NL-OMON39547招募中不适用
Autologous stem cell transplantation for the treatment of refractory Crohn*s disease: mechanisms of succes - Mechanisms of succes of ASCT for Crohn's disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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 < 40 ml/min (measured or estimated)
- •b) cardiac: clinical evidence of refractory congestive heart failure
- •c) psychiatric disorders including active drug or alcohol abuse
- •d) concurrent or recent history of malignant disease (excl. non-melanoma skin cancer)
- •e) uncontrolled hypertension, defined as resting systolic blood pressure >= 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.
研究者
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