Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303752
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-25
Brief Title:
Tissue Therapy of Transsphincteric Anal Fistula
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
REP-PAF
Brief Summary:
This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas PAF by the combination of minimal surgical debridement with regenerative cellular therapeutics
Detailed Description:
After being informed about the study and potential risks all patients giving written informed consent will undergo screening serology and preoperative work-up to determine eligibility for study entery Patients who meet the eligibility requirements will be treated for their fistulas by combined minor surgical debridement of the fistula tract and closure of the internal orifice as well as liposuction from the abdominal wall Regenerative cells- enriched lipoaspirate will be injected around the entire length of the fistula tract The first five patients will receive their own regenerative cells and act as donors for the next included patients but they will not be included in the final analysis The rest of the included patients 70 will be randomized in double-blinded manner participant and investigator in a 11 ratio to either recieve own regenerative cells ADRC Adipose-Derived Regeneative Cells or donated cultured regenerative cells ADRC001 All included patients will be scheduled for follow-up at 3 6 and 12 months after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2022-502659-73 | EUDRACT_NUMBER | None | None |