Mesenchymal stem cell therapy for the treatment of severe or refractory inflammatory and/or autoimmune disorders.

CHU-ULg0 个研究点目标入组 20 人开始时间: 2011年12月12日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•1-Age between 18 and 75 years old
•2-Crohn’s disease affecting terminal ileum, colon or both with diagnosis confirmed according to Lennard Jones criteria
•3-Clinically active disease with a CDAI between 220 and 450 and biologically active disease with a CRP > 5 mg/l and/or fecal calprotectin > 150 microg/g
•4-Resistance or intolerance to mesalazine, steroids, purine analogues, methotrexate, infliximab and adalimumab
•5-Adequate venous access (central catheter or good peripheral veins)
•6-Willingness to sign the informed consent and enter the clinical 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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1-Any condition not fulfilling inclusion criteria
•2-Indication for surgery
•3-Symptomatic stricture
•4-Undrained perianal or intraabdominal abscess
•5-Change in mesalazine dosage within the last 4 weeks, change in steroid dosage within the last two weeks, change in immunosuppressant dosage within the last 3 months, use of anti-TNF treatment within the last two months
•6-HIV positive
•7-Uncontrolled infection, arrhythmia or hypertension
•8-Terminal organ failure:
•a.Renal: anuria, serious fluid overload, GFR < 30 ml/min, dialysis;
•b.Pulmonary: DLCO < 35% and/or receiving supplementary continuous oxygen;
•c.Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL, and symptomatic biliary disease;
•d. Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring therapy; ejection fraction <35%; uncontrolled arrhythmia, uncontrolled hypertension

发起方

CHU-ULg