Human tissues and cells are used in an increasing variety of ways, from advances in transplantation therapy to medically assisted reproduction. All these techniques have enormous therapeutic benefits for patients or, in some cases, may be the only viable treatment for reclaiming essential functions, for example by restoring patients’ sight or helping them regain mobility. Remarkably, some of these therapies can be also used to help citizens to fulfil their wish to become parents.

Tissues and cells (such as corneas, cardiovascular tissues, bones, tendons, skin, amniotic membrane, gametes, hematopoietic stem cells and other cells) from deceased or living donors help improve the quality of life and save the lives of patients threatened by serious medical conditions. However, the application of these valuable human substances raises many important questions in terms of their safety and quality, and of ethical standards. 

The updated 5th edition of the Guide to the quality and safety of tissues and cells for human application provides a comprehensive overview of the most recent advances in the field, and technical guidance to ensure the appropriate quality and safety of tissues and cells for human use. It is intended to provide practical support to professionals involved in all stages in the handling and treatment of tissues and cells, starting from identifying potential donors to clinical application in patients and their follow-up, including:

  • professionals involved in identifying potential donors,
  • transplant co-ordinators managing the process of donation after death,
  • bone marrow and cord blood collection centres,
  • fertility clinics,
  • tissue establishments processing and storing tissues and cells,
  • testing laboratories,
  • organisations responsible for human application,
  • inspectors auditing the establishments,
  • health authorities for tissues and cells for human application.

Download the leaflet for more details on the 5th edition of the Guide to the quality and safety of tissues and cells for human application.

The electronic version of the guide can be downloaded for free online.

The paper version is available for purchase at the EDQM Store.