Creation of a fecal microbiota bank network in the Russian Federation

Fecal microbiota transplantation (FMT) is an effective and safe treat­ment for recurrent Clostridioides difficile infections. It is increasingly used to treat diseases pathogenetically associated with intestinal dysbiosis. Only 10% of the global demand for this treatment method is met. The growing popularity of this method necessitates the creation of fecal microbiota banks (FMBs), as they provide access to carefully screened fecal suspensions obtained from healthy donors. This review article analyzes approaches to FMB development, taking into account the legislative framework of the Russian Federation (RF), compared with regulations in North America, Europe, and the Asia-­Pacific region. Four following regulatory strategies for FMT are considered, defining the prospects for biobanking: 1) medicinal product; 2) biological pro­duct; 3) substance of human origin; 4) medical practice. Intro­ducing the approach practiced in the People's Republic of China (FMT as a medical practice) and the European Union (FMT as the use of a substance of human origin) in the Russian Federation is substantiated. The development of a FMB network will be facilitated by the national implementation of a standardized technology for collecting, processing donor material, storing, and dispensing the FMT product. Regional FMBs can be deployed at me­dical and research institutions, as well as at industrial pharmacies. Clinical and laboratory profiling of donors and recipients, including metagenomic analysis, in a national database will enable the creation of a system to support medical decision-­making and improve the efficacy and safety of FMT for the treatment of a wide range of pathologies. Developing a national FMB system will require coordinated efforts between specialized public organizations (with National Association of Biobanks and Biobanking Specialists (NASBIO)) and federal executive bodies, among which the Federal Medical and Biological Agency has the most experience with FMT and the necessary regulatory framework. A compelling advan­tage of deploying a national FMB network in Russia is the wide regional microbiome diversity, which allows for the identification of "superdonors" in conjunction with personalized FMT. The preconditions for accelerated advancement in the field of metagenomic regulation of human health have been created, and the FMB network is one of the tools for implementing this national breakthrough technology.

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