preface

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ALES PROKOP Chemical Engineering Department Vanderbilt University, 107 Olin Hall Nashville, Tennessee 37235 DAVID HUNKELER Laboratory of Polymers and Biomaterials Department of Chemistry Swiss Institute of Technology (EPFL) CH-1015 Lausanne, Switzerland ALAN D. CHERRINGTON Department of Molecular Physiology and Biophysics Vanderbilt University School of Medicine Nashville, Tennessee 37232 Bioartificial Organs is an interdisciplinary domain comprising biological sciences, chemistry, physical chemistry, material science, polymer chemistry, cell culture, recombinant DNA technology, bioprocess engineering and clinical sciences. To continue and enhance the rate of research progress it is necessary to promote effective communication between these diverse groups. A symposium entitled Bio- artificial Organs: Science and Technology was held from July 21-26, 1996 in Nash- ville, Tennessee (USA), under the aegis of the Engineering Foundation Confer- ences. Approximately 100 scientists, medical professionals, and engineers attended the meeting, with the approximate breakdown of attendees between different cate- gories as follows: medical professionals and biological scientists 54%, polymer scien- tists 18% and engineers 28%. The conference included representatives from 11 countries, three national regulatory agencies, and 19 private companies. This book is a collection of the majority of papers presented at this meeting grouped under common themes, rather than in the order presented. The book is organized into eight sections. The Overview provides a look at the current state of bioartificial organ research, challenges, as well as emerging regulatory and ethical issues. Part I1 discusses the synthesis of novel polymeric biomaterials, while Parts I11 and IV present surface characterization and technological issues, respectively. The second half of the book is medically and clinically oriented, with Part V presenting an overview of artificial cells, immunoisolation and organ regeneration. Specific sec- tions are also dedicated to the bioartificial pancreas (Part VI) and bioartificial liver (Part VII). Finally, the application of tissue engineering to uses involving scaffold matrices for cartilage constructs, bone regeneration, immunoregulation, and gene therapy are discussed in Part VIII. The editors would like to thank the members of the organizing committee of the symposium consisting of Todd Giorgio (Vanderbilt), Milton Harris (University of Alabama), Kiki Hellman (FDA), Jeffrey Hubbell (Caltech), Robert Langer (MIT), Alan Laskin (Engineering Foundation), Kenneth Luskey (Metabolex), Alvin Powers (Vanderbilt), Paul Kemp (Organogenesis), Anthony M. Sun (University of xi

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ALES PROKOP Chemical Engineering Department

Vanderbilt University, 107 Olin Hall Nashville, Tennessee 37235

DAVID HUNKELER Laboratory of Polymers and Biomaterials

Department of Chemistry Swiss Institute of Technology (EPFL)

CH-1015 Lausanne, Switzerland

ALAN D. CHERRINGTON Department of Molecular Physiology and Biophysics

Vanderbilt University School of Medicine Nashville, Tennessee 37232

Bioartificial Organs is an interdisciplinary domain comprising biological sciences, chemistry, physical chemistry, material science, polymer chemistry, cell culture, recombinant DNA technology, bioprocess engineering and clinical sciences. To continue and enhance the rate of research progress it is necessary to promote effective communication between these diverse groups. A symposium entitled Bio- artificial Organs: Science and Technology was held from July 21-26, 1996 in Nash- ville, Tennessee (USA), under the aegis of the Engineering Foundation Confer- ences. Approximately 100 scientists, medical professionals, and engineers attended the meeting, with the approximate breakdown of attendees between different cate- gories as follows: medical professionals and biological scientists 54%, polymer scien- tists 18% and engineers 28%. The conference included representatives from 11 countries, three national regulatory agencies, and 19 private companies. This book is a collection of the majority of papers presented at this meeting grouped under common themes, rather than in the order presented. The book is organized into eight sections. The Overview provides a look at the current state of bioartificial organ research, challenges, as well as emerging regulatory and ethical issues. Part I1 discusses the synthesis of novel polymeric biomaterials, while Parts I11 and IV present surface characterization and technological issues, respectively. The second half of the book is medically and clinically oriented, with Part V presenting an overview of artificial cells, immunoisolation and organ regeneration. Specific sec- tions are also dedicated to the bioartificial pancreas (Part VI) and bioartificial liver (Part VII). Finally, the application of tissue engineering to uses involving scaffold matrices for cartilage constructs, bone regeneration, immunoregulation, and gene therapy are discussed in Part VIII.

The editors would like to thank the members of the organizing committee of the symposium consisting of Todd Giorgio (Vanderbilt), Milton Harris (University of Alabama), Kiki Hellman (FDA), Jeffrey Hubbell (Caltech), Robert Langer (MIT), Alan Laskin (Engineering Foundation), Kenneth Luskey (Metabolex), Alvin Powers (Vanderbilt), Paul Kemp (Organogenesis), Anthony M. Sun (University of

xi

was due to the efforts of the chairpersons and the co-chairpersons of the different sessions: Jeffrey HubbeU, Milton Hams, T. K. Stevenson (Wichita State University), Buddy Ratner (University of Washington), Shalaby W. Shalaby (Poly-Med), Karel Ulbrich (Czech Academy of Sciences), Clark Colton (MIT), Robert Lanza (BioHy- brid Technologies), Alvin Powers, Wei-Shou Hu (University of Minnesota), Paul Kemp, Michael Caldwell (University of Minnesota), Gail Naughton (Advanced Tissue Sciences), and Athanassios Sambanis (GeorgiaTech).

A number of reviewers provided dedicated service to the publication of these proceedings. These reviewers put up with the demands of the editors and provided a rapid turnover of the manuscripts with the critical comments necessary for ensuring the quality of this publication. The editors are thankful to them for their effort. The reviewers are:

James D. Bryers, Montana State University, Bozeman, MT Riccardo Calafiore, Univ. Degli Studi Di Perugia, Perugia, Italy Paul Dubin, Indiana-Purdue University, Indianapolis, IN Kazumori Funatsu, Kyushu University, Fukuda, Japan Todd D. Giorgio, Vanderbilt University, Nashville, TN Jorge Heller, APS Research Institute, Redwood City, CA Ronald S. Hill, Neocrin, Irvine, CA Wei-Shou Hu, University of Minnesota, Minneapolis, MN Paul D. Kemp, Organogenesis, Canton, MA John Lake, UCSF, San Francisco, CA Robert Lanza, BioHybrid Technologies, Shrewsburry, MA Charles L. Linden, Jr., Walter Reed Army Institute, Washington, DC Hans Joerg Mathien, EPFL, Lausanne, Switzerland Tuoc Tuan Nguyen, EPFL, Lausanne, Switzerland Alvin C. Powers, Vanderbilt University, Nashville, TN David T. Rovee, Organogenesis, Canton, MA Athanassios Sambanis, Georgia Institute of Technology, Atlanta, GA Michael Sefton, University of Toronto, Toronto, Canada Ulrike Siebers, Justus-Liebig-Universitat, Giessen, Germany Karel Smetana, Jr., Charles University, Prague, Czech Republic William T. K. Stevenson, Wichita State University, Wichita, KS Anthony M. Sun, University of Toronto, Toronto, Canada Linda A. Tempelman, CytoTheraputics, Lincoln, RI Marcus Textor, ETH, Zurich, Switzerland Florence J. Wu, Advanced Tissue Sciences, La Jolla, CA Ioannis V. Yannas, MIT, Cambridge, MA

Finally, we would like to acknowledge the enormous contributions from the Engi- neering Foundation, particularly Charles Freiman, Barbara Hickernell, Alan Laskin and Donna McArdle.

The second conference of this series, BIO+AO 11, will be held in Banff, Alberta, Canada, in July 1998 with Professor David Hunkeler, EPFL, Lausanne, Switzerland as chairperson. The organizing committee consists of Alan Cherrington, Ales Pro- kop, Ray Rajotte, and Michael Sefton.