Natural Mixtures from Expired Human Platelets for Periodontal Tissue Engineering

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DESCRIPTION (provided by applicant): Some 1.8 million regenerative dental procedures were done in the U.S. in 2006. Of these, about 20% used a wound-healant product such as a recombinant growth factor (RGF) or concentrates of a patient's own platelets [requiring the use of a platelet concentrating system (PCS)]. Wound-healants are used as an attempt to accelerate healing and to improve patient outcomes-especially in larger regenerative procedures and in compromised patients. However, although the wound-healants are key tools for periodontists and oral surgeons to use in pursuing improved patient outcomes, the currently available products result in inconsistent efficacy and are expensive. A product that is consistently effective and much more economical would be of major importance to the dental surgery professional, as it would allow for greater adoption and improved outcomes of dental regenerative treatment procedures. Developing and commercializing that next- generation wound-healant for periodontal applications is the goal of this multi-phase STTR project. Snoasis Medical proposes a unique source of growth factors and a technique that together could lead to the ideal wound-healant product. Expired units of banked human platelets (currently costing only $50) are an excellent, low-cost source from which to develop such a product. What is needed to move forward with this innovative approach is the validation of a proprietary processing method that gives high yields of safe material that exhibits quantifiable biologic activity. Thus, the overall goal of this multi-phase STTR project is to show that this new method will yield a safe material of consistent composition that enables low-cost and high-performance application in periodontal regenerative procedures. Preliminary Snoasis data demonstrates that our method can yield a product with bioactivity superior to that of rhPDGF in vivo. To fully establish the feasibility of this approach, we will pursue the following Specific Aims: 1) Prove that extracts produced from units of expired human banked platelets contain growth factors key to wound-healing and angiogenesis; 2) Using a Matrigel plug assay in mice, prove that these platelet extracts exhibit angiogenic activity at a level sufficient to a) form a total of at least 5 functional capillaries in separate plugs placed in five mice with a dose of 10 <g/plug; b) show antibacterial activity in culture against Porphyromonas Gingivalis, a key periodontal pathogen; and c) maintain pyrogen levels considered safe by the FDA (less than 0.5 EU/300<g); and 3) Prove that a majority of these batches exhibit bioactivity superior to that of rhPDGF-BB. Snoasis will pursue these three aims with a highly experienced R&D team headed by STTR Principal Investigator Mark Roedersheimer and including three additional Ph.D.- or MD-level researchers. The anticipated Phase I success will set the stage for a follow-on Phase II project designed to validate the potential therapeutic value of the novel extracts developed during Phase I by testing them in a higher animal model. Phase II work will be designed to produce the data needed to attract "Phase III" commercial partners/investors. PUBLIC HEALTH RELEVANCE: In 2006, some 1.8 million dental procedures in the U.S. made use of a regenerative tissue product or an autograft harvested from the patient's mouth to treat serious tissue loss around teeth-with that number projected to increase at a rate of 16% over the next five years. And although it is estimated that wound- healant products are used in approximately 20% of all dental regenerative procedures, current-generation products do not fully meet the needs of periodontists and oral surgeons-often producing inconsistent results and/or proving to be very expensive (often prohibitively so). The goal of this multi-phase STTR project is to develop, validate, and commercialize the needed next-generation wound-healant that periodontists and oral surgeons can use to effectively and economically treat their patients who suffer from tissue degeneration that leads to tooth loss and threatens oral health.