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

What has changed in this 2nd Edition?

In this second edition, all of the 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.

  • The former chapter on identification of potential donors, consent and evaluation has been divided into two new, more comprehensive chapters: one on ‘Recruitment of potential donors’ and another one on ‘Donor evaluation’.
  • The chapter on ‘Donor testing’ now includes a detailed section that describes principles for validation of screening assays for infectious diseases used for testing blood from deceased donors, and considers differences in test results obtained by various types of testing laboratories (hospital-based versus reference laboratory).
  • The chapter on ‘Processing and storage’ has been updated to cover more detailed instructions on the requirements of processing facilities as well as monitoring of such facilities (viable and non-viable particles). The text has also been bolstered with more detailed information on the requirements of the cleaning of facilities, storage and exceptional release.
  • The chapters on ‘Distribution and import/export’ and on ‘Traceability’ now include the new EU requirements for the import and coding of tissues and cells.
  • The fields of assisted reproduction and fertility preservation are now addressed in detail in two dedicated chapters.
  • A very significant enhancement to the Guide has been the development of a new chapter dedicated to the principles of microbiological testing of tissue and cell preparations and their processing environments. This chapter recommends (among other features) the testing methods to be applied in the laboratory and outlines the principles that underpin validation of those methods.
  • As the fields of donation and transplantation of tissues and cells evolve, new and more sophisticated technologies provide opportunities to make tissues and cells safer, or their engraftment more effective. Hence, new chapters have been introduced in the Guide to address the field of cell therapy in particular. One of these new chapters 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. In a separate chapter, several types of cells (apart from haematopoietic stem cells) that are rapidly becoming important tools in the fight against disease are described.
  • A new chapter on adipose tissue has been added to provide general principles to be considered if banking adipose tissue, an activity that is showing promise for patients with scarring due to tumour removal or burns.
  • Finally, a new chapter introduces 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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