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Oral mixture of autologous colon-extracted proteins for the Crohn's disease: A double-blind trial

World Journal of Gastroenterology 2015年第18期21卷 5685-5694页

作者： Eran Israeli Ehud Zigmond Gadi Lalazar Athalia Klein nilla Hemed Eran Goldin Yaron Ilan Gastroenterology and Liver Units Department of Medicine Hebrew University-Hadassah Medical Center IL 91120 Jerusalem Israel

AIM: To evaluate the safety and efficacy of oral administration of AlequelTM, an autologous proteincontaining colon extract.a randomized,placebo-controlled,double-blind *** were orally administered with autologous protein-containing colon extract three doses of autologous study drug per week for 15 wk,for a total of45 *** were followed for safety *** was defined as a Crohn’s disease activity index(CDAI)score of less than or equal to *** patients were followed for changes in subsets of T cells by fluorescence-activated cell sorting ***:Analysis was performed on a total number of evaluable patients of 14 in the study drug group and15 in the placebo *** was well tolerated by all *** major treatment-related adverse events were reported or observed in any of the treated patients during the feeding or follow-up *** weeks 6 and 9 of the study,six of the 14(43%)evaluable subjects who received the study drug achieved a CDAI of 150 or *** contrast,five of the 15(33%)evaluable subjects in the placebo group achieved *** weeks 9 and 12,the remission rates were 50%and 33%for the drug group and placebo group,*** the drug-treated subjects who achieved remission,the effect of the drug was judged as stable in eight of the 14 subjects as measured by at least two CDAI scores indicating remission in the 15-wk treatment period.A decreased percentage of peripheral natural killer T regulatory cells(a decrease of 28%vs an increase of 16%)and an increased ratio of CD4+/CD8+T lymphocytes(an increase of 11%vs a decrease of9%)were noted in subjects with a significant clinical ***:Oral administration of the autologous colonic extract could be a safe and effective for the treatment of patients with moderate to severe Crohn’s disease.

关键词： Oral tolerance Crohn’s disease Natural killer T cells Immune modulation

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Oral immune regulation using colitis extracted proteins for treatment of Crohn's disease: Results of a phase Ⅰ clinical trial

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World Journal of Gastroenterology 2005年第20期11卷 3105-3111页

作者： Eran Israeli Eran Goldin Oren Shibolet Athalia Klein nilla Hemed Dean Engelhardt Elazar Rabbani Yaron Ilan Gastroenterology and Liver Units Department of Medicine Hebrew University-Hadassah Medical Center Jerusalem Israel Enzo Biochem New York NY USA

AIM: To evaluate safety and possible efficacy of induction of oral immune regulation using colitis extracted proteins(CEP) in Crohn's disease (CD) ***: Ten CDs were treated orally with autologous CEP thrice weekly for 16 wk. Subjects were monitored for CDAI and IBDQ. Immune modulatory effect was assessed by T-lymphocyte FACS analysis, CEP-specific IFNγ ELISPOT assay and cytokine ***: Induction of oral immune regulation significantly ameliorated disease activity. All (10/10) subjects had clinical response (CDAI≤70) and 7/10 achieved clinical remission (CDAI≤150). Significant increase in mean IBDQ score was noted (134±9vs 164±12). No treatment-related adverse events were noted. High levels of CEP-specific IFNγ spot forming colonies were detected in five subjects prior to treatment and in all five, a marked decrease was observed. The CD4+/CDS+ lymphocyte ratio and peripheral NKT cell numbers increased significantly, in 7/10 and in 5/10 subjects, respectively. Significant increase in serum IL-10 and IL-4 levels was observed in 7/10 subjects during treatment ***: Immune regulation via oral administration of CEP is a safe and possibly effective treatment for subjects with moderate CD and may provide means of antigen-specific immune modulation.

关键词：免疫反应大肠疾病萃取蛋白克罗恩病节段性肠炎

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