Clinical trials: Fistulizing Crohn's Disease
Perianal Fistula
Phase 1 Crohn's Pediatric Sub-study of MSC AFP
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20 million cells.
- Trial name
- NCT03014219
- Testing
- Only 1 arm: treatment with MSC-AFP
- Where
- United States
- Sponsor
- William A. Faubion, M.D.
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 (CD), Perianal Crohns Disease
Regenerative Endoscopy in Refractory Perianal Crohn's Disease
Perianal fistulizing Crohn's disease (pCD) represents a severe phenotype of Crohn's disease, affecting approximately 20-30% of patients and resulting in chronic drainage, recurrent sepsis, impaired continence, and reduced quality…
- Trial name
- REPAIR-pCD (NCT07652632)
- Testing
- Autologous Mechanical Tissue Stromal Vascular Fraction (tSVF) Injection
- Where
- 2 sites in India
- Volunteers
- 50 people
- Sponsor
- Asian Institute of Gastroenterology, India
Crohn Disease
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease
The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease.
- Trial name
- NCT00269841
- Testing
- Infliximab 10 mg/kg, Infliximab 5 mg/kg
- Volunteers
- 94 people
- Sponsor
- Centocor, Inc.
Fistulizing Crohns Disease, Perianal Crohns Disease
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.
- Trial name
- FUZION CD (NCT05347095)
- Testing
- Guselkumab
- Where
- 154 sites in United States, Australia and 21 more
- Volunteers
- 288 people
- Sponsor
- Janssen-Cilag Ltd.
Crohn Disease
Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population
Crohn's disease is a inflammatory bowel disease evolving towards the destruction of the intestinal wall resulting in stenosing or perforating complications (fistulas, abscesses).
- Trial name
- NCT05759104
- Testing
- Infliximab, Stomy
- Volunteers
- 40 people
- Sponsor
- Central Hospital, Nancy, France
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 Disease
A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease
This is a study in adults with Crohn's Disease who also have fistulas near the anus. The study has 2 parts. The first part is to find out more about what causes the fistulas.
- Trial name
- NCT03752970
- Testing
- Spesolimab
- Where
- 10 sites in Austria, Belgium and 6 more
- Volunteers
- 27 people
- Sponsor
- Boehringer Ingelheim
Crohn Disease
A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
The main objectives of this study are to evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn's disease who have completed treatment in parent trials and to evaluate the long-term efficacy of…
- Trial name
- NCT04362254
- Testing
- Spesolimab
- Where
- 7 sites in Austria, Belgium and 3 more
- Volunteers
- 12 people
- Sponsor
- Boehringer Ingelheim
Crohn's Disease, Perianal Fistula
MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
This Phase 4, single-arm, open-label study will evaluate the effectiveness and safety of mirikizumab combined with surgical curettage and closure in adults with active perianal fistulizing Crohn's disease.
- Trial name
- MIRICURE (NCT07782021)
- Testing
- Mirikizumab, Fistula Tract Curettage and Closure
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Fistula Vagina, Crohn Disease
Stem Cell Coated Fistula Plug in Patients With Crohn's RVF
The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with rectovaginal fistulizing Crohn's disease.
- Trial name
- NCT03220243
- Testing
- MSC-AFP
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Mayo Clinic
Crohn's Disease
Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease
The current multicentre phase III study is proposed to confirm in an add-on therapy design compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from healthy donors for the treatment of complex…
- Trial name
- ADMIRE-CD (NCT01541579)
- Testing
- Cx601, Saline solution
- Where
- 52 sites in Austria, Belgium and 6 more
- Volunteers
- 278 people
- Sponsor
- Tigenix S.A.U.
Crohn Disease, Infliximab
TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease
This study will compare the efficacy and safety of TDM (therapeutic drug monitoring)-based infliximab (CT-P13, RemsimaTM) intravenous therapy compared with the standard infliximab (RemsimaTM) intravenous therapy for patients with…
- Conditions
- Crohn Disease, Infliximab, Perianal Fistula Due to Crohn's Disease, Therapeutic Drug Monitoring
- Trial name
- NCT06051253
- Testing
- TDM-based infliximab intravenous therapy, Standard infliximab intravenous therapy
- Where
- South Korea
- Volunteers
- 86 people
- Sponsor
- Asan Medical Center
Crohn Disease
Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue
Primary outcome measure: Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred…
- Trial name
- NCT01157650
- Testing
- Autologous mesenchymal stem cells
- Where
- 3 sites in Spain
- Volunteers
- 15 people
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
Crohn Disease
Individual Treatment of Ustekinumab in Perianal Fistulizing Crohn's Disease
This study intends to further explore the actual efficacy of ustekinumab in the individualized treatment of anal fistula Crohn's disease.
- Trial name
- NCT06739278
- Where
- China
- Volunteers
- 119 people
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Inflammatory Bowel Disease (IBD), Crohn Disease
Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study
This study aims to test a new treatment called hyperbaric oxygen therapy (HBOT) for a severe type of inflammatory bowel disease called perianal Crohn's disease (PCD).
- Trial name
- HYPNOTIC (NCT06109961)
- Testing
- Oxygen Gas for Inhalation, Standard of care
- Volunteers
- 54 people
- Sponsor
- University of British Columbia