Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease

Summary

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 anal fistulas in patients with Crohn's disease over a 24-week period and an extended follow-up period up to 104 weeks.

Conditions

• Crohn's Disease

Interventions

OTHER

Cx601

120 million cells administered by intralesional injection.

OTHER

Saline solution

24 mL saline solution by intralesional injection

Sponsors & Collaborators

• Tigenix S.A.U.

  lead INDUSTRY

Principal Investigators

• Julian Panes, MD · Hospital Clinic of Barcelona

• Julian Panes, MD · Hospital Clinic of Barcelona

• Lili Kazemi-Shirazi, Professor · Medical University of Vienna

• Karl Mrak, MD · Krankenhaus, St. Veit/Glan

• Marc Ferrante, MD · Universitaire Ziekenhuizen KU Leuven

• Kurt Van der Speeten, MD · Hospital Oost-Limburg, Genk

• Danny de Looze, Professor · Gent University Hospital

• Filip Baert, MD · Hospital Hartziekenhuis, Roeselare

• Daniel C Baumgart, Professor · Charite University, Berlin, Germany

• Axel Dignass, Professor · Kilikum Frankfurt

• Max Reinshagen, Professor · Kinikum Braunschweig

• Silvio Danese, MD · Instituto Clinico Humanitas IRCCS, Milano

• Vito Annese, MD · Azienda Ospedaliero-Universitaria Careggi

• Anna Kohn, MD · Azienda Ospedaliera San Camillo-Forlanini, Rome

• Alfredo Papa, MD · Università Cattolica del Sacro Cuore, Rome

• Giacomo C Sturniolo, Professor · Azienda Ospedaliera di Padova

• Andrea Belluzi, MD · Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola Malpighi

• Gabriele Riegler, Professor · University of Campania Luigi Vanvitelli

• Bas Oldenburg, MD · UMCU, Utrecht

• Adriaan A van Bodegraven, MD · Amsterdam UMC, location VUmc

• Gigs van den Brink, Professor · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• María D Martín Arranz, MD · Hospital Universitario La Paz

• Jose M Gallardo Valverde, MD · Hospital Universitario Reina Sofía, Cordoba

• Javier Pérez Gisbert, MD · Hospital La Princesa, Madrid

• Belén Beltrán Niclós, MD · Hospital Universitario La Fe

• Carlos Taxonera Samsó, MD · Hospital Clínico San Carlos, Madrid

• Fernando de la Portilla de Juan, MD · Hospital Virgen del Rocío, Seville

• Ricardo Rada Morgades, MD · Hospital Juan Ramón Jiménez, Huelva

• Gonzalo Gómez Gómez, MD · Hospital Universitario 12 de Octubre, Madrid

• Daniel Carpio López, MD · Hospital de Montecelo, Pontevedra

• Xavier Cortés Rizo, MD · Hospital de Sagunto, Valencia

• Torsten Kucharzik, Professor · Klinikum Lüneburg

• Andreas Sturm, Professor · Krakenhaus Walfriede, Berlin

• Antonio López Sanromán, MD · Hospital Universitario Ramon y Cajal

• Joaquín Hinojosa de Val, MD · Hospital de Manises, Valencia

• Xavier González Argenté, MD · Son Espases, Palma de Mallorca

• Maria Nachury, MD · CHRU de Lille

• Frank Zerbib, MD · University Hospital, Bordeaux

• Stéphanie Viennot, MD · University Hospital, Caen

• Jean-Louis Dupas, MD · Centre Hospitalier Universitaire, Amiens

• Jean-Charles Grimaud, MD · CHU de Marseille

• Xavier Hebuterne, Professor · Centre Hospitalier Universitaire de Nice

• Matthieu Allez, Professor · Hôpital Saint Louis Paris

• Yoram Bouhnik, MD · Hôpital Beaujon, Clichy

• Matti Waterman, MD · Rambam MC, Haifa

• Shomron Ben-Horin, MD · Sheba MC, Tel Hashomer

• Sigal Fishman, MD · Tel Aviv Sourasky MC, Tel Aviv

• Eran Goldin, Professor · Sharee Zedek MC, Jerusalem

• Irit Avni-Biron, MD · Rabin MC, Petah Tikva

• Herbert Tilg, Professor · Univ.-Klinik Innsbruck

• Lennard Gilissen, MD · Catharina Ziekenhuis Eindhoven

• Carlos Pastor, MD · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

• Wolfgang Kruis, Professor · Evangelisches Krankenhaus Kalk, Köln

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2015-07-31

Completion

2016-11-30

Countries

• Austria
• Belgium
• France
• Germany
• Israel
• Italy
• Netherlands
• Spain

Study Locations