Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance or toxicity to conventional treatment. The purpose of this study is to determine whether there is a potential clinical benefit of hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice.
Open label, phase III, randomised, multicentre study comparing early transplantation procedure with transplantation carried out to the same protocol but delayed by one year. The status of patients undergoing early HSCT will be evaluated after one year and compared to those about to undergo delayed HSCT Patients will be randomised to: * Hematopoietic stem cell mobilisation followed, within 4 weeks, by high dose immunoablation and autologous stem cell transplantation * Hematopoietic stem cell mobilisation followed, after 59 weeks, by high dose immunoablation and autologous hematopoietic stem cell transplantation All patients will be mobilised prior to randomisation. Those receiving early transplantation will be compared over the first year with those whose transplant has been delayed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
All patients will be mobilised prior to randomisation. Those receiving early transplantation will be compared over the first year with those whose transplant has been delayed.
University Hospital Gasthuisberg
Leuven, Herestraat 49, Belgium
University of Calgery
Calgary, Alberta, Canada
Proportion patients in sustained disease remission
To evaluate the potential clinical benefit of hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice in patients with Crohn' s disease.
Time frame: 1 year
patients who have not responded to immunosuppressant medication
To evaluate the safety of Hematopoietic Stem Cell Transplantation (HSCT) in Crohn's disease patients who have not responded to immunosuppressant medication
Time frame: 1 - 2 years
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Hopital Huriez Chru
Lille, France
Hospital Sanin-Louis
Paris, France
Dipatimento di Medicina Interna E Gastroenterologia
Bologna, Italy
Universita di Bologna Interna e Gastroenterologia Policlinico Saint Orsola
Bologna, Italy
Careggi Hospital
Florence, Italy
Istituto Clinico Humanitas
Milan, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milan, Italy
L Sacco University Hopsital
Milan, Italy
...and 9 more locations