Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04890574
Status:
UNKNOWN
Last Update Posted:
2022-03-15
First Post:
2021-04-29
Brief Title:
CellMist Autologous Cells to Treat Deep Second-Degree Burns
Sponsor:
RenovaCare Inc
Organization:
RenovaCare Inc
Study Overview
Official Title:
An Open Label Pilot Study to Evaluate the CellMist System in the Treatment of Deep Second Degree IIoB Burn Injuries With Autologous Skin Cells
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
CELLMIST1
Brief Summary:
The overall purpose of this study is to evaluate the safety of the CellMist System in the treatment of deep second degree burns IIB in a prospective multicenter feasibility pilot study
Detailed Description:
Patients between the ages of 18 and 65 years of age inclusive with a 30 Total Body Surface Area TBSA that requires surgical or enzymatic debridement and split thickness skin grafting STSG on any body surface excluding the face joints perineum and hands will be considered for participation in this study CellMist solution autologous epidermal and dermal cells will be administered via the System Skin Gun will be evenly distributed to aid in burn healing Healing pain and treatment-related adverse events will be evaluated at follow-up visits Data concerning safety of the CellMist System will be collected Safety will be evaluated in terms of treatment and serious related adverse events
Each subject will participate in up to 9 total visits screening treatment and 7 follow-up study visits over a period of 52 weeks Up to 14 subjects will be enrolled and treated within this at up to 4 institutions
Each subject will participate in up to 9 total visits screening treatment and 7 follow-up study visits over a period of 52 weeks Up to 14 subjects will be enrolled and treated within this at up to 4 institutions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None