Developments in tissue engineered and regenerative medicine products a practical approach

Developments in tissue engineered and regenerative medicine products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Features of current cell therapy and tissue engineered products which have facilitated su...

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Bibliographic Details
Main Authors: Basu, Joydeep, Ludlow, John W. (Author)
Format: eBook
Language:English
Published: Cambridge Woodhead Pub. 2012
Series:Woodhead Publishing series in biomaterials
Subjects:
Online Access:
Collection: O'Reilly - Collection details see MPG.ReNa
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100 1 |a Basu, Joydeep 
245 0 0 |a Developments in tissue engineered and regenerative medicine products  |b a practical approach  |c Joydeep Basu and John W. Ludlow 
260 |a Cambridge  |b Woodhead Pub.  |c 2012 
300 |a xvii, 204 pages  |b illustrations 
505 0 |a Includes bibliographical references and index 
505 0 |a 3.6 Selection of biomaterials for tubular organs: bladder, esophagus and small intestineReferences; 4 Neo-Bladder: a foundational technology platform for tubular organ regeneration; 4.1 The need for urinary neo-organs; 4.2 TE/RM methodologies for bladder replacement and augmentation; 4.3 Demonstration of Neo-Bladder formation in large animals; 4.4 Can neo-bladder constructs be made from cells sourced from diseased patients?; 4.5 Neo-bladder replacement in human pediatric patients -- first clinical trials of a neo-organ; 4.6 Making the product: cell sourcing 
505 0 |a 5.8 Regeneration of muco-cutaneous region at the skin/conduit junction5.9 Speculations for the future; References; 6 Tissue engineering of non-bladder tubular organs; 6.1 Introduction; 6.2 Vasculature; 6.3 Lung; 6.4 Gastrointestinal tract; 6.5 Genito-urinary system; References; 7 Tissue engineering of solid organs; 7.1 Introduction; 7.2 Kidney; 7.3 Heart; 7.4 Liver; 7.5 Pancreas; 7.6 Spleen; 7.7 Central nervous system; 7.8 Summary; References; 8 Regulatory and quality control; 8.1 Good manufacturing practice; 8.2 Good tissue practices 
505 0 |a 4.7 Definition of the cell source used for seeding neo-bladders: adipose4.8 Other approaches to tissue engineering neo-bladders; 4.9 Key results from development of the Neo-Bladder: factors facilitating commercial viability of an organ regeneration platform; References; 5 Neo-Urinary ConduitTM; 5.1 Introduction; 5.2 Assembly of the NUC; 5.3 Preclinical evaluation of the NUC; 5.4 Assembly of an NUC cell/scaffold composite; 5.5 GLP preclinical analysis of de novo NUC formation in a porcine cystectomy model; 5.6 Alternate cell sourcing of SMC for seeding of the NUC; 5.7 Clinical trials of the NUC. 
505 0 |a 2.4 Development of genome modification technologies: gene-based cell therapies2.5 Committed cell types: ideal candidates for TE/RM product development; 2.6 Summary: key features favoring commercial development of cellular ABIs; References; 3 Biomaterials for TE/RM products; 3.1 Introduction; 3.2 The ECM: comparator for biomaterials; 3.3 Decell/recell: the ultimate biomaterial platform?; 3.4 Selection of biomaterials for tissue engineering: illustrative example -- kidney; 3.5 Biomaterials candidates for renal tissue engineering 
505 0 |a Cover; Dedication; Developments in tissue engineered and regenerative medicine products: A practical approach; Copyright; Contents; List of figures, tables and boxes; About the authors; Woodhead Publishing Series in Biomaterials; Preface; Acknowledgements; 1 Overview of tissue engineering/ regenerative medicine; 1.1 Introduction; 1.2 Cells; 1.3 Biomaterials; 1.4 Therapeutic product delivery; References; 2 Cells; 2.1 Introduction; 2.2 Mechanism of action of cell-based therapeutics; 2.3 Other stem cell-based therapeutics currently under development 
653 |a MEDICAL / Osteopathy / bisacsh 
653 |a HEALTH & FITNESS / Holism / bisacsh 
653 |a Regenerative medicine / http://id.loc.gov/authorities/subjects/sh2008001685 
653 |a Tissue Engineering 
653 |a Tissue engineering / fast 
653 |a MEDICAL / Alternative Medicine / bisacsh 
653 |a Génie tissulaire 
653 |a Médecine régénératrice 
653 |a MEDICAL / Essays / bisacsh 
653 |a MEDICAL / Atlases / bisacsh 
653 |a Regenerative Medicine 
653 |a MEDICAL / Family & General Practice / bisacsh 
653 |a Regenerative medicine / fast 
653 |a MEDICAL / Holistic Medicine / bisacsh 
653 |a Tissue engineering / http://id.loc.gov/authorities/subjects/sh2003001133 
653 |a HEALTH & FITNESS / Reference / bisacsh 
700 1 |a Ludlow, John W.  |e author 
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520 |a Developments in tissue engineered and regenerative medicine products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Features of current cell therapy and tissue engineered products which have facilitated successful commercialization are emphasized and roadblocks to successful product development are also highlighted. Preclinical and clinical testing of tissue engineered and regenerative medicine products, regulatory, quality control, manufacturing issues, as well as generating and securing intellectual property and freedom to operate considerations are presented. This book represents a complete 'how-to' manual for the development of tissue engineered and regenerative medicine products from conceptualization to clinical trial to manufacturing. Addresses practical considerations for the field of tissue engineering and regenerative medicine from the perspective of the biotechnology industryWritten as a manual for tissue engineering and regenerative medicine product development applicable to the US and EUIllustrates pathway integration of science and business required for successful product development