Ex Vivo Biocompatibility of a New ß 2 -Microglobulin Hemoperfusion Polymer

Abstract

ß₂-microglobulin (ß₂-m) is an 11.8 kD protein that is excreted by the kidneys. In renal insufficiency, it accumulates in the body and can result in AB amyloidosis with bone and joint destruction.

Four modifications of a new ß₂-m adsorbent material were tested for biocompatibility with human whole blood. 500 ml of heparinized blood from healthy human donors was perfused ex vivo through minicolumns (adsorber beads: divinylbenzene with different biocompatible coatings) in the single-pass mode. Blood samples were taken from the antecubital vein before and at the column outlet during the 50 min test runs.

Red and white cell counts remained virtually constant. No signs of hemolysis could be detected. Thrombogenicity of the columns was low as shown by the insignificant platelet loss, only slight platelet activation and moderate thrombin-antithrombin formation. There was no activation of leukocytes nor monocytes. Complement and bradykinin activation was minimal. Electrolyte concentrations and pH remained essentially constant.

In conclusion, this new ß₂-m adsorbent material exhibited favorable biocompatibility features in our ex vivo model and is thus a promising candidate for future clinical ß₂-m hemoperfusion studies in patients.