Stem Cell Transplantation in Crohn's Disease

Inclusion Criteria:

1. Aged 13-28 years are eligible

2. Confirmed diagnosis of active Crohn's disease:

3. Diagnosis of Crohn's disease based on typical radiological appearances and / ortypical histology at least 6 months prior to screening.

4. Active disease at the time of registration to the trial, defined as i) PCDAI > 30, and ii) Two of the following:

5. elevated CRP

6. endoscopic evidence of active disease confirmed by histology

7. clear evidence of active small bowel Crohn's disease on CT or MR enterography.

8. Unsatisfactory course despite 3 immunosuppressive agents (usually azathioprine,methotrexate and infliximab, adalimumab and/or certolizumab) in addition tocorticosteroids. Patients should have relapsing disease (i.e. 1 exacerbation/year)despite thiopurines, methotrexate and/or infliximab/adalimumab/certolizumabmaintenance therapy or clear demonstration of intolerance / toxicity to these drugs.

9. Current problems unsuitable for surgery or patient at risk for developing shortbowel syndrome.

10. Accepted by a majority of the members of the combined IBD Center as an appropriatecandidate (see Selection description below).

11. Informed consent

12. Prepared to undergo additional study procedures as per trial schedule

13. Patient has undergone intensive counseling about risks

Exclusion Criteria:

1. Pregnancy or unwillingness to use adequate contraception during the study, in womenof childbearing age. Unwillingness of using appropriate contraceptive measures inmales.

2. Concomitant severe disease

3. renal: creatinine clearance < 30 mL/min (measured or estimated)

4. cardiac: clinical evidence of refractory congestive heart failure; leftventricular ejection fraction < 40% by cardiac echo; chronic atrialfibrillation necessitating oral anticoagulation; uncontrolled ventriculararrhythmia; pericardial effusion with hemodynamic consequences as evaluated byan experienced echo cardiographer

5. pulmonary: diffusion capacity <40%

6. psychiatric disorders including active drug or alcohol abuse

7. concurrent or recent history of malignant disease (excluding non-melanoma skincancer)

8. uncontrolled hypertension, defined as resting systolic blood pressure ≥ 140and/or resting diastolic pressure ≥ 90 despite at least 2 anti-hypertensiveagents.

9. any infection with HIV, HTLV-1 or 2, hepatitis viruses, or any other infectionthe investigators consider a contraindication to participation.

10. other chronic disease causing significant organ failure.

11. Infection or risk thereof:

12. Current clinical relevant abscess or significant active infection.

13. Perianal fistula without free drainage. Perianal fistulas is not an exclusionprovided there is natural free drainage or a seton suture(s) have been placed.

14. History of tuberculosis or at current increased risk of tuberculosis

15. Quantiferon Gold test result or other investigations that the investigatorsregard as evidence of active tuberculosis.

16. Abnormal chest X-ray (CXR) consistent with active infection or neoplasm.

6. Significant malnutrition: Body Mass Index (BMI) ≤ 18, serum albumin < 20 g/l.

7. Previous poor compliance. 8) Concurrent enrollment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry.