granulomatous enteritis Inflammatory bowel disease
Conditions
Interventions
None listed
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18 and 65 years 2) Confirmed diagnosis of active Crohn*s Disease: 3) Active disease at the time of registration to the trial 4) Unsatisfactory course despite 3 immunosuppressive agents (usually azathioprine, methotrexate and infliximab or adalimumab) in addition to corticosteroids. Patients should have relapsing disease (i.e. >1 exacerbation/year) despite thiopurines, methotrexate and/or infliximab/adalimumab maintenance therapy or clear demonstration of intolerance / toxicity to these drugs. 4) Current problems unsuitable for surgery or patient is at risk for developing short bowel syndrome.
Exclusion criteria
Exclusion criteria: 1) Pregnancy or unwillingness to use adequate contraception during the treatement, if a woman of childbearing age 2) Concomitant severe disease a) renal: creatinine clearance = 140 and/or resting diastolic pressure >= 90 despite at least 2 anti-hypertensive agents. f) uncontrolled acute or chronic infection with HIV, HTLV-1 or 2, hepatitis viruses or any other infection the investigators consider a contraindication to participation. g) other chronic disease causing significant organ failure, including established cirrhosis with evidence of impaired synthetic function on biochemical testing and known severe respiratory disease. h) Crohn*s Disease symptoms predominantly due to fibrotic stricturing and unlikely to respond to immune manipulation. 3) Infection or risk thereof a) History of tuberculosis or at current increased risk of tuberculosis b) Mantoux test result or other investigations that the investigator as evidence of active tuberculosis. c) Abnormal chest x ray (CXR) consistent with active infection or neoplasm. 4) Previous poor compliance 5) Concurrent enrolment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate on the cost effectivity and the immunological mechanisms involved in immune reconstitution and engraftment after ASCT in Crohn's disease patients. To gain insight in the effect of ASCT on the microbiome | — |
Countries
Netherlands
Outcome results
None listed