Book Review By Liisa Kuhn, PhD., Asst. Professor, University ofConnecticut Health Center, Center for Biomaterials, Farmington, CT06107, Lkuhn@uchc.edu

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

This is a unique monograph exploring not only the clinical andscientific aspects of bone grafting, but also the practical issueof bringing promising new bone graft substitutes to the marketplacein a fashion which insures their safety and efficacy. Dr.Laurencin, with help from Dr. Mohamed Attawia, assembled anaccomplished multidisciplinary panel of scientists, clinicians andmembers of the regulatory agencies for a workshop held at theAmerican Society of Testing and Materials Fall Committee week in2000. This volume represents, in large part, the proceedings fromthat workshop on Bone Graft Substitutes. Together the panel membershave collectively authored a comprehensive and authoritativesummary of this complex field.

This monograph is divided into three sections. The first sectionpresents a summary of the clinical use of bone allografts andallograft-based bone graft substitutes. The second sectionaddresses the use of cells and growth factors as bone graftsubstitutes. Representatives from academia, industry and theregulatory communities present their perspectives on the excitingopportunities and formidable challenges involved in bringingscientific advances in the field of bone tissue engineering to thepatient care arena. The final section addresses the use ofsynthetic materials, including polymers and ceramics for bone graftsubstitutes. All sections begin with an overview by some of theleading authorities in the field. The issues involved in standardsdevelopment for bone graft substitutes are addressed in eachsection and provide motivation to become involved with ASTMCommittee F04 on Medical and Surgical Devices. The contributingauthors can be found by going to http://www.astm.org/sitesearch andentering MONO6.

It is rare to find such thorough topic coverage in a conferenceproceedings. It is reminiscent of a classic 1994 monograph I haveon the same subject entitled "Bone Grafts, Derivatives andSubstitutes" edited by MR Urist, BT O'Connor, and RG Burwell,published by Butterworth Heinemann, England. The main differencebetween that text and this one edited by C. Laurencin is thecoverage of tissue engineering approaches that were not yetdeveloped enough to be included in the earlier text on bonesubstitutes. I believe clinicians will find this new monograph anexcellent addition to their personal library as a self-educationalresource because of the thorough coverage of the topic area. Thismonograph is also an excellent resource for academic or corporateresearchers because in addition to containing the essential basicscience components, important aspects of product development andregulatory pathways are covered that may influence researchdirection.

Audience
Clinical, corporate and academic researchers working in the fieldof biomaterials. University libraries and biomedical engineeringdepartment libraries. Excellent resource for clinicians interestedin learning about cell-based and growth factor delivery systems,and for students beginning study in this area. Researchers in thisarea will appreciate the focused content as background informationfor grant proposals.

Over 35 RECOGNIZED EXPERTS provide not only the CLINICAL ANDSCIENTIFIC ASPECTS of BONE GRAFTING, but also the PRACTICAL ISSUESof bringing promising new bone graft substitutes to the marketplacein a fashion which INSURES THEIR SAFETY AND EFFICACY.

Co-published by ASTM International and The American Academy ofOrthopedic Surgeons

What are the current and future challenges of bone graftsubstitutes?

GET THE ANSWERS YOU NEED in this unique new publication whichrepresents 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 ofsubstitutes with special attention to enormously important issuesinvolving both the regulation of these materials and thedevelopment of standards for fabrication and characterization.

Section 1 presents a summary of the clinical use of boneallografts and allograft-based bone graft substitutes. Chaptersinclude:

• Review of the State of the Art: Allograft Based Systems forUse as Bone Graft Substitutes

• Musculoskeletal Allograft Tissue Banking and Safety

• Clinical Perspective on the Use of Bone Graft Based onAllografts

• Development of Bone Graft Materials Using Various Formulationsof Demineralized Bone Matrix

• Standards Development Perspectives on the Use of Bone GraftSubstitutes Based Upon Allografts

Section II addresses the use of cells and growth factorson bone graft substitutes. Representatives from academia, industry,and the regulatory communities present their perspectives on theformidable challenges involved in bringing scientific advances inthe 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 Useas Bone Graft Substitutes

• Preclinical, Clinical, and Regulatory Issues in Cell-BasedTherapies

• Factor Based Systems for Use as Bone Graft Substitutes: AReview of the State of the Art:

• Bone Morphogenetic Protein (BMP) Implants As Bone GraftSubstitutes -- Promises and Challenges

• Bone Graft Substitutes: A Regulatory Perspective

Section III covers synthetic materials, includingpolymers and ceramics, for bone graft substitutes. Chapterscover:

• Basic Information for Successful Clinical Use With SpecialFocus On Synthetic Graft Substitutes

• Calcium Sulfate Based Bone Substitutes

• Development of Corralline Porous Ceramic Graft Substitutes

• Clinical Issues in the Development of Bone Graft Substitutesin Orthopaedic Trauma Care

• Issues Involving Standards Development for Synthetic MaterialBone Graft Substitutes

This volume is a valuable resource for orthopedic surgeons,biomedical engineers, biologists, researchers and FDApersonnel.