Blood purification systems may be improved as the result of an invention whereby activated charcoal can be supported within a reticulated polyurethane matrix such that both the polyurethane and the activated charcoal have potential activity for removal of toxicants and drugs from whole blood or plasma. The spongy matrix containing activated charcoal will be referred to here as """"""""Charcoal-Biosponge"""""""". It can be formulated with low resistance to blood flow, and blood filtration does not cause red-cell lysis. The matrix also can support iron chelation materials to reduce iron overload and/or enzymes with catalytic properties appropriate for treatment of specific metabolic disorders. This feature enhances the prospects for """"""""artificial kidney"""""""" devices based on these materials. The objective of the proposed Phase I study is to evaluate the potential of Charcoal-Biosponge filters to complement or replace the blood-filtration systems currently marketed. The evaluation will involve (1) quantitation of drug removal from whole blood and/or plasma by varied formulations of Charcoal-Biosponge containing different types of charcoals, (2) quantitation of the effect of Charcoal-Biosponge filtration on platelet aggregation and red-cell function (to include assays of red-cell fragility and, after filtration, the oxygen-binding characteristics of red cells from patients with HbA and HbS) and on the levels of total protein, albumin, urea nitrogen, lipoprotein, aminophylline, and fibrinogen in the filtrate, and (3) evaluation of materials or chemicals (if any) that leach from the Charcoal-Biosponge when rinsed with either Ringer's solution or plasma. It is anticipated that these studies will be followed by a Phase II effort focused on evaluation of iron removal and correction of metabolic deficiencies via co-incorporation of appropriate enzymes.
