Clinical trials: Perianal Crohn Disease
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.
Inflammatory Bowel Disease, Perianal Fistula
Perianal Fistula (PAF) Validation and Burden of Illness Study
The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.
- Conditions
- Inflammatory Bowel Disease, Perianal Fistula, Crohns Disease
- Trial name
- NCT03981939
- Testing
- No intervention
- Where
- Canada
- Volunteers
- 3,032 people
- Sponsor
- Takeda
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, 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
Anal Fistula, Complex Perianal Fistulas
Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula
The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
- Conditions
- Anal Fistula, Complex Perianal Fistulas, Crohn's Disease
- Trial name
- NCT06429241
- Testing
- Mesenchymal Stem Cells (MSCs)
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
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.
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's Disease
A Survey of Darvadstrocel in People With Crohn's Disease
This study is a survey in Japan of Darvadstrocel injection used to treat Crohn's disease people with complicated anal fistula. The study sponsor will not be involved in how the participants are treated but will provide…
- Trial name
- J-INSPIRE (NCT05113095)
- Testing
- Darvadstrocel
- Where
- Japan
- Volunteers
- 275 people
- Sponsor
- Takeda
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
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
Perianal Fistula, Crohn's Disease
Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)
A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional…
- Trial name
- NCT04847739
- Testing
- Seton Placement, AVB-114
- Where
- 15 sites in United States
- Volunteers
- 60 people
- Sponsor
- Avobis Bio, LLC
Perianal Fistula Due to Crohn's Disease
Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection
The goal of this Expanded Access Protocol is to provide expanded access of AVB-114 to patients who had their fat tissue collected as part of a clinical trial (STOMP-II), but who were subsequently not treated with AVB-114 because…
- Trial name
- EAP-STOMP2 (NCT06509828)
- Testing
- AVB-114
- Sponsor
- Avobis Bio, LLC
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, 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
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
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, Anal Fistula
Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.
The purpose of this study is to asses the safety and efficacy of adipose-derived adult stem cells from healthy donnors for treatment of complex perianal fistulas in Crohn's disease.
- Trial name
- NCT01372969
- Testing
- Cx601
- Where
- 6 sites in Spain
- Volunteers
- 24 people
- Sponsor
- Tigenix S.A.U.
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
Perianal Crohns'
Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
The purpose of this study is to evaluate the blood levels of Metronidazole after application to the peri anal area after a single dose and 6 or 7 days application.
- Trial name
- NCT00774969
- Testing
- Metronidazole
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- S.L.A. Pharma AG