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Methods in Molecular Biology 1590 Jeremy M. Crook Editors Tenneille E. Ludwig Stem Cell Banking Concepts 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 Stem Cell Banking Concepts and Protocols Edited by Jeremy M. Crook ARC Centre of Excellence for Electromaterials Science, Intelligent Polymer Research Institute, AIIM Facility, Innovation Campus, University of Wollongong, Fairy Meadow, NSW, Australia Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, NSW, Australia Department of Surgery, St Vincent’s Hospital, The University of Melbourne, Fitzroy, VIC, Australia Tenneille E. Ludwig WiCell Research Institute, Madison, WI, USA Editors Jeremy M. Crook Tenneille E. Ludwig ARC Centre of Excellence for Electromaterials WiCell Research Institute Science Madison, WI, USA Intelligent Polymer Research Institute AIIM Facility, Innovation Campus University of Wollongong Fairy Meadow, NSW, Australia Illawarra Health and Medical Research Institute University of Wollongong Wollongong, NSW, Australia Department of Surgery St Vincent’s Hospital The University of Melbourne Fitzroy, VIC, Australia ISSN 1064-3745 ISSN 1940-6029 (electronic) Methods in Molecular Biology ISBN 978-1-4939-6919-7 ISBN 978-1-4939-6921-0 (eBook) DOI 10.1007/978-1-4939-6921-0 Library of Congress Control Number: 2017934046 © Springer Science+Business Media LLC 2017 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms 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 specific 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. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Printed on acid-free paper This Humana Press imprint is published by Springer Nature The registered company is Springer Science+Business Media LLC The registered company address is: 233 Spring Street, New York, NY 10013, U.S.A. Preface Stem cell banking has a critical role to play for supporting high quality research and transcend- ing the clinical potential of stem cells to actual medicine. Ideally, this is achieved by operating within a regulatory framework of good laboratory practice (GLP) or good manufacturing practice (GMP) for standardized, optimized, and controlled cell line production, storage, and distribution. Among other benefits, creating repositories of quality “seed stock” is a most immediate way to circumvent the problems associated with extended cell culture, including susceptibility to genetic and phenotypic drift during propagation, loss of cells due to cross- contamination with microorganisms or other cell lines, and stem cell differentiation. In recognizing the need for modern banking systems, major developed nations includ- ing the US, UK, and Japan have invested significantly in stem cell banking to prepare for the next major phase in researching and commercializing stem cells and producing clinical treatments. Importantly, stem cell banking need not entail setting up large and expensive stand- alone facilities that operate on a national or international scale, but can involve smaller ini- tiatives to support the activities of individual universities, research institutes, or laboratories. Whatever the scale, a bank should align with global “best practice” for handling stem cells, ideally endorsed by leading stem cell organizations, networks, and consortia around the world. Moreover, a bank should ensure the management and distribution of cell lines in the most efficient and cost-effective way. For example, the succession of commercial and clinical aspirations could be facilitated by having low-cost quality-controlled GLP cells for research that are also available as more expensive clinical-grade GMP lines. In addition, research and clinical-grade variants of the same cell lines/banks will provide consistency between labora- tory and clinical activities for more predictable and better translational application. Given the recent upsurge in stem cell research and development (R&D), including technological breakthroughs in creating new types of stem cells such as induced pluripotent stem cells (iPSCs), as well as clinical trials of human stem cell-based therapies, the publica- tion of this book on Stem Cell Banking is timely. This volume brings together contributions from experts in the field to guide stem cell banking, and in turn champion quality stem cell R&D and facilitate the translation of stem cells to clinical practice. The book covers concepts and protocols relating to the banking of both pluripotent and somatic stem cells, from the ethical procurement of tissues and cells for the provision of “seed stock,” standardized methods for deriving hESCs and iPSCs, isolating mesenchymal stem cells, cell culture and cryopreservation, in addition to quality assurance (including cell line characterization) and information management. As a volume in the highly successful Methods in Molecular Biology™ series, it aims to contribute to the development of competence in the subject by providing advice that is crucial to establishing a bona fide stem cell bank. By proffering Stem Cell Banking, we hope to strengthen and maximize the use of existing and future stem cell resources. Finally, the volume should serve as a valuable resource for established stem cell scientists and those new to the field. Wollongong, NSW, Australia Jeremy M. Crook v Contents Preface.......................................................... v Contributors.......................................................... ix P I G T S C B ART ENERIC HEMES IN TEM ELL ANKING 1 Stem Cell Banking: A Global View ................................. 3 Glyn Stacey 2 Quality Assurance in Stem Cell Banking: Emphasis on Embryonic and Induced Pluripotent Stem Cell Banking .......................... 11 Therése Kallur, Pontus Blomberg, Sonya Stenfelt, Kristian Tryggvason, and Outi Hovatta 3 Acquisition and Reception of Primary Tissues, Cells, or Other Biological Specimens .................................... 17 Lyn E. Healy 4 Information Management........................................ 29 Alberto Labarga, Izaskun Beloqui, and Angel G. Martin 5 Cryopreservation: Vitrification and Controlled Rate Cooling.............. 41 Charles J. Hunt 6 Quality Assured Characterization of Stem Cells for Safety in Banking for Clinical Application.......................................... 79 Kevin W. Bruce, John D.M. Campbell, and Paul De Sousa 7 Ethics and Governance of Stem Cell Banks ........................... 99 Donald Chalmers, Peter Rathjen, Joy Rathjen, and Dianne Nicol P II P P S C B ART ROTOCOLS FOR LURIPOTENT TEM ELL ANKING 8 Derivation of Human Embryonic Stem Cells.......................... 115 Jeremy M. Crook, Lucy Kravets, Teija Peura, and Meri T. Firpo 9 Derivation of Human-Induced Pluripotent Stem Cells in Chemically Defined Medium............................................... 131 Guokai Chen and Mahendra Rao 10 Culture, Adaptation, and Expansion of Pluripotent Stem Cells ............ 139 Jennifer L. Brehm and Tenneille E. Ludwig 11 Cryobanking Pluripotent Stem Cells................................ 151 Jeremy M. Crook, Eva Tomaskovic-Crook, and Tenneille E. Ludwig 12 Genome Editing in Human Pluripotent Stem Cells..................... 165 Jared Carlson-Stevermer and Krishanu Saha vii viii Contents P III P M S C B ART ROTOCOLS FOR ESENCHYMAL TEM ELL ANKING 13 Isolation, Culture, and Expansion of Mesenchymal Stem Cells ............ 177 Izaskun Ferrin, Izaskun Beloqui, Lorea Zabaleta, Juan M. Salcedo, Cesar Trigueros, and Angel G. Martin 14 Cryobanking Mesenchymal Stem Cells .............................. 191 Andrés Pavón, Izaskun Beloqui, Juan M. Salcedo, and Angel G. Martin P IV P H N S C B ART ROTOCOLS FOR UMAN EURAL TEM ELL ANKING 15 Culturing and Cryobanking Human Neural Stem Cells.................. 199 Jeremy M. Crook and Eva Tomaskovic-Crook Index ............................................................... 207 Contributors IZASKUN BELOQUI • StemTek Therapeutics, Derio, Spain PONTUS BLOMBERG • Vecura, Karolinska University Hospital, Stockholm, Sweden JENNIFER L. BREHM • WiCell Research Institute, Madison, WI, USA KEVIN W. BRUCE • Censo Biotechnologies Ltd and Roslin Cell Sciences Ltd, Midlothian, UK JOHN D.M. CAMPBELL • Scottish Blood Transfusion Service, Edinburgh, UK JARED CARLSON-STEVERMER • Department of Biomedical Engineering, University of Wisconsin-Madison, Madison, WI, USA; Wisconsin Institute for Discovery, University of Wisconsin-Madison, Madison, WI, USA DONALD CHALMERS • Centre for Law and Genetics, Faculty of Law, University of Tasmania, Hobart, TAS, Australia GUOKAI CHEN • Faculty of Health Sciences, University of Macau, Taipa, Macau, China; Center for Molecular Medicine, National Heart, Lung and Blood Institute, Bethesda, MD, USA JEREMY M. CROOK • ARC Centre of Excellence for Electromaterials Science, Intelligent Polymer Research Institute, AIIM Facility, Innovation Campus, University of Wollongong, Fairy Meadow, NSW, Australia; Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, NSW, Australia; Department of Surgery, St Vincent’s Hospital, The University of Melbourne, Fitzroy, VIC, Australia IZASKUN FERRIN • StemTek Therapeutics, Derio, Spain MERI T. FIRPO • Division of Endocrinology and Stem Cell Institute, Department of Medicine, McGuire Translational Research Facility, University of Minnesota, Minneapolis, MN, USA LYN E. HEALY • The Francis Crick Institute, London, UK OUTI HOVATTA • CLINTEC, Karolinska Institute, Flemingsberg, Sweden CHARLES J. HUNT • UK Stem Cell Bank, National Institute for Biological Standards and Control, Hertfordshire, UK THERÉSE KALLUR • BioLamina, Stockholm, Sweden LUCY KRAVETS • Centre for Blood Cell Therapies, Peter MacCallum Cancer Centre, East Melbourne, Australia ALBERTO LABARGA • Department of Computer Science and Artificial Intelligence, University of Granada, Gardana, Spain TENNEILLE E. LUDWIG • WiCell Research Institute, Madison, WI, USA ANGEL G. MARTIN • StemTek Therapeutics, Derio, Spain DIANNE NICOL • Centre for Law and Genetics, Faculty of Law, University of Tasmania, Hobart, TAS, Australia ANDRÉS PAVÓN • StemTek Therapeutics, Derio, Spain TEIJA PEURA • Genea Biomedx, Sydney, NSW, Australia MAHENDRA RAO • New York Stem Cell Foundation Research Institute, New York, NY, USA; Q Therapeutics, Salt Lake City, UT, USA; Wake Forest Institute for Regenerative Medicine, Wake Forest University, Winston-Salem, NC, USA ix x Contributors JOY RATHJEN • School of Medicine, University of Tasmania, Hobart, TAS, Australia PETER RATHJEN • The Menzies Institute of Medical Research, University of Tasmania, Hobart, TAS, Australia KRISHANU SAHA • Department of Biomedical Engineering, University of Wisconsin-M adison, Madison, WI, USA; Wisconsin Institute for Discovery, University of Wisconsin-Madison, Madison, WI, USA JUAN M. SALCEDO • StemTek Therapeutics, Derio, Spain PAUL DE SOUSA • Roslin Cell Sciences Ltd., Midlothian, UK; Censo Biotechnologies Ltd., Midlothian, UK; Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK GLYN STACEY • UK Stem Cell Bank, National Institute for Biological Standards and Control, Hertfordshire, UK SONYA STENFELT • Department of Neuroscience, Uppsala University, Uppsala, Sweden EVA TOMASKOVIC-CROOK • AIIM Facility, ARC Centre of Excellence for Electromaterials Science, Intelligent Polymer Research Institute, University of Wollongong, Fairy Meadow, NSW, Australia; Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, NSW, Australia CESAR TRIGUEROS • StemTek Therapeutics, Derio, Spain KRISTIAN TRYGGVASON • BioLamina, Stockholm, Sweden LOREA ZABALETA • StemTek Therapeutics, Derio, Spain Part I Generic Themes in Stem Cell Banking

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