Clinical trials: Complex Perianal Fistula
Anal Fistula
Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells
Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery
- Trial name
- FISPAC (NCT01803347)
- Testing
- ◦Drug: ASCs. + fibrin glue, fibrin glue
- Where
- 5 sites in Spain
- Volunteers
- 80 people
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Anal Fistula
Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection
The study aims to evaluate effectiveness of the association of endorectal advancement flap technique with local injection of autologous and micro-fragmented adipose tissue, obtained with the Lipogems® system, in patients with…
- Trial name
- Fistula_CM1 (NCT04750499)
- Testing
- Adipose tissue injection associated with endorectal advancement flap.
- Where
- Spain
- Volunteers
- 12 people
- Sponsor
- Hospital Clinic of Barcelona
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.
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
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
Endoscopic Treatment of Complex Anal Fistulas
This is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy and sphincter reconstruction as standard surgical…
- Trial name
- VAAFT (NCT02585167)
- Testing
- operation, VAAFT
- Where
- Denmark
- Volunteers
- 47 people
- Sponsor
- University of Southern Denmark
Complex Perianal Fistula
Long-term Safety and Efficacy of Adipose-derived Stem Cells to Treat Complex Perianal Fistulas in Patients Participating in the FATT-1 Randomized Controlled Trial
The purpose of this extension is to investigate and confirm the long-term (6 months) safety and efficacy of the preceding FATT-1 trial [ClinicalTrials.gov identifier: NTC00475410], which studied patients with perianal fistula…
- Trial name
- LTE (NCT01020825)
- Testing
- ASCs, Fibrin glue
- Where
- 15 sites in Spain
- Volunteers
- 148 people
- Sponsor
- Tigenix S.A.U.
Complex Perianal Fistulas in Adult Participants With Crohn's Disease
Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease
The purpose of this study is to evaluate the efficacy of darvadstrocel for the treatment of complex perianal fistulas in adult participants with Crohn's disease over 24 weeks.
- Trial name
- NCT03706456
- Testing
- Darvadstrocel
- Where
- 11 sites in Japan
- Volunteers
- 22 people
- Sponsor
- Takeda
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
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
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
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.
Perianal Fistula, Primary; Complex
Follow-up Study of Autologous Adipose-derived Stem Cells (ANTG-ASC) for the Complex Fistula (ANTG-ASC-211)
This is an open follow-up clinical trial to evaluate a sustained efficacy and safety of ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II clinical trial.
- Trial name
- ANTG (NCT01623453)
- Testing
- Autologous adipose derived stem cells(low dose group), Autologous adipose derived stem cells(high dose group)
- Where
- 2 sites in South Korea
- Volunteers
- 6 people
- Sponsor
- Anterogen Co., Ltd.
Crohn's Disease
A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease.
The purpose of this study is to asses the efficacy and Safety of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Complex Perianal Fistula in Perianal Crohn's Disease.
- Trial name
- NCT04939337
- Testing
- TH-SC01
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Jinling Hospital, China
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
Fistula Perianal
Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula
Study aim: Safety of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula 2.Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of refractory Anal Fistula…
- Trial name
- NCT05402748
- Testing
- placenta-MSCs derived exosomes
- Where
- Iran
- Volunteers
- 80 people
- Sponsor
- Tehran University of Medical Sciences