Stem Cell Transplantation in Crohn's Disease

Eligibility Criteria

• 1. Aged 13-28 years are eligible
• 2. Confirmed diagnosis of active Crohn's disease:
• 1. Diagnosis of Crohn's disease based on typical radiological appearances and / or typical histology at least 6 months prior to screening.
• 2. Active disease at the time of registration to the trial, defined as
• 1. elevated CRP
• 2. endoscopic evidence of active disease confirmed by histology
• 3. clear evidence of active small bowel Crohn's disease on CT or MR enterography.
• 3. Unsatisfactory course despite 3 immunosuppressive agents (usually azathioprine, methotrexate and infliximab, adalimumab and/or certolizumab) in addition to corticosteroids. Patients should have relapsing disease (i.e. 1 exacerbation/year) despite thiopurines, methotrexate and/or infliximab/adalimumab/certolizumab maintenance therapy or clear demonstration of intolerance / toxicity to these drugs.
• 4. Current problems unsuitable for surgery or patient at risk for developing short bowel syndrome.
• 5. Accepted by a majority of the members of the combined IBD Center as an appropriate candidate (see Selection description below).
• 6. Informed consent
• 1. Prepared to undergo additional study procedures as per trial schedule
• 2. Patient has undergone intensive counseling about risks
• 1. Pregnancy or unwillingness to use adequate contraception during the study, in women of childbearing age. Unwillingness of using appropriate contraceptive measures in males.
• 2. Concomitant severe disease
• 1. renal: creatinine clearance \< 30 mL/min (measured or estimated)
• 2. cardiac: clinical evidence of refractory congestive heart failure; left ventricular ejection fraction \< 40% by cardiac echo; chronic atrial fibrillation necessitating oral anticoagulation; uncontrolled ventricular arrhythmia; pericardial effusion with hemodynamic consequences as evaluated by an experienced echo cardiographer
• 3. pulmonary: diffusion capacity \<40%
• 4. psychiatric disorders including active drug or alcohol abuse
• 5. concurrent or recent history of malignant disease (excluding non-melanoma skin cancer)
• 6. uncontrolled hypertension, defined as resting systolic blood pressure ≥ 140 and/or resting diastolic pressure ≥ 90 despite at least 2 anti-hypertensive agents.
• 7. any infection with HIV, HTLV-1 or 2, hepatitis viruses, or any other infection the investigators consider a contraindication to participation.
• 8. other chronic disease causing significant organ failure.
• 3. Infection or risk thereof:
• 1. Current clinical relevant abscess or significant active infection.
• 2. Perianal fistula without free drainage. Perianal fistulas is not an exclusion provided there is natural free drainage or a seton suture(s) have been placed.
• 3. History of tuberculosis or at current increased risk of tuberculosis
• 4. Quantiferon Gold test result or other investigations that the investigators regard as evidence of active tuberculosis.
• 5. Abnormal chest X-ray (CXR) consistent with active infection or neoplasm.