Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475410
Status:
COMPLETED
Last Update Posted:
2019-04-12
First Post:
2007-05-17
Brief Title:
Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohns Disease
Sponsor:
Tigenix SAU
Organization:
Takeda
Study Overview
Official Title:
A Phase III Multicenter Single Blind Randomized Comparative and add-on Clinical Trial in Three Parallel Groups to Evaluate Efficacy and Safety of a New Therapy With Adipose-derived Autologous Stem Cells for the Treatment of Complex Perianal Fistulas in Patients Without Inflammatory Bowel Disease
Status:
COMPLETED
Status Verified Date:
2019-04
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:
FATT1
Brief Summary:
Anal fistula is defined as an abnormal communication between the anal canal and the perianal skin Adipose-derived stem cells are a new therapy for the closure of these fistulas This study will test the safety and efficacy of ASCs adipose stem cells in the treatment of patients without Crohns disease
Detailed Description:
Perianal fistula accounts for 10 to 30 of coloproctological surgical procedures Currently accepted conventional treatment is surgery intended to treat the tracts using different technical options This surgery usually has a highly bothersome postoperative period and may involve two major complications anal incontinence and recurrence The biological properties of stem cells derived from adult tissues make them adequate candidates for the treatment of diseases in which tissues are damaged or the healing process is altered This study will compare the efficacy of ASCs versus ASCs plus Fibrin adhesive versus Fibrin adhesive alone for closure of complex perianal fistulas not associated to Inflammatory Bowel Disease Fistula closure is defined as absence of suppuration and re-epithelization of the external opening in the clinical evaluation and absence of collections 2 cm directly related to the fistula tract treated as measured by MRI
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 |
|---|---|---|---|
| 2006-003370-95 | OTHER | EMEA | None |