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The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for Clostridioides difficile Infection in Italy
Faecal microbiota transplantation (FMT) is regarded as an efficacious treatment for recurrent C. difficile infection. Unfortunately, widespread patient access is hindered by regulatory hurdles, which are the primary barriers to incorporating FMT into clinical practice. At the European and Internatio...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9024936/ https://www.ncbi.nlm.nih.gov/pubmed/35453231 http://dx.doi.org/10.3390/antibiotics11040480 |
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author | de Stefano, Maria Chiara Mazzanti, Benedetta Vespasiano, Francesca Lombardini, Letizia Cardillo, Massimo |
author_facet | de Stefano, Maria Chiara Mazzanti, Benedetta Vespasiano, Francesca Lombardini, Letizia Cardillo, Massimo |
author_sort | de Stefano, Maria Chiara |
collection | PubMed |
description | Faecal microbiota transplantation (FMT) is regarded as an efficacious treatment for recurrent C. difficile infection. Unfortunately, widespread patient access is hindered by regulatory hurdles, which are the primary barriers to incorporating FMT into clinical practice. At the European and International level, there is no uniform perspective on FMT classification, and a coordinated effort is desirable to solve this regulatory puzzle. In this communication, we report the regulatory principles and the implementation approach for FMT application in Italy. Our experience suggests that the EU Tissue and Cell Directives are suited to ensure safe and efficient FMT for C. difficile management, especially through extensive high-quality donor selection and full traceability maintenance. |
format | Online Article Text |
id | pubmed-9024936 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-90249362022-04-23 The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for Clostridioides difficile Infection in Italy de Stefano, Maria Chiara Mazzanti, Benedetta Vespasiano, Francesca Lombardini, Letizia Cardillo, Massimo Antibiotics (Basel) Communication Faecal microbiota transplantation (FMT) is regarded as an efficacious treatment for recurrent C. difficile infection. Unfortunately, widespread patient access is hindered by regulatory hurdles, which are the primary barriers to incorporating FMT into clinical practice. At the European and International level, there is no uniform perspective on FMT classification, and a coordinated effort is desirable to solve this regulatory puzzle. In this communication, we report the regulatory principles and the implementation approach for FMT application in Italy. Our experience suggests that the EU Tissue and Cell Directives are suited to ensure safe and efficient FMT for C. difficile management, especially through extensive high-quality donor selection and full traceability maintenance. MDPI 2022-04-05 /pmc/articles/PMC9024936/ /pubmed/35453231 http://dx.doi.org/10.3390/antibiotics11040480 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Communication de Stefano, Maria Chiara Mazzanti, Benedetta Vespasiano, Francesca Lombardini, Letizia Cardillo, Massimo The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for Clostridioides difficile Infection in Italy |
title | The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for Clostridioides difficile Infection in Italy |
title_full | The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for Clostridioides difficile Infection in Italy |
title_fullStr | The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for Clostridioides difficile Infection in Italy |
title_full_unstemmed | The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for Clostridioides difficile Infection in Italy |
title_short | The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for Clostridioides difficile Infection in Italy |
title_sort | regulatory approach for faecal microbiota transplantation as treatment for clostridioides difficile infection in italy |
topic | Communication |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9024936/ https://www.ncbi.nlm.nih.gov/pubmed/35453231 http://dx.doi.org/10.3390/antibiotics11040480 |
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