new bone graft substitutes to the marketplace in a fashion which insures their safety and efficacy. Co-published by ASTM International and The American Academy of Orthopedic Surgeons What are the current and future challenges of bone graft substitutes? Get the answers you need in this unique new publication which represents the latest research of a distinguished panel of authors, recognized leaders in their respective scientific, clinical, & regulatory fields. It provides an in-depth discussion of the various classes of substitutes with special attention to enormously important issues involving both the regulation of these materials and the development of standards for fabrication and characterization. Section 1 presents a summary of the clinical use of bone allografts and allograft-based bone graft substitutes. Chapters include: • Review of the State of the Art: Allograft Based Systems for Use as Bone Graft Substitutes • Musculoskeletal Allograft Tissue Banking and Safety • Clinical Perspective on the Use of Bone Graft Based on Allografts • Development of Bone Graft Materials Using Various Formulations of Demineralized Bone Matrix • Standards Development Perspectives on the Use of Bone Graft Substitutes Based Upon Allografts Section II addresses the use of cells and growth factors on bone graft substitutes. Representatives from academia, industry, and the regulatory communities present their perspectives on the formidable challenges involved in bringing scientific advances in the field of bone tissue engineering to the patient care arena. Chapters include: • Cell Based Approach for Bone Graft Substitutes • Clinical Issues in the Development of Cellular Systems for Use as Bone Graft Substitutes • Preclinical, Clinical, and Regulatory Issues in Cell-Based Therapies • Factor Based Systems for Use as Bone Graft Substitutes: A Review of the State of the Art: • Bone Morphogenetic Protein (BMP) Implants As Bone Graft Substitutes -- Promises and Challenges • Bone Graft Substitutes: A Regulatory Perspective Section III covers synthetic materials, including polymers and ceramics, for bone graft substitutes. Chapters cover: • Basic Information for Successful Clinical Use With Special Focus On Synthetic Graft Substitutes • Calcium Sulfate Based Bone Substitutes • Development of Corralline Porous Ceramic Graft Substitutes • Clinical Issues in the Development of Bone Graft Substitutes in Orthopaedic Trauma Care • Issues Involving Standards Development for Synthetic Material Bone Graft Substitutes This volume is a valuable resource for orthopedic surgeons, biomedical engineers, biologists, researchers and FDA personnel

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