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)

Study Purpose

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 finger compression, and absence of collections greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Signed informed consent. 2. Participants of either gender greater than or equal to (>=) 18 years and less than or equal to (<=) 75 years of age. 3. Participants with CD diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria. 4. Presence of complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment; a central reading of a locally performed contrast enhanced (gadolinium) pelvic MRI will be performed to confirm location of the fistula and potential associated perianal abscess(es). Fistula(s) must have been draining for at least 6 weeks prior to Screening visit. Actively draining simple subcutaneous fistula(s), at the time of Screening visit, are not allowed in this study. A complex perianal fistula is defined as a fistula that meets one or more of the following criteria :
  • - High inter-sphincteric, high trans-sphincteric, extra-sphincteric or suprasphincteric.
  • - Presence of >=2 external openings.
  • - Associated perianal abscess(es).
Note: Abscesses that are larger than 2 cm at least 2 dimensions on MRI must be confirmed to have been drained adequately by the surgeon during the preparation curettage in order to be eligible. 5. Clinically controlled, nonactive or mildly active CD, during the last six months prior to Screening visit with:
  • - A patient reported outcomes (PRO-2) score <14 at Screening, AND - A colonoscopy documenting the absence of ulcers larger than 0.5 cm in the colonic mucosa: - If colonoscopy data are not available within 6 months prior to Screening: - A simple endoscopic score for Crohn's Disease (SES-CD) <=6 with absence of rectal ulcers larger than 0.5 cm must be documented in a colonoscopy performed at Screening before randomization.
  • - If colonoscopy data are available within 6 months prior to Screening, the following must be documented, otherwise a new colonoscopy (as above) will be mandatory: - The absence of ulcers larger than 0.5 cm in the colonic mucosa AND - the improvement or no worsening in abdominal pain and/or in the diarrhea, sustained for one week or more, since the last colonoscopy was performed in the clinical records until Screening visit.
AND o No hemoglobin decrease >=2.0 gram per deciliter (g/dL) or an unexplained rising C-reactive protein (CRP), > 5.0 milligram per liter (mg/L) to a concentration above the referenced upper limit of normal (ULN) (unless the rise is due to a known process other than luminal Crohn's Disease), since the last colonoscopy was performed as compared to results during the Screening visit. AND o no initiation or intensification of treatment with corticosteroids, immunosuppressants or monoclonal antibodies (mAbs) dose regimen since the last endoscopy up to Screening visit. 6. Participants whose perianal fistulas were previously treated and have shown an inadequate response or a loss of response while they were receiving either an immunosuppressive agent or tumour necrosis factor (TNF)-alpha antagonist or vedolizumab or ustekinumab, or having documented intolerance to any of these treatments administered at least at approved or recommended doses during the minimum period mentioned:
  • - Immunosuppressive agents: at least 3 months treatment with azathioprine (2-3 milligram per kilogram per day [mg/kg/day]), 6-mercaptopurine (1-1.5 mg/kg/day), or subcutaneous/intramuscular methotrexate (25 mg/week) prior to Screening for the study.
  • - TNFalpha antagonists: - Infliximab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study.
For induction: 1 intravenous dose of 5 milligram per kilogram (mg/kg) followed by the same dose 2 and 6 weeks after. For maintenance: 5-10 mg/kg intravenously every 8 weeks, or more frequently.
  • - Adalimumab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn's disease prior to screening for the study.
For induction: 1 subcutaneous dose of 160 milligram (mg), followed by 80 mg 2 weeks after. For maintenance: 40 mg subcutaneously every other week, or weekly.
  • - Certolizumab l: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study.
For induction: 1 subcutaneous dose of 400 mg, followed by the same dose 2 and 4 weeks after. For maintenance: 400 mg subcutaneously every 2 to 4 weeks.
  • - Anti-integrin: at least 14 weeks treatment of the approved dose for induction and/or maintenance in Crohn´s disease prior to screening for the study.
For induction: Vedolizumab 300 mg. For maintenance: Vedolizumab 300 mg every 4 to 8 weeks.
  • - Anti-interleukin (IL)-12/23: at least 16 weeks treatment of the approved dose in Crohn´s disease prior to screening for the study.
For induction: Ustekinumab, approximately 6mg/kg intravenously initially then followed by 90 mg subcutaneously every 8 weeks. 7. Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 international units [IU] human chorionic gonadotropin [hCG]). Both WCBP or male participants participating in this study, with a WCBP as partner, must agree to use an adequate method of contraception during the entire duration of the study. An adequate method of contraception is defined as complete, non-periodic sexual abstinence (refraining from heterosexual intercourse), single-barrier method, vasectomy, adequate hormonal contraception (to have started at least 7 days prior to Screening visit), or an intra-uterine device (to have been in place for at least 2 months prior to Screening visit).

Exclusion Criteria:

1. Concomitant rectovaginal or rectovesical fistula(s). 2. Participant naïve to prior specific medical treatment for complex perianal fistula(s) including immunosuppressant (IS) or anti-TNFs. 3. Presence of a perianal collection >2 cm in at least two dimensions on the central reading MRI at Screening visit that was not adequately drained as confirmed by the surgeon during the preparation procedure (week -3 to day 0). 4. Severe rectal and/or anal stenosis and/or severe proctitis (defined as the presence of large >0.5 cm ulcers in the rectum) that make impossible to follow the surgery procedure manual. 5. Participant with diverting stomas. 6. Active, uncontrolled infection requiring parenteral antibiotics. 7. Participant with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to the Preparation visit. 8. Participants with major alteration on any of the following laboratory tests or increased risk for the surgical procedure:
  • - Serum creatinine levels >1.5 times the ULN - Total bilirubin >1.5 ULN - Aspartate Transaminase (AST)/ Alanine Transaminase (ALT) >3 times ULN - Hemoglobin <10.0 g/dL - Platelets <75.0*10^9/L - Albuminemia <3.0 g/dL 9.
Suspected or documented infectious enterocolitis within two weeks prior to Screening visit. 10. Any prior invasive malignancy diagnosed within the last 5 years prior to Screening visit. Participants with basal-cell carcinoma of the skin completely resected outside the perineal region can be included. 11. Current or recent (within 6 months prior to the Screening visit) history of severe, progressive, and/or uncontrolled hepatic, haematological, gastrointestinal (GI) (other than CD), renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease that may result in participants increased risk from study participation and/or lack of compliance with study procedures. 12. Participants with primary sclerosing cholangitis. 13. Participants with known chronically active hepatopathy of any origin, including cirrhosis and participants with persistent positive Hepatitis B Virus (HBV) surface antigen (HBsAg) and quantitative HBV polymerase chain reaction (PCR), or positive serology for Hepatitis C Virus (HCV) and quantitative HCV PCR within 6 months prior to Screening. 14. Congenital or acquired immunodeficiencies, including participants known to be HIV carriers 15. Known allergies or hypersensitivity to penicillin or aminoglycosides; Dulbecco Modified Eagle's Medium (DMEM); bovine serum; local anaesthetics or gadolinium (MRI contrast). 16. Contraindication to MRI scan (example, due to the presence of pacemakers, hip replacements or severe claustrophobia). 17. Severe trauma within 6 months prior to Screening visit. 18. Pregnant or breastfeeding women. 19. Participants who do not wish to or cannot comply with study procedures. 20. Participants currently receiving, or having received any investigational drug within 3 months prior to Screening visit. 21. Participants previously treated with Cx601 or other allogeneic stem-cell therapy cannot be enrolled into this clinical study. 22. Any major surgery of the GI tract (including one or more segments of the colon or terminal ileum) within 6 months prior the screening or any minor surgery of the GI tract within 3 months prior to screening. 23. Participants who had local perianal surgery other than drainage for the fistula within 6 months prior to the Screening visit, or those who may need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study. 24. Contraindication to the anaesthetic procedure.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03279081
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Tigenix S.A.U.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Puerto Rico, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Additional Details

This study is to assess the efficacy and safety of Cx601, eASC, for the treatment of complex perianal fistulas in participants with Crohn's disease. The study will randomize approximately 554 participants.

  • - Cx601 eASCs intralesional injection - Placebo - Cx601 placebo-matching eASCs intralesional injection Study treatments will be allocated, on a 1:1 ratio, by central randomization through interactive web response system (IWRS).
The study will follow an add-on design, participants receiving any ongoing concomitant medical treatment, at stable doses at the time of screening, for the CD will be allowed to continue it throughout the study. The primary efficacy analysis, will be conducted at Week 24 timepoint. The double blind design will be maintained up to Week 52 (both participant and investigator) by a specific blinding for study treatment administration and for evaluating its efficacy. This multicenter trial will be conducted globally across 150 centers. The overall time to participate in this study is approximately 5 years.

Arms & Interventions

Arms

Experimental: Cx601

Cx601 eASCs 120 million cells (5 million cells per milliliter [mL]) will be administered once by intralesional injection.

Placebo Comparator: Placebo

CX601 placebo-matching eASCs cells will be administered once by intralesional administration.

Interventions

Drug: - Cx601

Cx601 eASCs intralesional injection.

Other: - Placebo

Cx601 placebo-matching eASCs intralesional injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Scottsdale Mayo Clinic, Scottsdale, Arizona

Status

Not yet recruiting

Address

Scottsdale Mayo Clinic

Scottsdale, Arizona, 85259

UC San Diego Health Systems, La Jolla, California

Status

Recruiting

Address

UC San Diego Health Systems

La Jolla, California, 92037

Los Angeles, California

Status

Recruiting

Address

University of Southern California (USC) Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Inland Empire Liver Foundation, Rialto, California

Status

Recruiting

Address

Inland Empire Liver Foundation

Rialto, California, 92377

Kaiser Permamente, San Francisco, California

Status

Not yet recruiting

Address

Kaiser Permamente

San Francisco, California, 91115

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94115

Vallejo Hospital and Medical Offices, Vallejo, California

Status

Not yet recruiting

Address

Vallejo Hospital and Medical Offices

Vallejo, California, 94589

Cedar-Sinai Medical Center, West Hollywood, California

Status

Recruiting

Address

Cedar-Sinai Medical Center

West Hollywood, California, 90048

University of Colorado Hospital, Aurora, Colorado

Status

Recruiting

Address

University of Colorado Hospital

Aurora, Colorado, 80045

Hartford Hospital - Gastroenterology, Farmington, Connecticut

Status

Recruiting

Address

Hartford Hospital - Gastroenterology

Farmington, Connecticut, 06032

Yale University School of Medicine, New Haven, Connecticut

Status

Recruiting

Address

Yale University School of Medicine

New Haven, Connecticut, 06519

MedStar Georgetown University Hospital, Washington, District of Columbia

Status

Not yet recruiting

Address

MedStar Georgetown University Hospital

Washington, District of Columbia, 20017

Mayo Clinic - Gastroenterology, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic - Gastroenterology

Jacksonville, Florida, 32224

University of Miami Hospital, Miami, Florida

Status

Not yet recruiting

Address

University of Miami Hospital

Miami, Florida, 33136

Florida Hospital Orlando, Orlando, Florida

Status

Recruiting

Address

Florida Hospital Orlando

Orlando, Florida, 32804

Tampa, Florida

Status

Not yet recruiting

Address

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, 33606

Florida Hospital Tampa, Tampa, Florida

Status

Suspended

Address

Florida Hospital Tampa

Tampa, Florida, 33613

Cleveland Clinic Florida, Weston, Florida

Status

Recruiting

Address

Cleveland Clinic Florida

Weston, Florida, 33331

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

Northwestern University, Chicago, Illinois

Status

Not yet recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Rush University Medical Center, Chicago, Illinois

Status

Not yet recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612

Chicago, Illinois

Status

Recruiting

Address

The University of Chicago Medicine - Colon & Rectal Surgery

Chicago, Illinois, 60637

Carle Foundation Hospital, Urbana, Illinois

Status

Recruiting

Address

Carle Foundation Hospital

Urbana, Illinois, 61801

Indiana University - Colon and Rectal, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University - Colon and Rectal

Indianapolis, Indiana, 46237

University of Kansas Sxchool of Medicine, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Sxchool of Medicine

Kansas City, Kansas, 66160

University of Louisville, Louisville, Kentucky

Status

Recruiting

Address

University of Louisville

Louisville, Kentucky, 40292

Digestive Health Center of Louisiana, Baton Rouge, Louisiana

Status

Not yet recruiting

Address

Digestive Health Center of Louisiana

Baton Rouge, Louisiana, 70809

Colon and Rectal Surgery Associates, Metairie, Louisiana

Status

Recruiting

Address

Colon and Rectal Surgery Associates

Metairie, Louisiana, 70001

University Medical Center - New Orleans, New Orleans, Louisiana

Status

Suspended

Address

University Medical Center - New Orleans

New Orleans, Louisiana, 71103

University of Maryland, Baltimore, Maryland

Status

Recruiting

Address

University of Maryland

Baltimore, Maryland, 21201

Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins Medicine - The Johns Hopkins Hospital

Baltimore, Maryland, 21287

Massachussetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachussetts General Hospital

Boston, Massachusetts, 02114

Boston, Massachusetts

Status

Not yet recruiting

Address

Harvard Medical School-Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Lahey Hospital & Medical Center, Burlington, Massachusetts

Status

Recruiting

Address

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01803

Worcester, Massachusetts

Status

Recruiting

Address

University of Massachusetts - colon & rectal surgery

Worcester, Massachusetts, 01605

Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery

Rochester, Minnesota, 55905

Saint Louis, Missouri

Status

Recruiting

Address

Barnes-Jewish Hospital - Gastroenterology

Saint Louis, Missouri, 63110

University of Nevada School of Medicine, Las Vegas, Nevada

Status

Recruiting

Address

University of Nevada School of Medicine

Las Vegas, Nevada, 89154

Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth Hitchcock Medical Center - Cancer Center

Lebanon, New Hampshire, 03756

Boston Medical Center, Bridgewater, New Jersey

Status

Not yet recruiting

Address

Boston Medical Center

Bridgewater, New Jersey, 08807

Morristown, New Jersey

Status

Recruiting

Address

Morristown Medical Center - Gastroenterology

Morristown, New Jersey, 07960

Albany Medical Center, Albany, New York

Status

Not yet recruiting

Address

Albany Medical Center

Albany, New York, 12208

North Shore University Hospital, Manhasset, New York

Status

Recruiting

Address

North Shore University Hospital

Manhasset, New York, 11030

NYU Langone Medical Center, New York, New York

Status

Recruiting

Address

NYU Langone Medical Center

New York, New York, 10016

Stony Brook University Medical Center, New York, New York

Status

Recruiting

Address

Stony Brook University Medical Center

New York, New York, 10016

New York, New York

Status

Recruiting

Address

Weill Medical College of Cornell University

New York, New York, 10021

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10028

Columbia University Medical Center, New York, New York

Status

Not yet recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Lenox Hill Hospital, New York, New York

Status

Recruiting

Address

Lenox Hill Hospital

New York, New York, 10075

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44106

OHSU Digestive Health Center, Portland, Oregon

Status

Recruiting

Address

OHSU Digestive Health Center

Portland, Oregon, 97239-4501

Hershey, Pennsylvania

Status

Recruiting

Address

Penn State Hershey Medical Center - Surgery

Hershey, Pennsylvania, 17033

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

Allegheny General Hospital, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

Pittsburgh, Pennsylvania

Status

Not yet recruiting

Address

University of Pittsburgh Cancer Institute - UPMC CancerCente

Pittsburgh, Pennsylvania, 15213

Providence, Rhode Island

Status

Recruiting

Address

University Surgical Associates-Rhode Island Hospital

Providence, Rhode Island, 02904

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

Dallas, Texas

Status

Recruiting

Address

UT Southwestern Medical Center - Gastroenterology - Gastroenterology

Dallas, Texas, 75390

Houston, Texas

Status

Not yet recruiting

Address

Baylor College of Medicine (BCM) - Gastroenterology

Houston, Texas, 77030

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84112

University of Virginia, Charlottesville, Virginia

Status

Not yet recruiting

Address

University of Virginia

Charlottesville, Virginia, 22908

Seattle, Washington

Status

Recruiting

Address

Virginia Mason Medical Center - Gastroenterology

Seattle, Washington, 98101

Swedish Medical Center, Seattle, Washington

Status

Recruiting

Address

Swedish Medical Center

Seattle, Washington, 98104

Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology

Milwaukee, Wisconsin, 53226

International Sites

UZ Leuven - Campus Gasthuisberg, Leuven, Vlaams Brabant, Belgium

Status

Recruiting

Address

UZ Leuven - Campus Gasthuisberg

Leuven, Vlaams Brabant, 3000

AZ Delta vzw - Maag-darm-leverziekten, Roeselare, West-Vlaanderen, Belgium

Status

Recruiting

Address

AZ Delta vzw - Maag-darm-leverziekten

Roeselare, West-Vlaanderen, 8800

Antwerpen, Belgium

Status

Recruiting

Address

GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology

Antwerpen, , 2018

UZ Gent - Gastroenterology, Gent, Belgium

Status

Recruiting

Address

UZ Gent - Gastroenterology

Gent, , 9000

Clinique Saint-Joseph (CHC), Liege, Belgium

Status

Recruiting

Address

Clinique Saint-Joseph (CHC)

Liege, , 4000

University of Alberta, Edmonton, Alberta, Canada

Status

Not yet recruiting

Address

University of Alberta

Edmonton, Alberta, T6G 2X8

(G.I.R.I.) GI Research Institute, Vancouver, British Columbia, Canada

Status

Not yet recruiting

Address

(G.I.R.I.) GI Research Institute

Vancouver, British Columbia, V6Z 2K5

London, Ontario, Canada

Status

Not yet recruiting

Address

London Health Sciences Centre University Hospital

London, Ontario, N6A5A5

Ottawa Hospital, Ottawa, Ontario, Canada

Status

Not yet recruiting

Address

Ottawa Hospital

Ottawa, Ontario, K1H 8L6

Toronto, Ontario, Canada

Status

Not yet recruiting

Address

Mount Sinai Hospital - Toronto - Gastroenterology

Toronto, Ontario, M5G 1X5

NH Hospital a.s., Horovice, Beroun, Czechia

Status

Active, not recruiting

Address

NH Hospital a.s.

Horovice, Beroun, 268 31

FN Hradec Kralove, Hradec Kralove, Czechia

Status

Recruiting

Address

FN Hradec Kralove

Hradec Kralove, , 500 05

CHU de Nice, Nice Cedex 03, Alpes-Maritimes, France

Status

Recruiting

Address

CHU de Nice

Nice Cedex 03, Alpes-Maritimes, 06202

CHU de Clermont-Ferrand - Estaing, Clermont-Ferrand cedex 1, Auvergne, France

Status

Recruiting

Address

CHU de Clermont-Ferrand - Estaing

Clermont-Ferrand cedex 1, Auvergne, 63003

Hopital Beaujon, Clichy, Ile-de-France, France

Status

Active, not recruiting

Address

Hopital Beaujon

Clichy, Ile-de-France, 92110

Paris, Ile-de-France, France

Status

Recruiting

Address

Hopital Saint Louis - Gastro-hepatoenterologie

Paris, Ile-de-France, 75010

CHRU Hopital De Pontchaillou, Rennes, Ille-et-Vilaine, France

Status

Recruiting

Address

CHRU Hopital De Pontchaillou

Rennes, Ille-et-Vilaine, 35033

Vandoeuvre-les-Nancy, Lorraine, France

Status

Recruiting

Address

CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie

Vandoeuvre-les-Nancy, Lorraine, 54511

Lille, Nord, France

Status

Recruiting

Address

CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie

Lille, Nord, 59000

CHU Amiens-Picardie, AMIENS cedex 1, Picardie, France

Status

Recruiting

Address

CHU Amiens-Picardie

AMIENS cedex 1, Picardie, 80054

Centre Hospitalier Lyon Sud, Pierre-Benite, Rhone, France

Status

Recruiting

Address

Centre Hospitalier Lyon Sud

Pierre-Benite, Rhone, 69495

Paris St. Joseph Hospital, Paris, France

Status

Recruiting

Address

Paris St. Joseph Hospital

Paris, , 75014

Universitatsklinikum Erlangen, Erlangen, Bayern, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Erlangen

Erlangen, Bayern, 91054

Munchen, Bayern, Germany

Status

Not yet recruiting

Address

Klinikum der Universitat Munchen - Campus Grosshadern

Munchen, Bayern, 81377

Frankfurt/Main, Hessen, Germany

Status

Not yet recruiting

Address

Klinikum der Johann Wolfgang Goethe-Universitat

Frankfurt/Main, Hessen, 69590

Universitatsklinikum Dresden, Dresden, Sachsen, Germany

Status

Recruiting

Address

Universitatsklinikum Dresden

Dresden, Sachsen, 01307

Szeged, Csongrad, Hungary

Status

Recruiting

Address

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - I. sz. Belgyogyaszati Klinika

Szeged, Csongrad, 6720

Debreceni Egyetem Klinikai Kozpont, Debrecen, Hajdu-Bihar, Hungary

Status

Recruiting

Address

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hajdu-Bihar, H-4032

Budapest, Pest, Hungary

Status

Recruiting

Address

MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly

Budapest, Pest, 1062

Semmelweis Egyetem, Budapest, Pest, Hungary

Status

Recruiting

Address

Semmelweis Egyetem

Budapest, Pest, H-1088

Rabin Med Ctr Beilinson Hosp, Petah Tikva, HaMerkaz, Israel

Status

Recruiting

Address

Rabin Med Ctr Beilinson Hosp

Petah Tikva, HaMerkaz, 4941492

Rambam Medical Centre, Haifa, HaZafon, Israel

Status

Recruiting

Address

Rambam Medical Centre

Haifa, HaZafon, 31096

Chaim sheba Medical Center, Tel Hashomer, Tel-Aviv, Israel

Status

Recruiting

Address

Chaim sheba Medical Center

Tel Hashomer, Tel-Aviv, 5262000

Jerusalem, Yerushalayim, Israel

Status

Recruiting

Address

Shaare Zedek Medical Center - Gastroenterology

Jerusalem, Yerushalayim, 9103102

Jerusalem, Yerushalayim, Israel

Status

Recruiting

Address

Hadassah Medical Organization, Hadassah Medical Center, Ein-

Jerusalem, Yerushalayim, 91120

Ospedale Santissima Annunziata, Cento, Ferrara, Italy

Status

Recruiting

Address

Ospedale Santissima Annunziata

Cento, Ferrara, 44042

Rozzano, Milano, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center

Rozzano, Milano, 20089

Bologna, Italy

Status

Recruiting

Address

Policlinico S. Orsola Malpighi, AOU di Bologna-U.O. di Medicina Interna.

Bologna, , 40138

Modena, Italy

Status

Recruiting

Address

AOU Policlinico di Modena - Gastroenterologia

Modena, , 41124

II Universita degli Studi di Napoli, Napoli, Italy

Status

Recruiting

Address

II Universita degli Studi di Napoli

Napoli, , 80131

Gastroenterology Section, Palermo, Italy

Status

Recruiting

Address

Gastroenterology Section

Palermo, , 90127

Roma, Italy

Status

Recruiting

Address

Policlinico Universitario Campus Biomedico - UOC di Gastroenterologia

Roma, , 00128

A.O. San Camillo Forlanini, Roma, Italy

Status

Recruiting

Address

A.O. San Camillo Forlanini

Roma, , 00152

Complesso Integrato Columbus, Roma, Italy

Status

Recruiting

Address

Complesso Integrato Columbus

Roma, , 00168

Roma, Italy

Status

Recruiting

Address

Policlinico Universitario Agostino Gemelli

Roma, , 00168

Udine, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia

Udine, , 33100

Verona, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Integrata Verona (AOUI) -

Verona, , 37134

Centrum Medyczne Melita Medical, Wroclaw, Dolnoslaskie, Poland

Status

Recruiting

Address

Centrum Medyczne Melita Medical

Wroclaw, Dolnoslaskie, 50-449

Centrum Medyczne PROMED, Krakow, Malopolskie, Poland

Status

Recruiting

Address

Centrum Medyczne PROMED

Krakow, Malopolskie, 31-411

Wielospecjalistyczny Szpital Medicover, Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

Wielospecjalistyczny Szpital Medicover

Warszawa, Mazowieckie, 03-984

Endoskopia Sp z o.o., Sopot, Pomorskie, Poland

Status

Recruiting

Address

Endoskopia Sp z o.o.

Sopot, Pomorskie, 81-756

San Juan, Puerto Rico

Status

Recruiting

Address

University of Puerto Rico School of Medicine

San Juan, , 00936

Hospital Universitario Son Espases, Palma de Mallorca, Baleares, Spain

Status

Recruiting

Address

Hospital Universitario Son Espases

Palma de Mallorca, Baleares, 07120

Corporacio Sanitaria Parc Tauli, Sabadell, Barcelona, Spain

Status

Recruiting

Address

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 8208

Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942

Majadahonda, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222

Hospital de Sagunto, Sagunto, Valencia, Spain

Status

Recruiting

Address

Hospital de Sagunto

Sagunto, Valencia, 46520

Hospital Clinic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona

Barcelona, , 08036

Hospital del Mar, Barcelona, Spain

Status

Recruiting

Address

Hospital del Mar

Barcelona, , 8003

Hospital Universitario Ramon y Cajal, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Ramon y Cajal

Madrid, , 28034

Hospital Clinico San Carlos, Madrid, Spain

Status

Recruiting

Address

Hospital Clinico San Carlos

Madrid, , 28040

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , 28040

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, , 28041

Hospital Universitario La Paz, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario La Paz

Madrid, , 28046

C.H.U. de Pontevedra, Pontevedra, Spain

Status

Recruiting

Address

C.H.U. de Pontevedra

Pontevedra, , 36071

H.U.V. del Rocio, Sevilla, Spain

Status

Recruiting

Address

H.U.V. del Rocio

Sevilla, , 21005

Glasgow, Glasgow City, United Kingdom

Status

Not yet recruiting

Address

NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary (GRI)

Glasgow, Glasgow City, G52 3NQ

Guys & St Thomas, London, London, City Of, United Kingdom

Status

Not yet recruiting

Address

Guys & St Thomas

London, London, City Of, SE1 7EH

Nottingham, Nottinghamshire, United Kingdom

Status

Not yet recruiting

Address

Nottingham University Hospitals NHS Trust - Surgery

Nottingham, Nottinghamshire, NG7 2UH

Addenbrooke's Hospital, Cambridge, United Kingdom

Status

Not yet recruiting

Address

Addenbrooke's Hospital

Cambridge, , CB2 0QQ

Glasgow, United Kingdom

Status

Not yet recruiting

Address

NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary (GRI)

Glasgow, , G4 0SF

Guys & St Thomas, London, United Kingdom

Status

Not yet recruiting

Address

Guys & St Thomas

London, , SE1 7EH

Wythenshawe Hospital - Gastroenterology, Manchester, United Kingdom

Status

Not yet recruiting

Address

Wythenshawe Hospital - Gastroenterology

Manchester, , M13 9WL

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