ASTIC Autologous Stem Cell Transplantation for Crohn's Disease

Inclusion Criteria

• •1. Age between 18 and 50 years (Patients aged 50-65 can participate if specially approved by the Trial Steering Committee)
• •2. Confirmed diagnosis of active Crohn's Disease
• •3. Unsatisfactory course despite 3 immunosuppressive agents (usually azathioprine, methotrexate and infliximab) in addition to corticosteroids. Patients should have relapsing disease (i.e. \>1 exacerbation/year) despite thiopurines, methotrexate and/or infliximab maintenance therapy or clear demonstration of intolerance / toxicity to these drugs.
• •4. Impaired function and quality of life, compared to population means, on at least one of the following:
• •1. IBDQ (Appendix 6)
• •2. European Questionnaire of Life quality (EuroQOL-5D, Appendix 4)
• •3. Impaired function on Karnofsky index (Appendix 7)
• •5. Current problems unsuitable for surgery and patient at risk for developing short bowel syndrome.
• •6. Informed consent
• •1. Wherever possible, diseased tissue should be accessible endoscopically for objective histological study but in the case of small bowel disease that is extensive but does not extend to duodenum or terminal ileum, participation without endoscopy is allowed.
• •2. Smokers may enter the study provided they have received intensive counselling about smoking.
• •3. Add patients with ileostomy/colostomy and patients with short bowel syndrome