Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115466
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-06-22
Brief Title:
Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
Sponsor:
Cellerix
Organization:
Cellerix
Study Overview
Official Title:
Phase II Clinical Trial Multicentre Randomised and Comparative to Evaluate the Efficacy and Safety of a New Therapy With Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
Status:
UNKNOWN
Status Verified Date:
2005-06
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:
None
Brief Summary:
This comparative multicentre randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs Adipose Derived Stem Cells and fibrin glue tissue adhesive material or with fibrin glue alone for the non-surgical treatment of complex perianal fistula
Detailed Description:
Comparative multicentre randomised clinical trial designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs Adipose Derived Stem Cells and fibrin glue tissue adhesive material or with fibrin glue alone for the NON-SURGICAL treatment of complex perianal fistula The closurehealing of the fistula will be evaluated periodically and it will be considered completely closed if there is no suppuration from the external orifice and re-epithelialisation can be observed at 8 weeks after the administration of the randomised therapy
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Nr 04-0211 | None | None | None |