| Pilot feasibility studies of leukocytapheresis with the Adacolumn Apheresis System in patients with active ulcerative colitis or Crohn disease. | |
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MedLine Citation:
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PMID: 16825929 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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GOALS: Two uncontrolled, multicenter feasibility studies evaluated safety and pilot efficacy of selective granulocyte and monocyte adsorption apheresis (GMA) with the Adacolumn Apheresis System for treatment of moderate-to-severe ulcerative colitis (UC) and Crohn disease (CD) patients refractory/intolerant to conventional pharmacologic therapy. BACKGROUND: Patients with UC and CD, characterized by elevations in peripheral blood granulocytes, monocytes/macrophages, and proinflammatory mediators, may benefit from reductions in activated granulocytes and monocytes by selective apheresis. METHODS: Patients underwent weekly Adacolumn sessions for 5 weeks. Pilot efficacy assessments used disease activity index (DAI) for UC (0-12) or CD activity index (CDAI; 0-600) for CD. RESULTS: Eleven of 15 UC patients completed all 5 treatments. Mean DAI scores fell from 8.4+/-1.3 (baseline) to 5.2+/-2.9 (week 7). Five patients had DAI reductions of > or = 3 points at week 7. Fourteen of 15 CD patients completed all 5 treatments. Mean CDAI scores fell from 308.0+/-76.5 (baseline) to 200.6+/-117.4 (week 7). Nine CD patients responded (CDAI reductions > or = 70 points) at week 7. Remission (CDAI score < or = 150 at week 7) was observed in 6 patients. There were no device-related serious adverse effects. CONCLUSIONS: Treatment with Adacolumn may be feasible and effective in patients with moderate-to-severe refractory inflammatory bowel disease. Larger sham-controlled studies are ongoing. |
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Authors:
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Bruce E Sands; William J Sandborn; Douglas C Wolf; Seymour Katz; Michael Safdi; David A Schwartz; Stephen B Hanauer |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of clinical gastroenterology Volume: 40 ISSN: 0192-0790 ISO Abbreviation: J. Clin. Gastroenterol. Publication Date: 2006 Jul |
Date Detail:
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Created Date: 2006-07-07 Completed Date: 2006-11-14 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 7910017 Medline TA: J Clin Gastroenterol Country: United States |
Other Details:
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Languages: eng Pagination: 482-9 Citation Subset: IM |
Affiliation:
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Gastrointestinal Unit and MGH Crohn's and Colitis Center, Massachusetts General Hospital, Boston, MA 02114, USA. bsands@partners.org |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adsorption Adult Aged Anti-Inflammatory Agents / pharmacology Colitis, Ulcerative / pathology, physiopathology, therapy* Crohn Disease / pathology, physiopathology, therapy* Drug Resistance / drug effects Equipment Design Feasibility Studies Female Humans Immunosuppressive Agents / pharmacology Leukapheresis / instrumentation*, methods Male Middle Aged Pilot Projects Remission Induction Severity of Illness Index Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents; 0/Immunosuppressive Agents |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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