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P246. Technical performance of a novel adsorptive type cytapheresis module in patients with moderately to severely active ulcerative colitis

G. Waitz1, H. Prophet2, G. Sparmann1, J. Emmrich3, W. Ramlow2

1BioArtProducts GmbH, Rostock, Germany; 2Apheresis Center Rostock, Rostock, Germany; 3Division of Gastroenterology, University of Rostock, Rostock, Germany

Aim: To evaluate the technical performance and biocompatibility of a novel cytapheresis module in patients with active ulcerative colitis (UC).

Materials and Methods: 10 patients with moderately to severely active UC, defined by Clinical Activity Index (CAI according to Rachmilewitz: 6–10), who have failed to achieve long-term remission with steroids and/or immunosuppressants or who were contraindicated or intolerant to steroids and/or immunosuppressants were recruited. The investigational device was an adsorptive type cytapheresis device (Immunopure®, Nikkiso, Japan) that has been specifically designed to be used in a simple hemoperfusion setting for the removal of activated granulocytes, monocytes and platelets. All patients were scheduled to receive 5 apheresis sessions at weekly intervals (week 1–5) with a treatment duration of 60 min (blood flow of 30 ml/min, anticoagulation by standard heparin). Technical performance was investigated by repeated measurements of cellular blood counts, complement factor C3a as well as different cell surface markers by flow cytometry.

Results: Cellular blood counts showed that platelets (to 20%), monocytes (to 34%) and neutrophil granulocytes (to 53%) were effectively reduced during the treatment at the column outlet. In contrast, lymphocytes were only moderately depleted (to 94%), while red blood cells were not influenced by the device. Flow cytometry data revealed significant reductions of CD10+ granulocytes, CD14+ monocytes, CD62L+ cells, CD11b+ cells, CD3+HLADR+ cells, while there was only little impact on CD3+CD4+, CD3+CD8+ cells. CD42b+CD63+ activated platelets were significantly increased especially in the column outflow. CD4+CD25+FoxP3+ cells were increased after 15 min in the outflow, but decreased at the end of the treatment.

Levels of complement factor C3a were not significantly increased suggesting a high biocompatibility of the column material. This is also reflected by a slight decrease of CD62L mean channel fluorescence and a relative low increase of CD11b mean channel fluorescence.

Conclusion: During this pilot trial with 10 active UC patients the novel semi-selective device Immunopure® has been shown to be highly biocompatible and technically effective. Notably, the material is characterized by high removal capacities for platelets, granulocytes and monocytes.