Anal Fistula Clinical Trial
Official title:
Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics
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.
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 1:1 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06092398 -
Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula
|
N/A | |
| Active, not recruiting |
NCT06243302 -
Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration
|
||
| Terminated |
NCT02423330 -
A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula
|
Early Phase 1 | |
| Completed |
NCT01012843 -
Do Antibiotics Prevent Anal Fistulae Formation?
|
N/A | |
| Recruiting |
NCT04750499 -
Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection
|
N/A | |
| Not yet recruiting |
NCT04541238 -
Imaging Template for Reporting Anal Fistula
|
||
| Recruiting |
NCT05044182 -
Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula
|
N/A | |
| Recruiting |
NCT03690934 -
Treatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).
|
N/A | |
| Recruiting |
NCT01388257 -
Anal Crohn Fistula Surgery
|
N/A | |
| Active, not recruiting |
NCT00115466 -
Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
|
Phase 2 | |
| Not yet recruiting |
NCT03311035 -
LIFT Technique Versus Seton in Management of Anal Fistula
|
N/A | |
| Recruiting |
NCT04790123 -
Adipose Tissue Injection for the Treatment of Complex Cryptoglandular Perianal Fistula
|
N/A | |
| Completed |
NCT05605080 -
Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
|
N/A | |
| Recruiting |
NCT04119700 -
Fistulectomy and Primary Sphincter rEconstruction vs. endorectaL Advancement Flap in the Treatment of High Anal Fistulas
|
N/A | |
| Recruiting |
NCT01997645 -
Surgical Treatment of High Perianal Fistulas
|
N/A | |
| Terminated |
NCT01584752 -
Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas
|
||
| Completed |
NCT04811105 -
INVESTIGATION OF THE EFFICACY OF FISTULA OBLITERATION BY STEAM ABLATION IN PERİANAL FISTULAS
|
N/A | |
| Not yet recruiting |
NCT05476146 -
Re-routing in Treatment High Anal Fistula
|
N/A | |
| Recruiting |
NCT04616911 -
Rerouting Seton Versus LIFT for Complex Anal Fistula
|
N/A | |
| Completed |
NCT03345511 -
Ultrasound Guided Caudal Block for Benign Anal Surgery
|
N/A |