EUCTR2005-003337-40-IT进行中（未招募）不适用
Autologous Stem Cell Transplantation for Crohn?s Disease: Autologous Stem Cell Transplantation International Crohn?s Disease Trial A multicentre, prospective, randomised phase III study conducted by the European Crohn?s and Colitis Organisation (ECCO), sponsored by the Autoimmune Disease Working Party of the European Group for Blood and Marrow Transplantation (EBMT) - ASTIC
WOLFSON DIGESTIVE DISEASES CENTRE0 个研究点目标入组 48 人开始时间: 2008年12月30日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Age between 18 and 50 years a)Patients aged 50-65 can participate if specially approved by the Trial Steering Committee 2)Confirmed diagnosis of active Crohn?s Disease: a)Diagnosis of Crohn?s disease based on typical radiological appearances and / or typical histology b)Active disease at the time of registration to the trial, defined as i)Crohn?s disease activity index (CDAI) > 250 and > 2 of the following: ii)raised CRP, iii)endoscopic evidence of active disease confirmed on histology iv)clear evidence of active small bowel Crohn?s disease on small bowel barium study. 3)Unsatisfactory course despite 3 immunosuppressive agents (usually azathioprine, methotrexate and infliximab) in addition to corticosteroids. Patients should have relapsing disease (i.e.  1 exacerbation/year) despite thiopurines, methotrexate and/or infliximab maintenance therapy or clear demonstration of intolerance / toxicity to these drugs. 4)Impaired function and quality of life, compared to population means, on at least one of the following: a)IBDQ (Appendix 6) b)European Questionnaire of Lifequality (EuroQOL?5D, Appendix 4) c)SF-36 Appendix 5) d)Impaired function on Karnofsky index (Appendix 7) 5)Current problems unsuitable for surgery and patient at risk for developing short bowel syndrome. 6)Informed consent (Sample Information Sheet and Consent Form given in Appendices 1 and 2 respectively) a)Prepared to enter controlled study. b)Prepared to undergo additional study procedures as per trial schedule c)Patient has undergone intensive counselling about risks d)Consent to future genotyping assessments is optional, but is not required for the patient to enter the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Pregnancy or unwillingness to use adequate contraception during the study, 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; left ventricular ejection fraction < 45% by multigated radionuclide angiography (MUGA) or cardiac echo; chronic atrial fibrillation necessitating oral anticoagulation; uncontrolled ventricular arrhythmia; pericardial effusion with hemodynamic consequences as evaluated by an experienced echocardiographer c)psychiatric disorders including active drug or alcohol abuse d)concurrent neoplasms or myelodysplasia e)bone marrow insufficiency defined as leucocytopenia <3.0 x 10E9/l, thrombocytopenia <50 x 10E9/l, anemia < 8 g/dl, CD4+ T lymphopenia < 200 x 10E6/l f)uncontrolled hypertension, defined as resting systolic blood pressure ≥ 140ml and/or resting diastolic pressure ≥ 90ml mercury despite at least 2 anti-hypertensive agents. g)Uncontrolled acute or chronic infection with HIV, HTLV ? 1 or 2, hepatitis viruses or any other infection the investigator or Steering Committee consider a contraindication to participation. h)Other chronic disease causing significant organ failure, including established cirrhosis with evidence of impaired synthetic function on biochemical testing and known respiratory disease causing resting arterial oxygen tension <8 kpa or carbon dioxide tension >6.7 kpa. Patients not known to have respiratory disease need not have blood gas measurements. i)Crohn?s Disease symptoms predominantly due to fibrotic stricturing and unlikely to respond to immune manipulation, in the opinion of any of the investigators or the steering committee 3)Diarrhoea due to short small or large bowel a)Patients believed to have <= 700 mm of small bowel or <= 300 mm of large bowel following ileo-rectal anastamosis and diarrhoea attributable to this, making assessment of Crohn?s disease activity index invalid should not enter the study 4)Infection or risk thereof a)Current abscess or significant active infection. b)Perianal sepsis is not an exclusion provided there is natural free drainage or a Seton suture(s) have been placed. c)History of tuberculosis or at current increased risk of tuberculosis d)Mantoux test result or other investigations that the investigator or Steering Committee regard as evidence of active tuberculosis. e)Abnormal chest x ray (CXR) consistent with active infection or neoplasm. 5)Significant malnutrition: Body Mass Index (BMI) ≤ 18, serum albumin <=20 g/l 6)Previous poor compliance 7)Concurrent enrolment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry. 8)Lack of funding
研究者
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