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Guide to the quality and safety of tissues and cells for human application

What has changed in this 3rd Edition?

In this third edition, all chapters have been revised thoroughly to update their contents with the most recent advances in the field. In addition, many new and important chapters have been added.

  • In Part A, principles to be respected in new and developing therapies with cells or tissues for human application are introduced in the introductory chapter.
  • Chapter 2 on ‘Quality management, risk management and validation’ has been expanded to provide more specific guidance on the validation and qualification of premises, materials and technical procedures and methods.
  • General quality and safety aspects of processing and storage and quality aspects of premises now have separate dedicated chapters. In addition, the chapter on the principles of microbiological testing of tissue and cell preparations, introduced in the 2nd edition of the Guide, has been expanded.
  • The chapter on ‘Distribution and import/export’ of tissues and cells has been updated according to new EU Commission directives and requirements (as of April 2017) and a separate chapter on coding, labelling and packaging added. Due to its importance and requirement, traceability has its own dedicated chapter.
  • In Part B, chapters on specific tissues and cells have all been revised, updated and extended with additional information provided by experts from scientific and professional organisations, including the American Association of Tissue Banks (AATB), the European Association of Tissue Banks (EATB), the European Eye Bank Association (EEBA), the European Society for Human Reproduction and Embryology (ESHRE), the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee-ISCT & EBMT (JACIE). In particular, the chapter on haematopoietic progenitor cells has undergone a major review and revision, and the established use of pancreatic islets in the clinic justified a chapter of its own.
  • The previous ‘place holder’ on adipose tissue has been expanded into a full chapter providing complete guidance for its procurement, testing, storage and human application. Likewise, the chapter on fertility preservation is now a more complete chapter covering the state of the art on how and when fertility preservation may be useful.
  • In Part C, 'General considerations for cell-based therapies' provides a didactic overview of the field by describing the different ways in which cells can be expanded, modified or combined with scaffolds to replace damaged or diseased tissues in the recipient. This chapter includes information about the regulatory framework governing the production and use of some of these therapies in the EU.
  • 'Decellularisation and preparation of natural scaffolds' provides technical guidance to any tissue establishment in decellularisation techniques and the preparation and potential use of scaffolds.
  • 'Developing applications for somatic cells' focuses on developing applications for several types of cell that are rapidly becoming important tools for the treatment of patients. Specific issues in donor selection, procurement and testing (including testing for quality/specificity if applicable) are covered.
  • Finally, the last chapter updates information about several other substances obtained from humans for autologous or allogeneic use: human breast milk, faecal microbiota, teeth/dental pulp, platelet-rich plasma, platelet-rich fibrin and serum eye drops. This chapter provides a generic quality and safety framework for healthcare professionals treating patients with these substances.


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