European academic faecal microbiota transplantation (EURFMT) network: improving the safety and quality of microbiome therapies in Europe
Faecal microbiota transplantation (FMT) has evolved from an anecdotally reported last resort for the critically ill to a well-established first-line treatment for patients with recurrent Clostridioides difficile infection (CDI), supported by grade 1a evidence. Given our improved understanding of the...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Verduci Editore
2023-11-01
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| Series: | Microbiota in Health and Disease |
| Subjects: | |
| Online Access: | https://www.microbiotajournal.com/wp-content/uploads/sites/7/2023/11/e954.pdf |
| _version_ | 1797368574777491456 |
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| author | C. Lodberg Hvas J. Keller S. Dahl Baunwall L. Edwards G. Ianiro J. Kupcinskas A. Link B. Mullish R. Satokari E. Terveer M. Vehreshild |
| author_facet | C. Lodberg Hvas J. Keller S. Dahl Baunwall L. Edwards G. Ianiro J. Kupcinskas A. Link B. Mullish R. Satokari E. Terveer M. Vehreshild |
| author_sort | C. Lodberg Hvas |
| collection | DOAJ |
| description | Faecal microbiota transplantation (FMT) has evolved from an anecdotally reported last resort for the critically ill to a well-established first-line treatment for patients with recurrent Clostridioides difficile infection (CDI), supported by grade 1a evidence. Given our improved understanding of the intestinal microbiota and how it impacts human health, FMT is now being explored for a range of emerging indications beyond CDI. In light of the rapid emergence of FMT as a novel treatment strategy in medicine, a need for international harmonisation has arisen. Addressing this need, the recently published 5th edition of the Guide to the quality and safety of tissues and cells for human application, issued by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM), harbours complete descriptions of the collection, procurement and application of donor faeces as a substance of human origin (SoHO). The proposed revision of the Blood Tissue and Cell Regulation of the European Union (EU) incorporates stool for FMT as a SoHO. This revised regulation will provide a regulatory framework for the future development of donor-derived microbiome therapies. To implement and underpin the safety and quality requirements for FMT in this newly designed legal context, and to facilitate clinical use, collaboration and research, we established the European Academic FMT Network (EurFMT network). The European FMT Registry plays a pivotal role within this network, facilitating its clinical activities and monitoring safety. In this document, we summarise the basis for using donor faeces-derived microbiome therapies as well as the aim and main scope for the EurFMT network. |
| first_indexed | 2024-03-08T17:34:30Z |
| format | Article |
| id | doaj.art-2cedc7f893a2444aa5f60facd09364fe |
| institution | Directory Open Access Journal |
| issn | 2704-8845 |
| language | English |
| last_indexed | 2024-03-08T17:34:30Z |
| publishDate | 2023-11-01 |
| publisher | Verduci Editore |
| record_format | Article |
| series | Microbiota in Health and Disease |
| spelling | doaj.art-2cedc7f893a2444aa5f60facd09364fe2024-01-02T13:19:18ZengVerduci EditoreMicrobiota in Health and Disease2704-88452023-11-01510.26355/mhd_202311_954954European academic faecal microbiota transplantation (EURFMT) network: improving the safety and quality of microbiome therapies in EuropeC. Lodberg Hvas0J. Keller1S. Dahl Baunwall2L. Edwards3G. Ianiro4J. Kupcinskas5A. Link6B. Mullish7R. Satokari8E. Terveer9M. Vehreshild10Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, DenmarkDepartment of Gastroenterology, Haaglanden Medical Center, The Hague, The NetherlandsDepartment of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, DenmarkCentre for Host Microbiome Interactions, Faculty of Dentistry, Oral & Craniofacial Sciences, Guy’s Hospital, King’s College London, London, United KingdomDepartment of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, ItalyDepartment of Gastroenterology and Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, LithuaniaDepartment of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University, Magdeburg, GermanyDivision of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, St Mary’s Hospital Campus, Imperial College London, London, United KingdomHuman Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, FinlandNetherlands Donor Feces Bank, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Internal Medicine II, Goethe University Frankfurt, University Hospital Frankfurt, Infectious Diseases, Frankfurt am Main, GermanyFaecal microbiota transplantation (FMT) has evolved from an anecdotally reported last resort for the critically ill to a well-established first-line treatment for patients with recurrent Clostridioides difficile infection (CDI), supported by grade 1a evidence. Given our improved understanding of the intestinal microbiota and how it impacts human health, FMT is now being explored for a range of emerging indications beyond CDI. In light of the rapid emergence of FMT as a novel treatment strategy in medicine, a need for international harmonisation has arisen. Addressing this need, the recently published 5th edition of the Guide to the quality and safety of tissues and cells for human application, issued by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM), harbours complete descriptions of the collection, procurement and application of donor faeces as a substance of human origin (SoHO). The proposed revision of the Blood Tissue and Cell Regulation of the European Union (EU) incorporates stool for FMT as a SoHO. This revised regulation will provide a regulatory framework for the future development of donor-derived microbiome therapies. To implement and underpin the safety and quality requirements for FMT in this newly designed legal context, and to facilitate clinical use, collaboration and research, we established the European Academic FMT Network (EurFMT network). The European FMT Registry plays a pivotal role within this network, facilitating its clinical activities and monitoring safety. In this document, we summarise the basis for using donor faeces-derived microbiome therapies as well as the aim and main scope for the EurFMT network.https://www.microbiotajournal.com/wp-content/uploads/sites/7/2023/11/e954.pdffecal microbiota transplantationregulationmicrobiometherapyintestinal diseases. |
| spellingShingle | C. Lodberg Hvas J. Keller S. Dahl Baunwall L. Edwards G. Ianiro J. Kupcinskas A. Link B. Mullish R. Satokari E. Terveer M. Vehreshild European academic faecal microbiota transplantation (EURFMT) network: improving the safety and quality of microbiome therapies in Europe Microbiota in Health and Disease fecal microbiota transplantation regulation microbiome therapy intestinal diseases. |
| title | European academic faecal microbiota transplantation (EURFMT) network: improving the safety and quality of microbiome therapies in Europe |
| title_full | European academic faecal microbiota transplantation (EURFMT) network: improving the safety and quality of microbiome therapies in Europe |
| title_fullStr | European academic faecal microbiota transplantation (EURFMT) network: improving the safety and quality of microbiome therapies in Europe |
| title_full_unstemmed | European academic faecal microbiota transplantation (EURFMT) network: improving the safety and quality of microbiome therapies in Europe |
| title_short | European academic faecal microbiota transplantation (EURFMT) network: improving the safety and quality of microbiome therapies in Europe |
| title_sort | european academic faecal microbiota transplantation eurfmt network improving the safety and quality of microbiome therapies in europe |
| topic | fecal microbiota transplantation regulation microbiome therapy intestinal diseases. |
| url | https://www.microbiotajournal.com/wp-content/uploads/sites/7/2023/11/e954.pdf |
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