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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...

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Autores principales: de Stefano, Maria Chiara, Mazzanti, Benedetta, Vespasiano, Francesca, Lombardini, Letizia, Cardillo, Massimo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
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.
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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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