Stem Cell Transplantation in Crohn's Disease

Lab values

• Concomitant severe disease
  • renal: creatinine clearance \< 30 mL/min (measured or estimated)
  • 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
  • pulmonary: diffusion capacity \<40%
  • psychiatric disorders including active drug or alcohol abuse
  • concurrent or recent history of malignant disease (excluding non-melanoma skin cancer)
  • uncontrolled hypertension, defined as resting systolic blood pressure ≥ 140 and/or resting diastolic pressure ≥ 90 despite at least 2 anti-hypertensive agents.
  • any infection with HIV, HTLV-1 or 2, hepatitis viruses, or any other infection the investigators consider a contraindication to participation.
  • other chronic disease causing significant organ failure.
• Infection or risk thereof:
  • Current clinical relevant abscess or significant active infection.
  • 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.
  • History of tuberculosis or at current increased risk of tuberculosis
  • Quantiferon Gold test result or other investigations that the investigators regard as evidence of active tuberculosis.
  • 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.

Age

• Pregnancy or unwillingness to use adequate contraception during the study, in women of childbearing age. Unwillingness of using appropriate contraceptive measures in males.

• Aged 13-28 years are eligible
• Confirmed diagnosis of active Crohn's disease:
  • Diagnosis of Crohn's disease based on typical radiological appearances and / or typical histology at least 6 months prior to screening.
  • Active disease at the time of registration to the trial, defined as
  • PCDAI \> 30, and ii) Two of the following:
  • elevated CRP
  • endoscopic evidence of active disease confirmed by histology
  • clear evidence of active small bowel Crohn's disease on CT or MR enterography.
• 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.
• Current problems unsuitable for surgery or patient at risk for developing short bowel syndrome.
• Accepted by a majority of the members of the combined IBD Center as an appropriate candidate (see Selection description below).
• Informed consent
  • Prepared to undergo additional study procedures as per trial schedule
  • Patient has undergone intensive counseling about risks