Clinical trials: Complex Perianal Fistulas
Anal Fistula, Complex Perianal Fistula
Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing
The average success rate for healing and remission of complex perianal fistulas, idiopathic or Crohn's-related, is approximately 50%.
- Trial name
- NCT06632418
- Testing
- RhPDGF-BB
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Alexander Hawkins
Crohn's Disease, Complex Perianal Fistula
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.
- Trial name
- NCT04075825
- Testing
- Darvadstrocel
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 150 people
- Sponsor
- Takeda
Crohn's Disease
Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)
The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle…
- Trial name
- ADMIRE-CD-II (NCT03279081)
- Testing
- Cx601
- Where
- 159 sites in United States, Belgium and 13 more
- Volunteers
- 568 people
- Sponsor
- Tigenix S.A.U.
Crohns Disease, Fistula
A Study of Surgical Interventions in Fistulizing Conditions
In this study, participants with complex fistulizing conditions will be treated with surgical interventions according to their clinic's standard practice.
- Conditions
- Crohns Disease, Fistula, Rectovaginal Fistula, Complex Perianal Fistula
- Trial name
- NCT04940611
- Where
- 41 sites in United States, Austria and 8 more
- Volunteers
- 646 people
- Sponsor
- Takeda
Crohn Disease, Complex Perianal Fistula
A Study to Check How Often People Treated With Darvadstrocel for Crohn's Disease Are Diagnosed With Cancer
The main aim is to learn about the risk of cancer after treatment with darvadstrocel compared to other standards of care in people with Crohn's Disease (CD).
- Trial name
- NCT04971525
- Where
- 4 sites in France, Germany and 2 more
- Sponsor
- Takeda
Perianal Fistula
This Study Compares the Conventional Cutting Seton Technique and a GLUBRAN®-Coated Seton in High Perianal Fistula Treatment. The Study Aims to Determine Whether the GLUBRAN®-Coated Seton Improves Healing, Reduces Postoperative Pain and Recurrence, and Better Preserves Anal Continence.
High anal fistula is a complex anorectal condition that can cause persistent pain, purulent discharge, recurrent infection, and a significant reduction in quality of life.
- Trial name
- NCT07676825
- Testing
- Glubran-coated Seton, Seton
- Where
- Egypt
- Volunteers
- 36 people
- Sponsor
- Kasr El Aini Hospital
Anal Fistula
Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease
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.
- Trial name
- FATT1 (NCT00475410)
- Testing
- ASCs (Cx401, company code), Fibrin adhesive
- Where
- 10 sites in Germany, Spain and 1 more
- Volunteers
- 214 people
- Sponsor
- Tigenix S.A.U.
Complex Perianal Fistula, Crohn Disease
Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease
The purpose of this study is to determine safety and efficacy of eASCs (expanded adult stem cells) for treatment of complex perianal fistulas in patients with Crohn's disease.
- Trial name
- FATT (NCT01378390)
- Testing
- Expanded autologous adipose-derived adult stem cells (eASCs)
- Where
- 12 sites in Austria, Netherlands and 1 more
- Volunteers
- 56 people
- Sponsor
- Tigenix S.A.U.
Perianal Fistula, Perianal Crohn Disease
Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases
Consecutive patients with complex anal fistula were prospectively followed for 12 months. Routine MRI was performed before and at 4 and 12 months after surgery. Continence was assessed likewise using a validated questionnaire.
- Conditions
- Perianal Fistula, Perianal Crohn Disease, Anal Fissure, Rectovaginal Fistula
- Trial name
- NCT05709717
- Testing
- Regenerative therapy with SVF-PRP to supplement perianal surgery
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- Kantonsspital Winterthur KSW
Crohn's Disease, Complex Perianal Fistula
A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula
The main aim is to check the long term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn's disease and complex perianal fistula.
- Trial name
- EMPIRE (NCT04118088)
- Testing
- Darvadstrocel
- Where
- 30 sites in Austria, Czechia and 4 more
- Volunteers
- 53 people
- Sponsor
- Takeda
Crohn Disease, Rectal Fistula
A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas
The main aim of the study is to assess the quality of life of people with Crohn's disease after treatment for complex perianal fistulas (CPF) in a standard clinic setting.
- Trial name
- CONFLICT (NCT04876690)
- Where
- 5 sites in Portugal
- Volunteers
- 15 people
- Sponsor
- Takeda
Crohn Disease, Perianal Fistula
Micro-fragmented Adipose Tissue and Complex Crohns' Anal Fistulas
The study aims to evaluate safety, feasibility and effectiveness of local injections of autologous and micro-fragmented adipose tissue obtained with the Lipogems® system in patients with refractory complex fistulizing perianal…
- Trial name
- NCT03555773
- Testing
- Lipogems
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Complex Perianal Fistula
Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula
Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse.
- Trial name
- ANTG-ASC-210 (NCT01314092)
- Testing
- Autologous cultured adipose derived stem cells(low dose group), Autologous cultured adipose derived stem cells(high dose group)
- Where
- 6 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Anterogen Co., Ltd.
Crohn Disease, Inflammatory Bowel Disease
Health-Related Quality of Life in Crohn's Disease Participants With Complex Perianal Fistula Before and After Treatment
The purpose of this study is to assess the impact of treatment (medical and/or surgical) on Health-related Quality of Life (HRQoL) in participants with Crohn's Disease (CD) and Complex Perianal Fistula (CPF), by the Quality of…
- Conditions
- Crohn Disease, Inflammatory Bowel Disease, Gastrointestinal Diseases, Intestinal Diseases
- Trial name
- CALYPSO (NCT04102163)
- Where
- 20 sites in Spain
- Volunteers
- 19 people
- Sponsor
- Takeda
Anal Fistula
Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
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…
- Trial name
- NCT00115466
- Testing
- Non-surgical autologous implant of ASCs
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- Cellerix
Crohn's Disease, Complex Perianal Fistula
A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease
A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present.
- Trial name
- NCT04701411
- Testing
- Darvadstrocel
- Where
- 22 sites in Israel, Japan and 3 more
- Volunteers
- 7 people
- Sponsor
- Takeda
Complex Perianal Fistulas
The Purpose of This Study is to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula
The purpose of this study is to evaluate the safety and efficacy of human TH-SC01 cell injection for the treatment of complex perianal fistulas
- Trial name
- NCT05677672
- Testing
- Human TH-SC01 Cell Injection, Saline solution
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Rectal Fistula
Photodynamic Therapy in Anal Fistula
Objective: Validate and analyze the results of intralesional photodynamic therapy in the treatment of complex anal fistula. Methods: Prospective observational study including patients treated for complex anal fistula who…
- Trial name
- NCT03864718
- Testing
- photodynamic therapy
- Volunteers
- 49 people
- Sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Crohn Disease
Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.
multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to…
- Trial name
- ATTIC (NCT05594862)
- Testing
- Lipogems
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Lipogems International spa
Anal Fistula
Adipose Tissue Injection for the Treatment of Complex Cryptoglandular Perianal Fistula
The incidence of complex cryptoglandular anal fistula is high, it affects eminently young patients and implies an important alteration in their quality of life and high prevalence in sick leave.
- Trial name
- AdiTiF (NCT04790123)
- Testing
- Injection of autologous freshly collected adipose tissue
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Hospital Mutua de Terrassa