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)

PHASE3CompletedINTERVENTIONAL
Enrollment

568

Participants

Timeline

Start Date

September 15, 2017

Primary Completion Date

January 23, 2023

Study Completion Date

July 26, 2023

Conditions
Crohn's Disease
Interventions
DRUG

Cx601

Cx601 eASCs intralesional injection.

OTHER

Placebo

Cx601 placebo-matching eASCs intralesional injection.

Trial Locations (159)

1062

MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly, Budapest

2018

GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology, Antwerp

2400

Bispebjerg Hospital, Copenhagen

2820

Imelda Ziekenhuis, Antwerp

3000

UZ Leuven - Campus Gasthuisberg, Leuven

4000

CHU de Liege - Domaine Universitaire du Sart Tilman, Liège

Clinique Saint-Joseph (CHC), Liège

5530

CHU Dinant Godinne UCL Namur, Namur

6720

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

8003

Hospital del Mar, Barcelona

8200

Aarhus University Hospital - Department of Hepatology and Gastroenterology, Lever-Mave- og Tarmsygdomme Klinik, krydspunkt C216, Aarhus

8208

Corporacio Sanitaria Parc Tauli, Sabadell

8500

AZ Groeninge - Campus Kennedylaan - Gastro-enterology, Kortrijk

8800

AZ Delta vzw - Maag-darm-leverziekten, Roeselare

9000

UZ Gent - Gastroenterology, Ghent

10016

NYU Langone Medical Center, New York

Stony Brook University Medical Center, New York

10021

Weill Medical College of Cornell University, New York

10028

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Medical Center, New York

10075

Lenox Hill Hospital, New York

11030

North Shore University Hospital - Gastroenterology, Manhasset

12208

Albany Medical Center, Albany

15212

Allegheny General Hospital, Pittsburgh

17033

Harvard Medical School-Beth Israel Deaconess Medical Center, Hershey

Penn State Hershey Medical Center - Surgery, Hershey

19107

Thomas Jefferson University Hospital, Philadelphia

20017

MedStar Georgetown University Hospital, Washington D.C.

20089

Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center, Rozzano

21005

H.U.V. del Rocio, Seville

21201

University of Maryland, Baltimore

21287

Johns Hopkins Medicine - The Johns Hopkins Hospital, Baltimore

22908

University of Virginia, Charlottesville

24016

Carilion Clinic, Roanoke

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

29425

Medical University of South Carolina, Charleston

30322

Emory University, Atlanta

31059

Centre Hospitalier Universitaire De Toulouse - Hopital De Ra, Toulouse

31096

Rambam Medical Centre, Haifa

32224

Mayo Clinic - Gastroenterology, Jacksonville

32804

Florida Hospital Orlando, Orlando

33100

Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia, Udine

33136

University of Miami Hospital, Miami

33331

Cleveland Clinic Florida, Weston

33606

USF Health South Tampa Center for Advanced Healthcare, Tampa

33613

Florida Hospital Tampa, Tampa

35033

CHRU Hopital De Pontchaillou, Rennes

36071

C.H.U. de Pontevedra, Pontevedra

37134

Azienda Ospedaliera Universitaria Integrata Verona (AOUI) -, Verona

37232

Vanderbilt University Medical Center, Nashville

40138

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

40292

University of Louisville, Louisville

41124

AOU Policlinico di Modena - Gastroenterologia, Modena

42270

CHU Saint Etienne, Saint Priest En Jarez

44042

Ospedale Santissima Annunziata, Cento

44106

Cleveland Clinic, Cleveland

46237

Indiana University - Colon and Rectal, Indianapolis

46520

Hospital de Sagunto, Sagunto

53215

Aurora St. Luke's Medical Center, Milwaukee

53226

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

54511

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

55905

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

56126

Universita degli studi di Pisa, Pisa

57701

Rapid City Medical Center, Rapid City

59000

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

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

60637

The University of Chicago Medicine - Colon & Rectal Surgery, Chicago

61801

Carle Foundation Hospital, Urbana

63003

CHU de Clermont-Ferrand - Estaing, Clermont-Ferrand

63110

Barnes-Jewish Hospital - Gastroenterology, St Louis

66160

University of Kansas Sxchool of Medicine, Kansas City

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

69590

Klinikum der Johann Wolfgang Goethe-Universitat, Frankfurt am Main

70001

Colon and Rectal Surgery Associates, Metairie

70809

Digestive Health Center of Louisiana, Baton Rouge

71103

University Medical Center - New Orleans, New Orleans

75010

Hopital Saint Louis - Gastro-hepatoenterologie, Paris

75014

Paris St. Joseph Hospital, Paris

75390

UT Southwestern Medical Center - Gastroenterology - Gastroenterology, Dallas

77030

Baylor College of Medicine (BCM) - Gastroenterology, Houston

80045

University of Colorado Hospital, Aurora

80054

CHU Amiens-Picardie, Amiens

80131

II Universita degli Studi di Napoli, Napoli

81377

Klinikum der Universitat Munchen - Campus Grosshadern, München

84112

University of Utah, Salt Lake City

85259

Scottsdale Mayo Clinic, Scottsdale

89154

University of Nevada School of Medicine, Las Vegas

90033

University of Southern California (USC) Norris Comprehensive Cancer Center, Los Angeles

90048

Cedar-Sinai Medical Center, West Hollywood

90127

Gastroenterology Section, Palermo

91054

Universitatsklinikum Erlangen, Erlangen

91115

Kaiser Permamente, San Francisco

91120

Hadassah Medical Organization, Hadassah Medical Center, Ein-, Jerusalem

92037

UC San Diego Health Systems, La Jolla

92110

Hopital Beaujon, Clichy

92377

Inland Empire Liver Foundation, Rialto

92868

UC Irvine Medical Center - Chao Family Comprehensive Cancer, Orange

94115

University of California San Francisco, San Francisco

94589

Vallejo Hospital and Medical Offices, Vallejo

97239

OHSU Digestive Health Center, Portland

98101

Virginia Mason Medical Center - Gastroenterology, Seattle

98104

Swedish Medical Center, Seattle

4941492

Rabin Med Ctr Beilinson Hosp, Petah Tikva

5262000

Chaim sheba Medical Center, Tel Litwinsky

9103102

Shaare Zedek Medical Center - Gastroenterology, Jerusalem

06032

Hartford Hospital - Gastroenterology, Farmington

06519

Yale University School of Medicine, New Haven

02114

Massachussetts General Hospital, Boston

08807

Boston Medical Center, Boston

01803

Lahey Hospital & Medical Center, Burlington

01605

University of Massachusetts - colon & rectal surgery, Worcester

03756

Dartmouth Hitchcock Medical Center - Cancer Center, Lebanon

07960

Morristown Medical Center - Gastroenterology, Morristown

02904

University Surgical Associates-Rhode Island Hospital, Providence

T6G 2X8

University of Alberta, Edmonton

V6Z 2K5

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

K1H 8L6

Ottawa Hospital, Ottawa

M5G 1X5

Mount Sinai Hospital - Toronto - Gastroenterology, Toronto

M5T 3A9

Kensington Screening Clinic - Gastroenterology, Toronto

H2X 3J4

Centre Hospitalier de l'Universite de Montreal, Montreal

H3G 1A4

McGill University Health Centre - Montreal General Hospital, Montreal

268 31

NH Hospital a.s., Hořovice

500 05

FN Hradec Kralove, Hradec Králové

Unknown

Odense Universitetshospital, Odense

06202

CHU de Nice, Nice

01307

Universitatsklinikum Dresden, Dresden

H-4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

H-1088

Semmelweis Egyetem, Budapest

00128

Policlinico Universitario Campus Biomedico - UOC di Gastroenterologia, Roma

00152

A.O. San Camillo Forlanini, Roma

00168

Complesso Integrato Columbus, Roma

Policlinico Universitario Agostino Gemelli, Roma

31-411

Centrum Medyczne PROMED, Krakow

50-449

Centrum Medyczne Melita Medical, Wroclaw

03-984

Wielospecjalistyczny Szpital Medicover, Warsaw

81-756

Endoskopia Sp z o.o., Sopot

80-803

COPERNICUS Podmiot Leczniczy Sp. z o.o., Gdansk

02-507

Centralny Szpital Kliniczny MSWiA w Warszawie, Warsaw

90-647

Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow, Lodz

00936

University of Puerto Rico School of Medicine, San Juan

07120

Hospital Universitario Son Espases, Palma de Mallorca

08916

H.U. G.Trias i Pujol, Badalona

08036

Hospital Clinic de Barcelona, Barcelona

581 85

Linkoping University Hospital - Department of Surgery, Linköping

CB2 0QQ

Addenbrooke's Hospital, Cambridge

G52 3NQ

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

HA1 3UJ

St. Mark's Hospital, Harrow

SE1 7EH

Guys & St Thomas, London

NG7 2UH

Nottingham University Hospitals NHS Trust - Surgery, Nottingham

NW1 2BU

University Colleague London Hospital (UCLH), London

M13 9WL

Wythenshawe Hospital - Gastroenterology, Manchester

S10 2JF

Northern General Hospital, Sheffield

All Listed Sponsors
lead

Tigenix S.A.U.

INDUSTRY

NCT03279081 - 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) | Biotech Hunter | Biotech Hunter