de Stefano Maria Chiara, Mazzanti Benedetta, Vespasiano Francesca, Lombardini Letizia, Cardillo Massimo
Italian National Transplant Centre, Istituto Superiore di Sanità, 00161 Rome, Italy.
Antibiotics (Basel). 2022 Apr 5;11(4):480. doi: 10.3390/antibiotics11040480.
Faecal microbiota transplantation (FMT) is regarded as an efficacious treatment for recurrent 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 management, especially through extensive high-quality donor selection and full traceability maintenance.
粪便微生物群移植（FMT）被视为复发性感染的一种有效治疗方法。不幸的是，监管障碍阻碍了患者的广泛使用，这些障碍是将FMT纳入临床实践的主要障碍。在欧洲和国际层面，对于FMT的分类没有统一的观点，需要共同努力来解决这一监管难题。在本交流中，我们报告了意大利FMT应用的监管原则和实施方法。我们的经验表明，欧盟组织和细胞指令适合确保FMT管理的安全和高效，特别是通过广泛的高质量供体选择和全面的可追溯性维护。
