Clinical trials: Digestive System Fistula
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.
Perianal Fistula, Crohn's Disease
Study of ExoFlo for the Treatment of Perianal Fistulas
To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.
- Trial name
- NCT05836883
- Testing
- ExoFlo, Local injection of normal saline
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Direct Biologics, LLC
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 Due to Crohn's Disease, Fistula in Ano
Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
Objectives: Primary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease Secondary: To determine the efficacy of a single/multiple allogeneic…
- Trial name
- NCT05039411
- Testing
- PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
- Where
- Malaysia
- Volunteers
- 5 people
- Sponsor
- CryoCord Sdn Bhd
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.
Esophageal Diseases
Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
The aim of this post-market clinical follow-up study is to evaluate the continued safety and performance of the marketed Evolution® Esophageal Stent System (Partially- and Fully Covered).
- Trial name
- NCT05182255
- Testing
- Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
- Where
- 5 sites in Germany, Spain and 1 more
- Volunteers
- 127 people
- Sponsor
- Cook Research Incorporated
Crohn's Disease
Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
The purpose of this study is to evaluate the efficacy of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease over 24 weeks.
- Trial name
- NCT06925594
- Testing
- Human TH-SC01 cell injection, Saline solution
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Perianal Crohn's Disease
A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is designed to determine the effects of BLI-1300 ointment on perianal pain associated with active Perianal Crohn's Disease (PCD).
- Trial name
- NCT01442363
- Testing
- BLI-1300 low dose, BLI-1300 high dose
- Where
- 17 sites in United States
- Volunteers
- 4 people
- Sponsor
- Braintree Laboratories
Perianal Fistula, Crohn's Disease
A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease
- Trial name
- NCT05626023
- Testing
- Human TH-SC01 cell injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
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
Anal Fistula
A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas
The goal of this clinical trial is to assesses the safety of autologous RD2 Ver.02 as compared to a control for managing transsphincteric and intersphinsteric anal fistulas.
- Trial name
- NCT05641844
- Testing
- RD2 Ver.02, Saline
- Where
- 10 sites in United States, Israel
- Volunteers
- 110 people
- Sponsor
- RedDress Ltd.
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
Crohns Disease
A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease
To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohn's disease who are refractory to one or more standard Crohn's disease therapies.
- Trial name
- NCT01769755
- Testing
- PDA001
- Where
- 12 sites in United States
- Volunteers
- 14 people
- Sponsor
- Celularity Incorporated
Anal Fistula
Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula
The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT…
- Trial name
- LIFT+Graft (NCT01602081)
- Testing
- reinforce soft tissue
- Where
- 8 sites in United States
- Volunteers
- 28 people
- Sponsor
- Cook Group Incorporated
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.
Anal Fistula
Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but with fistula efficacy treatment in 40 to…
- Trial name
- RADIOFIST (NCT03131297)
- Testing
- treatment by radiofrequency
- Where
- 4 sites in France
- Volunteers
- 50 people
- Sponsor
- F Care Systems NV
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