:
None
Last Update Posted:
2020-04-30 00:00:00
First Post:
2014-04-01 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stem Cell Therapy to Improve Burn Wound Healing
Sponsor:
None
Organization:
Study Overview
Official Title:
A Pilot Safety Study of the Administration of Mesenchymal Stem Cells (MSC) in the Treatment of Burn Wounds
Status:
None
Status Verified Date:
2020-04
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:
None
Brief Summary:
This study will determine the safety of allogeneic stem cell therapy from healthy donors, for 2nd degree burn wounds of less than 20% Total Body Surface Area (TBSA), at four different dose levels.
Clinical evaluation will take place every 1 to 4 weeks intervals until wound closure, and then monthly for 6 months following the last administration of MSCs.
Once the safety and dose-response analysis in Phase 1 is completed, an expanded trial will be initiated to better examine the efficacy of MSC therapy in 2nd degree burn wounds. Phase 1 will establish the maximum safe dose that will be used in the Phase II trial.
Clinical evaluation will take place every 1 to 4 weeks intervals until wound closure, and then monthly for 6 months following the last administration of MSCs.
Once the safety and dose-response analysis in Phase 1 is completed, an expanded trial will be initiated to better examine the efficacy of MSC therapy in 2nd degree burn wounds. Phase 1 will establish the maximum safe dose that will be used in the Phase II trial.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: