title: Oral mixture of autologous colon-extracted proteins for the Crohn's disease: A double-blind trial.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of oral administration of Alequel™, an autologous protein-containing 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Eran
authors.initials: E
authors.lastname: Israeli
authors.affiliation: 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.
authors.forename: Ehud
authors.initials: E
authors.lastname: Zigmond
authors.affiliation: 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.
authors.forename: Gadi
authors.initials: G
authors.lastname: Lalazar
authors.affiliation: 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.
authors.forename: Athalia
authors.initials: A
authors.lastname: Klein
authors.affiliation: 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.
authors.forename: Nilla
authors.initials: N
authors.lastname: Hemed
authors.affiliation: 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.
authors.forename: Eran
authors.initials: E
authors.lastname: Goldin
authors.affiliation: 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.
authors.forename: Yaron
authors.initials: Y
authors.lastname: Ilan
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002469:Cell Separation / Q000379:methods; D003106:Colon / Q000187:drug effects* / Q000276:immunology / Q000378:metabolism; D003424:Crohn Disease / Q000175:diagnosis / Q000276:immunology / Q000378:metabolism / Q000628:therapy*; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D005434:Flow Cytometry; D006801:Humans; D007108:Immune Tolerance / Q000187:drug effects; D018928:Immunity, Mucosal / Q000187:drug effects; D007557:Israel; D008297:Male; D008875:Middle Aged; D011506:Proteins / Q000008:administration & dosage* / Q000276:immunology / Q000302:isolation & purification; D012074:Remission Induction; D012720:Severity of Illness Index; D016176:T-Lymphocyte Subsets / Q000187:drug effects / Q000276:immunology; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D011506:Proteins
keywords: Crohn’s disease; Immune modulation; Natural killer T cells; Oral tolerance