Clinical trials: Fistulizing Crohn's Disease
Rectal Fistula
Mesenchymal Stem Cells (MSCs) for Perianal Fistula
OSSM-001 will be evaluated in a double blind, randomized phase I safety study of a single injection of 100 and 300 million bone marrow derived MSCs in 16 patients with refractory perianal fistulas in the setting of Crohn's…
- Trial name
- NCT05407766
- Testing
- OSSM-001
- Sponsor
- Ossium Health, Inc.
Crohn's Disease, Fistulizing Crohn's Disease
AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE)
To evaluate the role of allogeneic mesenchymal stem cells for treatment of perianal fistulizing Crohn disease. Twenty (20) Crohn's disease patients with complex or multiple perianal or rectovaginal fistulas will be included and…
- Conditions
- Crohn's Disease, Fistulizing Crohn's Disease, Stem Cells
- Trial name
- GALENE (NCT02677350)
- Testing
- Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs)
- Sponsor
- Joshua M Hare
Crohn Disease, Perianal Fistula
Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
Crohn's disease is an inflammatory bowel disease characterized by relapses and remissions, causing lesions throughout the digestive tract and accompanied by diarrhea, abdominal pain, and nutritional disorders.
- Conditions
- Crohn Disease, Perianal Fistula, Perianal Fistula Due to Crohn's Disease, Perianal Crohn's Disease
- Trial name
- RIS-PERIANAL (NCT07872449)
- Testing
- Risankizumab
- Where
- 4 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Yuki Horio
Crohn Disease
A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease
A study of infliximab in patients with Fistulizing Crohn's Disease
- Trial name
- NCT00207766
- Volunteers
- 306 people
- Sponsor
- Centocor, Inc.
Crohn's Disease
Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease
This study is a prospective, randomized, parallel, phase 1 trial to assess the safety and feasibility of the transplantation of bone marrow derived mesenchymal stem cells (MSCs) in fistulizing Crohn's disease.
- Trial name
- NCT01874015
- Testing
- mesenchymal cell transplantation, mesenchymal cell and fibroblast injection
- Where
- Iran
- Volunteers
- 10 people
- Sponsor
- Royan Institute
Perianal Crohn Disease, Perianal Fistula
Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease
The purpose of this study is to determine the safety and efficacy of using adult allogeneic bone marrow derived mesenchymal stem cells (MSCs), to treat people for medically refractory perianal fistulizing Crohn's disease.
- Conditions
- Perianal Crohn Disease, Perianal Fistula, Crohn Disease
- Trial name
- PFCD (NCT04519671)
- Testing
- Mesenchymal Stem Cells
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Anthony Lembo
Fistulizing Crohn's Disease
Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease
The primary objective of this study is to investigate the safety and tolerability of locally administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients.
- Trial name
- NCT01624376
- Testing
- DLX105
- Where
- Switzerland
- Volunteers
- 18 people
- Sponsor
- Delenex Therapeutics AG
Perianal Fistula Due to Crohn's Disease
DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing…
- Trial name
- NCT06918808
- Testing
- DB-3Q
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Direct Biologics, LLC
Fistula in Ano, Crohn Disease
Pediatric MSC-AFP Sub-study for Crohn's Fistula
The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease.
- Trial name
- NCT03449069
- Testing
- MSC-AFP
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Mayo Clinic
Crohn's Disease
Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease
The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing…
- Trial name
- ENTERPRISE (NCT02630966)
- Testing
- Vedolizumab
- Where
- 18 sites in United States, Canada and 5 more
- Volunteers
- 34 people
- Sponsor
- Takeda
Anoperineal Lesions, Crohn's Disease Relapse
Description of the Radiological Response of Anoperineal Fistulizing Lesions of Crohn's Disease
The presence of ano-perineal lesions (APL) in Crohn's disease is common and represents a major burden for the patient. More than one-third of patients with Crohn's disease will develop at least one ano-perineal lesion during the…
- Trial name
- PéricrohnIRM (NCT07152977)
- Testing
- Radiological evolution of ano-perineal lesions by MRI
- Where
- France
- Volunteers
- 52 people
- Sponsor
- University Hospital, Rouen
Perianal Crohn's Disease
Stem Cell Fistula Plug in Perianal Crohn's Disease
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
- MSC-AFP (NCT01915927)
- Testing
- MSC-AFP
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- William A. Faubion, M.D.
Crohns Disease
EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment
The primary objective of this study is to assess perianal and perirectal fistula healing (complete closure) based on endoscopic ultrasound (EUS) evaluation at 3 months and by PDAI (Pouchitis Disease Activity Index) and Fistula…
- Trial name
- EUS (NCT01582568)
- Testing
- Certolizumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Baylor College of Medicine
Crohn Disease
Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)
A multi-centre retrospective review of fistulizing Crohn's disease (CD) patient charts will capture data to measure health care resource utilization associated with the use of Infliximab for treatment of CD.
- Trial name
- NCT00705471
- Testing
- Infliximab
- Volunteers
- 42 people
- Sponsor
- Merck Sharp & Dohme LLC
Crohn Disease, Fistula Perianal
Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease
The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease.
- Trial name
- NCT05322057
- Testing
- Darvadstrocel
- Where
- Austria
- Volunteers
- 14 people
- Sponsor
- Medical University of Vienna
Fistulizing Crohn's Disease
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24.
- Trial name
- Divergence2 (NCT03077412)
- Testing
- Filgotinib
- Where
- 27 sites in United States, Austria and 7 more
- Volunteers
- 57 people
- Sponsor
- Gilead Sciences
Crohn's Disease
A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients
This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.
- Trial name
- NCT01355614
- Testing
- QAX576, Infliximab
- Where
- 6 sites in Germany, Switzerland
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Perianal Fistula Due to Crohn's Disease (Disorder)
Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease
This study plans to enroll 10 patients aged 13-17 years of age with refractory perianal fistulizing disease. Patients will be treated by direct injection to the fistula tract(s) with 75 million allogeneic bone marrow derived…
- Trial name
- NCT04791878
- Testing
- Mesenchymal stem cells
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Anthony Lembo
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
Inflammatory Bowel Diseases, Crohn Disease
Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients
The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with inflammatory bowel disease (IBD) in Saudi Arabia where no visits or intervention(s) additional to the…
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Fistulizing Crohn's Disease, Ulcerative Colitis
- Trial name
- NCT03452501
- Testing
- Infliximab
- Where
- 4 sites in Saudi Arabia
- Volunteers
- 157 people
- Sponsor
- Hikma Pharmaceuticals LLC