SBIR-STTR Award

Hemodialysis is widely used to sustain life in individuals who have lost kidney function. The membrane material most commonly used for this purpose is regenerated cellulose. However, regenerated cellulose is not inert; it stimulates the coagulation and complement systems and may be a cause of both acute and chronic morbidity for the patient. Further, its physical properties limit methods of sterilization and its usefulness for multiple use. A substitute for regenerated cellulose is being sought by device manufacturers.The objective of this program is to develop alternatives to regenerated cellulose. A variety of polymers will be formulated that should possess superior biocompatibility to regenerated cellulose, that have physical properties suited to reuse and alternative methods of sterilization, and that can be fabricated into membranes by economically viable methods. The membranes- will be tested in vitro to(1) compare their biocompatibility to regenerated cellulose,(2) examine their thrombogenic potential,(3) evaluate their propensity to activate complement, and(4) assess their direct action, if any, on the cellular components of blood.University Medical Associates will ensure the materials are resistant to the chemicals used for dialyzer reuse and that they can be fabricated into membranes with mass transfer properties suitable for hemodialysis. In Phase II of the program, the most promising materials will be fabricated into dialyzers and the results confirmed in vivo using an animal model. This will lead to the development and clinical trials of clinical dialyzers.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Hemodialysis is widely used to sustain life in individuals without kidney function. The membrane material most commonly used for this purpose is regenerated cellulose. Regenerated cellulose is not completely biocompatible; it stimulates the coagulation and complement systems and ma be a cause of both acute and chronic morbidity for the patient. Further, its mass transfer properties are limited, as are methods of sterilization. Substitutes for regenerated cellulose are being sought. In Phase I of thi program, the biocompatibility of a number of materials which might replace regenerated cellulose was examined. Two polymers with improved biocompatibility compared to regenerated cellulose were identified. The feasibility of fabricating these polymers into membranes suitable for hemodialysis was also demonstrated. In Phase II, we will determine the casting conditions necessary to produce membranes of the appropriate mechanical and mass transfer properties for hemodialysis from these polymers. The biocompatibility of the membranes will then be confirmed using a model which reproduces the conditions of hemodialysis. The abilit of the membranes to retain their properties following exposure to the chemicals used in the multiple use of dialyzers will also be confirmed. Finally, preliminary toxicity testing of the membranes will be performed a a prelude to clinical trials.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)