Design and development of a bioresorbable bone graft

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DESCRIPTION (provided by applicant): The long-term goal of this project is to develop a safe, cost-effective, off-the-shelf, and well characterized bone filler material based on plastics derived from blood byproducts. Over 800,000 bone procedures are performed in the US per year, and with the aging US population, this number will only continue to grow. However, current materials, including autografts, allografts, and engineered biomaterials, all fall short of clinical expectations for reasons such as cost, disease transmission concerns, bone donation issues and complications, and lack of well characterized and consistently performing products. Blood byproduct-based plastics have the potential to overcome these limitations. The Phase I hypothesis is that these plastics can be engineered to have desired mechanical and degradation properties, demonstrate biocompatibility in vitro, and lead to bone formation in an in vivo critical-sized defect model. To test this hypothesis, the Young's Modulus of various plastic formulations will be examined. In vitro degradation of these plastics, in the presence of cellular proteases, will then be examined spectroscopically. Plastics with desirable mechanical and degradation properties will then be studied for their in vitro biocompatibility and proliferative effect on cultured cells using standard commercial assays. Finally, in vivo bone formation capacity will be investigated in a pilot study utilizing a mouse calvarial defect model. In Phase II, larger scale investigations in two standardized animal bone defect models will be used to further develop these plastics and provide preliminary data for FDA submission. PUBLIC HEALTH RELEVANCE: The aging population coupled with their increased activity has raised demand for effective bone graft materials. Current clinical materials fall short of many of the expectations of clinicians for reasons such as inconsistent outcomes, inadequate supply, and cost. CarMell has developed a material made from human blood byproducts that has the potential to be a safe, cost-effective, off-the-shelf, and consistent bone graft therapy.