Clinical trials: Perianal Fistula
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.
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
Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
This comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive…
- Trial name
- NCT00115466
- Testing
- Non-surgical autologous implant of ASCs
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- Cellerix
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.
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.
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 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
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
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
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.
Crohn's Disease, Complex Perianal Fistula
A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease
A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present.
- Trial name
- NCT04701411
- Testing
- Darvadstrocel
- Where
- 22 sites in Israel, Japan and 3 more
- Volunteers
- 7 people
- Sponsor
- Takeda
Perianal Fistulas
Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas.
- Trial name
- NCT01462747
- Testing
- KULIST
- Where
- 2 sites in Sweden
- Volunteers
- 28 people
- Sponsor
- Nordic Drugs AB
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 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
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
The Purpose of This Study is to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula
The purpose of this study is to evaluate the safety and efficacy of human TH-SC01 cell injection for the treatment of complex perianal fistulas
- Trial name
- NCT05677672
- Testing
- Human TH-SC01 Cell Injection, Saline solution
- Where
- China
- Volunteers
- 84 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
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
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