Book Review By Liisa Kuhn, PhD., Asst. Professor, University of Connecticut Health Center, Center for Biomaterials, Farmington, CT 06107, Lkuhn@uchc.edu

Bone Graft Substitutes
Edited by Cato T. Laurencin, MD, PhD

This is a unique monograph exploring not only the clinical and scientific aspects of bone grafting, but also the practical issue of bringing promising new bone graft substitutes to the marketplace in a fashion which insures their safety and efficacy. Dr. Laurencin, with help from Dr. Mohamed Attawia, assembled an accomplished multidisciplinary panel of scientists, clinicians and members of the regulatory agencies for a workshop held at the American Society of Testing and Materials Fall Committee week in 2000. This volume represents, in large part, the proceedings from that workshop on Bone Graft Substitutes. Together the panel members have collectively authored a comprehensive and authoritative summary of this complex field.

This monograph is divided into three sections. The first section presents a summary of the clinical use of bone allografts and allograft-based bone graft substitutes. The second section addresses the use of cells and growth factors as bone graft substitutes. Representatives from academia, industry and the regulatory communities present their perspectives on the exciting opportunities and formidable challenges involved in bringing scientific advances in the field of bone tissue engineering to the patient care arena. The final section addresses the use of synthetic materials, including polymers and ceramics for bone graft substitutes. All sections begin with an overview by some of the leading authorities in the field. The issues involved in standards development for bone graft substitutes are addressed in each section and provide motivation to become involved with ASTM Committee F04 on Medical and Surgical Devices. The contributing authors can be found by going to http://www.astm.org/sitesearch and entering MONO6.

It is rare to find such thorough topic coverage in a conference proceedings. It is reminiscent of a classic 1994 monograph I have on the same subject entitled "Bone Grafts, Derivatives and Substitutes" edited by MR Urist, BT O'Connor, and RG Burwell, published by Butterworth Heinemann, England. The main difference between that text and this one edited by C. Laurencin is the coverage of tissue engineering approaches that were not yet developed enough to be included in the earlier text on bone substitutes. I believe clinicians will find this new monograph an excellent addition to their personal library as a self-educational resource because of the thorough coverage of the topic area. This monograph is also an excellent resource for academic or corporate researchers because in addition to containing the essential basic science components, important aspects of product development and regulatory pathways are covered that may influence research direction.

Audience
Clinical, corporate and academic researchers working in the field of biomaterials. University libraries and biomedical engineering department libraries. Excellent resource for clinicians interested in learning about cell-based and growth factor delivery systems, and for students beginning study in this area. Researchers in this area will appreciate the focused content as background information for grant proposals.

Over 35 RECOGNIZED EXPERTS provide not only the CLINICAL AND SCIENTIFIC ASPECTS of BONE GRAFTING, but also the PRACTICAL ISSUES of bringing promising 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.