Clinical trials: Complex Perianal Fistula
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
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 Using Artificial Intelligence to Identify Adults With Complex Perianal Fistulas Associated With Crohn's Disease
Natural Language Processing and machine learning are examples of artificial intelligence tools. This study will check if these tools correctly identify people with Crohn's disease with complex perianal fistulas from their medical…
- Trial name
- INTUITION-CPF (NCT04844593)
- Where
- 3 sites in Spain
- Volunteers
- 32 people
- 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 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 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
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
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
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.
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
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
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
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
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.
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
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 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'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, 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.