Autologous Stem Cell Transplantation for Crohn?s Disease: Autologous Stem Cell Transplantation International Crohn?s Disease Trial A multicentre, prospective, randomised phase III study conducted by the European Crohn?s and Colitis Organisation (ECCO), sponsored by the Autoimmune Disease Working Party of the European Group for Blood and Marrow Transplantation (EBMT) - ASTIC

Conditions: Crohn`s disease
MedDRA version: 9.1Level: LLTClassification code 10013099Term: Disease Crohns

Registration Number: EUCTR2005-003337-40-IT

Lead Sponsor: WOLFSON DIGESTIVE DISEASES CENTRE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 48

Inclusion Criteria

1)Age between 18 and 50 years a)Patients aged 50-65 can participate if specially approved by the Trial Steering Committee 2)Confirmed diagnosis of active Crohn?s Disease: a)Diagnosis of Crohn?s disease based on typical radiological appearances and / or typical histology b)Active disease at the time of registration to the trial, defined as i)Crohn?s disease activity index (CDAI) > 250 and > 2 of the following: ii)raised CRP, iii)endoscopic evidence of active disease confirmed on histology iv)clear evidence of active small bowel Crohn?s disease on small bowel barium study. 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: a)IBDQ (Appendix 6) b)European Questionnaire of Lifequality (EuroQOL?5D, Appendix 4) c)SF-36 Appendix 5) d)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 (Sample Information Sheet and Consent Form given in Appendices 1 and 2 respectively) a)Prepared to enter controlled study. b)Prepared to undergo additional study procedures as per trial schedule c)Patient has undergone intensive counselling about risks d)Consent to future genotyping assessments is optional, but is not required for the patient to enter the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Pregnancy or unwillingness to use adequate contraception during the study, if a woman of childbearing age 2)Concomitant severe disease a)renal: creatinine clearance < 40 ml/min (measured or estimated) b)cardiac: clinical evidence of refractory congestive heart failure; left ventricular ejection fraction < 45% by multigated radionuclide angiography (MUGA) or cardiac echo; chronic atrial fibrillation necessitating oral anticoagulation; uncontrolled ventricular arrhythmia; pericardial effusion with hemodynamic consequences as evaluated by an experienced echocardiographer c)psychiatric disorders including active drug or alcohol abuse d)concurrent neoplasms or myelodysplasia e)bone marrow insufficiency defined as leucocytopenia <3.0 x 10E9/l, thrombocytopenia <50 x 10E9/l, anemia < 8 g/dl, CD4+ T lymphopenia < 200 x 10E6/l f)uncontrolled hypertension, defined as resting systolic blood pressure ≥ 140ml and/or resting diastolic pressure ≥ 90ml mercury despite at least 2 anti-hypertensive agents. g)Uncontrolled acute or chronic infection with HIV, HTLV ? 1 or 2, hepatitis viruses or any other infection the investigator or Steering Committee consider a contraindication to participation. h)Other chronic disease causing significant organ failure, including established cirrhosis with evidence of impaired synthetic function on biochemical testing and known respiratory disease causing resting arterial oxygen tension <8 kpa or carbon dioxide tension >6.7 kpa. Patients not known to have respiratory disease need not have blood gas measurements. i)Crohn?s Disease symptoms predominantly due to fibrotic stricturing and unlikely to respond to immune manipulation, in the opinion of any of the investigators or the steering committee 3)Diarrhoea due to short small or large bowel a)Patients believed to have <= 700 mm of small bowel or <= 300 mm of large bowel following ileo-rectal anastamosis and diarrhoea attributable to this, making assessment of Crohn?s disease activity index invalid should not enter the study 4)Infection or risk thereof a)Current abscess or significant active infection. b)Perianal sepsis is not an exclusion provided there is natural free drainage or a Seton suture(s) have been placed. c)History of tuberculosis or at current increased risk of tuberculosis d)Mantoux test result or other investigations that the investigator or Steering Committee regard as evidence of active tuberculosis. e)Abnormal chest x ray (CXR) consistent with active infection or neoplasm. 5)Significant malnutrition: Body Mass Index (BMI) ≤ 18, serum albumin <=20 g/l 6)Previous poor compliance 7)Concurrent enrolment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry. 8)Lack of funding