TY - JOUR
T1 - Oral mixture of autologous colon-extracted proteins for the Crohn's disease
T2 - A double-blind trial
AU - Israeli, Eran
AU - Zigmond, Ehud
AU - Lalazar, Gadi
AU - Klein, Athalia
AU - Hemed, Nilla
AU - Goldin, Eran
AU - Ilan, Yaron
N1 - Publisher Copyright:
© The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
PY - 2015/5/14
Y1 - 2015/5/14
N2 - AIM: To evaluate the safety and efficacy of oral administration of Alequel™, an autologous proteincontaining colon extract. METHODS: A total of 43 patients were enrolled in a randomized, placebo-controlled, double-blind trial. Patients were orally administered with autologous protein-containing colon extract three doses of autologous study drug per week for 15 wk, for a total of 45 doses. Patients were followed for safety parameters. Remission was defined as a Crohn's disease activity index (CDAI) score of less than or equal to 150. All patients were followed for changes in subsets of T cells by fluorescence-activated cell sorting analysis. RESULTS: Analysis was performed on a total number of evaluable patients of 14 in the study drug group and 15 in the placebo group. Treatment was well tolerated by all patients. No major treatment-related adverse events were reported or observed in any of the treated patients during the feeding or follow-up periods. Between 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 lower. In contrast, five of the 15 (33%) evaluable subjects in the placebo group achieved remission. Between weeks 9 and 12, the remission rates were 50% and 33% for the drug group and placebo group, respectively. Among 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 of 9%) were noted in subjects with a significant clinical response. CONCLUSION: 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.
AB - AIM: To evaluate the safety and efficacy of oral administration of Alequel™, an autologous proteincontaining colon extract. METHODS: A total of 43 patients were enrolled in a randomized, placebo-controlled, double-blind trial. Patients were orally administered with autologous protein-containing colon extract three doses of autologous study drug per week for 15 wk, for a total of 45 doses. Patients were followed for safety parameters. Remission was defined as a Crohn's disease activity index (CDAI) score of less than or equal to 150. All patients were followed for changes in subsets of T cells by fluorescence-activated cell sorting analysis. RESULTS: Analysis was performed on a total number of evaluable patients of 14 in the study drug group and 15 in the placebo group. Treatment was well tolerated by all patients. No major treatment-related adverse events were reported or observed in any of the treated patients during the feeding or follow-up periods. Between 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 lower. In contrast, five of the 15 (33%) evaluable subjects in the placebo group achieved remission. Between weeks 9 and 12, the remission rates were 50% and 33% for the drug group and placebo group, respectively. Among 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 of 9%) were noted in subjects with a significant clinical response. CONCLUSION: 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.
KW - Crohn's disease
KW - Immune modulation
KW - Natural killer T cells
KW - Oral tolerance
UR - http://www.scopus.com/inward/record.url?scp=84929168189&partnerID=8YFLogxK
U2 - 10.3748/wjg.v21.i18.5685
DO - 10.3748/wjg.v21.i18.5685
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C2 - 25987796
AN - SCOPUS:84929168189
SN - 1007-9327
VL - 21
SP - 5685
EP - 5694
JO - World Journal of Gastroenterology
JF - World Journal of Gastroenterology
IS - 18
ER -