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Methods in Molecular Biology 1479 Emmanuel C. Opara Editor Cell Micro- encapsulation Methods and Protocols M M B ETHODS IN OLECULAR IOLOGY Series Editor John M. Walker School of Life and Medical Sciences University of Hertfordshire Hatfield, Hertfordshire, AL10 9AB , UK For further volumes: http://www.springer.com/series/7651 Cell Microencapsulation Methods and Protocols Edited by Emmanuel C. Opara Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA; Virginia Tech-Wake Forest School of Biomedical, Engineering & Sciences (SBES), Wake Forest School of Medicine, Winston-Salem, NC, USA Editor Emmanuel C. Opara Wake Forest Institute for Regenerative Medicine Wake Forest School of Medicine Winston-Salem, NC, USA Virginia Tech-Wake Forest School of Biomedical Engineering & Sciences (SBES) Wake Forest School of Medicine Winston-Salem, NC, USA ISSN 1064-3745 ISSN 1940-6029 (electronic) Methods in Molecular Biology ISBN 978-1-4939-6362-1 ISBN 978-1-4939-6364-5 (eBook) DOI 10.1007/978-1-4939-6364-5 Library of Congress Control Number: 2016951446 © Springer Science+Business Media New York 2 017 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifi cally the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfi lms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specifi c statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper This Humana Press imprint is published by Springer Nature The registered company is Springer Science+Business Media LLC New York Prefa ce The technique of microencapsulation was introduced approximately eight decades ago, and its potential application in cell therapy was described almost 50 years later. The technique offers a wide range of applications in both industry and medicine. Cell microencapsulation comes under the broader fi eld of bioencapsulation and in most cases involves the immobi- lization of therapeutic cells in polymeric scaffolds or semipermeable hydrogel capsules that provide the cells with a favorable protective environment allowing the exchange of nutri- ents and oxygen and protecting them from the host’s immune system by blocking the entry of antibodies and cytotoxic immune cells. Thus, the technology has been widely used in various efforts to develop transplantable bioartifi cial organs without the need to immuno- suppress transplant recipients, to expand donor cell sources, and in cancer cell therapy. More recently, this technique has received attention for applications in stem cell therapy, and the encapsulation of bacterial cells and other cell types for drug delivery. In stem cell therapy, cell microencapsulation has the potential to be used for the restriction of migratory mesenchymal stromal cells within a defective target tissue/organ to induce tissue repair. The purpose of this book is to provide a unique forum to review the promise of cell microencapsulation in a broad sense that encompasses various cell types that have been encapsulated for different purposes, the different approaches/devices used for microencapsulation, the biomaterials used in cell microencapsulation, the challenges to the technology, and the current status of its application in different clinical situations. To achieve this purpose, the book is divided into fi ve parts. Part I is the introductory part of the book that discusses historical developments of the technology and the current challenges facing it, as well as the various applications of cell microencapsulation. Part II discusses the main approaches and devices currently used in cell microencapsulation while Part III presents an overview of the various polymeric materials currently in use for cell microencapsulation, procedures for assessment of the quality of microcapsules used for cell encapsulation, and the enabling technologies to either monitor or enhance encapsulated cell function. In Part IV, specifi c examples of the methods used to encapsulate various cell types are discussed while Part V provides an overview of the different clinical situations in which cell microencapsulation has been applied. Cell Microencapsulation is intended to be a reference handbook for researchers, engineers, clinicians, and other health-care professionals, as well as food technologists, who will fi nd in the book detailed descriptions of methods for the microencapsulation of specifi c cell types and their current or potential clinical and industrial applications. The book also includes detailed information about the design and manufacture of different devices including large-scale production devices for use in cell microencapsulation. Furthermore, individuals or family members of individuals affl icted with certain diseases for which cell microencapsulation has potential application will fi nd the book to be a good source of information as they research new therapeutic options in cell therapy for those disease states. In addition, entrepreneurs/investors and the scientists that work with them in Biotechnology will fi nd this book to be a great resource for assessment of the promise of the cell microencapsulation technology to enable them make informed decisions about where to make rewarding investments. v vi Preface I would like to express my sincere gratitude to certain individuals with whom I have interacted personally since I have been working on the microencapsulation technology. First, I would like to thank Dr. Gerrit H. J. Wolters, formerly of the University of Groningen, Groningen, The Netherlands, who provided me with a copy of his published article on the instrumentation for the air-syringe-pump droplet generator that enabled my research team at the Duke University Medical Center to build our fi rst apparatus for cell microencapsulation in 1995. The key members of that research team who worked with the gifted engineers and technicians at the Duke Instrument Shop to build that fi rst device were Marc R. Garfi nkel, M.D., and Robert C. Harland, M.D., to whom I am greatly indebted. The contributions of some of my former students and fellows at Duke, most notably, William F. Kendall Jr., M.D., and Marcus D. Darrabie, M.D., to the development and perfection of the technique in my lab at Duke deserve my eternal gratitude. I am also indebted to my long-term collaborator, Dr. M.K. Ramasubramanian, the D.W. Reynolds Distinguished Professor and Department Chair, Department of Mechanical Engineering at Clemson University in South Carolina, USA, and two former students, Dr. Sameer Tendulkar and Dr. John Patrick McQuilling, who worked with us on the fi rst generation of our microfl u- idic devices for cell microencapsulation. In addition, I am deeply grateful to Dr. Joel Stitzel, Professor and Chair of Biomedical Engineering at the Wake Forest School of Medicine, for offering me the opportunity to serve as the Graduate Program Director at the Wake Forest campus of the joint Virginia Tech-Wake Forest School of Biomedical Engineering & Sciences (SBES), and for providing me what has turned out to be the best working relation- ship experience of my entire academic career. In addition, I appreciate immensely the moral support of some friends, including Engr. and Mrs. Ben Akah, Dr. and. Mrs. Nnaemeka J. Ojukwu, Dr. and. Mrs. Obiora Ogbuawa, and Rev. Dr. Donatus N. Nwachukwu, as it has been a continuous source of inspiration in my career. Finally, I would like to acknowledge the great patience, personal sacrifi ce, and unquali- fi ed support of my lovely wife, Clarice, and our children, Ogechi, Chiedu, Chucky, and Ike, in my career. I am grateful to each and every one of them for giving me the luxury of long periods of absence from home as I vigorously pursued my research efforts. For their support, I would like to dedicate this book to all my family and my lifelong mentor, Vay Liang W. Go, M.D., currently Distinguished University Professor of Medicine and Director, UCLA Center for Excellence in Pancreatic Diseases, who gave me the opportunity to work with him at the National Institutes of Health, Bethesda, Maryland, where I started my research in islet biology that set the stage for the development of my interest and expertise in cell microencapsulation. Winston-Salem, NC Emmanuel C. Opara Contents Preface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v Contributors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x i PART I INTRODUCTION 1 H istorical Perspectives and Current Challenges in Cell Microencapsulation. . . 3 Paul de Vos 2 A pplications of Cell Microencapsulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3 Emmanuel C. Opara PART II APPROACHES TO CELL MICROENCAPSULATION 3 C ell Microencapsulation: Dripping Methods. . . . . . . . . . . . . . . . . . . . . . . . . . 43 A. Bidoret , E . Martins , B . Poncelet De Smet , and D. Poncelet 4 F ield Effect Microparticle Generation for Cell Microencapsulation . . . . . . . . . 5 7 Brend Ray-Sea Hsu and Shin-Huei Fu 5 M icrofluidic Approach to Cell Microencapsulation . . . . . . . . . . . . . . . . . . . . . 7 1 Varna Sharma , M ichael Hunckler , M elur K. Ramasubramanian , Emmanuel C. Opara , and Kalyan C. Katuri PART III BIOMATERIALS AND ENABLING TECHNOLOGIES IN CELL MICROENCAPSULATION 6 P olymeric Materials for Cell Microencapsulation. . . . . . . . . . . . . . . . . . . . . . . 7 9 A. Aijaz , D . Perera , and Ronke M. Olabisi 7 P olymeric Materials for Perm-Selective Coating of Alginate Microbeads . . . . . 9 5 William F. Kendall Jr. and Emmanuel C. Opara 8 D etermination of the Mechanical Strength of Microcapsules. . . . . . . . . . . . . . 1 11 Marcus D. Darabbie and Emmanuel C. Opara 9 T he Diffusive Properties of Hydrogel Microcapsules for Cell Encapsulation. . . 119 D. M. Lavin , B . E. Bintz , and C. G. Thanos 10 M ethods for Incorporating Oxygen-Generating Biomaterials into Cell Culture and Microcapsule Systems . . . . . . . . . . . . . . . . . . . . . . . . . . 135 John Patrick McQuilling and Emmanuel C. Opara 1 1 N oninvasive Tracking of Alginate-Microencapsulated Cells . . . . . . . . . . . . . . . 1 43 Genaro A. Paredes-Juarez , B rad P. Barnett , and Jeff W. M. Bulte 12 R etrieval of Microencapsulated Islet Grafts for Post-t ransplant Evaluation. . . . 1 57 John Patrick McQuilling , S ivanandane Sittadjody , R ajesh Pareta , Samuel Pendergraft , C lancy J. Clark , A lan C. Farney , and Emmanuel C. Opara vii viii Contents PART IV ISOLATION OF CELLS FOR MICROENCAPSULATION 13 A Method of Porcine Pancreatic Islet Isolation for Microencapsulation . . . . . . 1 75 William F. Kendall Jr. and Emmanuel C. Opara 14 S elective Osmotic Shock (SOS)-Based Islet Isolation for Microencapsulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191 Kevin Enck , J ohn Patrick McQuilling , G iuseppe Orlando , Riccardo Tamburrini , S ittadjody Sivanandane , and Emmanuel C. Opara 15 P reparation and Characterization of Alginate–Chitosan Microcapsule for Hepatocyte Culture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199 Lanjuan Li , Y anhong Zhang , and Xiaoping Pan 16 U se of Flow Focusing Technique for Microencapsulation of Myoblasts . . . . . . 2 07 J. Ciriza , L . Saenz del Burgo , R . M . Hernández , G . Orive , and J. L . Pedraz 17 A lginate Microbeads for Cell and Protein Delivery . . . . . . . . . . . . . . . . . . . . . 2 17 Sami I. Somo , O maditya Khanna , and Eric M. Brey 18 C ompartmentalization of Two Cell Types in Multilayered Alginate Microcapsules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 25 Sivanandane Sittadjody , J ustin M. Saul , and Emmanuel C. Opara 19 P rimary Choroid Plexus Tissue for Use in Cellular Therapy. . . . . . . . . . . . . . . 2 37 M. A . Sandrof, D.F. Emerich, and Chris G. Thanos 20 M icroencapsulation of Stem Cells for Therapy. . . . . . . . . . . . . . . . . . . . . . . . . 2 51 Shirae K. Leslie , R amsey C. Kinney , Z vi Schwartz , and Barbara D. Boyan 21 M icroencapsulated Cells for Cancer Therapy. . . . . . . . . . . . . . . . . . . . . . . . . . 2 61 L. Saenz del Burgo , J . Ciriza , R . M . Hernández , G . Orive , and J. L . Pedraz 22 M icroencapsulation of Bacterial Cells by Emulsion Technique for Probiotic Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273 Surajit Mandal and Subrota Hati PART V CELL MICROENCAPSULATION IN CLINICAL APPLICATIONS 23 M icroencapsulation of Islets for the Treatment of Type 1 Diabetes Mellitus (T1D). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283 Riccardo Calafiore , G iuseppe Basta , and Pia Montanucci 24 I mmunological Challenges Facing Translation of Alginate Encapsulated Porcine Islet Xenotransplantation to Human Clinical Trials. . . . . . . . . . . . . . . 305 Rahul Krishnan , D avid Ko , C larence E. Foster III , W endy Liu , A . M . Smink , Bart de Haan , P aul De Vos , and Jonathan R. T . Lakey 25 M icroencapsulation in Clinical Islet Xenotransplantation. . . . . . . . . . . . . . . . . 3 35 Masayuki Shimoda and Shinichi Matsumoto Contents ix 26 M ethods for Microencapsulated Porcine Islet Production . . . . . . . . . . . . . . . . 3 47 Masayuki Shimoda and Shinichi Matsumoto 27 M icroencapsulation of Parathyroid Cells for the Treatment of Hypoparathyroidism. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 357 Patricio Cabané Toledo , R icardo L. Rossi , and Pablo Caviedes Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 65