Evolution of FMT - From early clinical to standardized treatments

Stephanie L Servetas; Phillip J Daschner; Cyril Guyard; Vincent Thomas; Herve Affagard; Chrysi Sergaki; Harry Sokol; Jennifer A Wargo; Gary D Wu; Philippe Sabot

doi:10.1016/j.biologicals.2022.01.004

Evolution of FMT - From early clinical to standardized treatments

Biologicals. 2022 Apr:76:31-35. doi: 10.1016/j.biologicals.2022.01.004. Epub 2022 Jan 24.

Authors

Affiliations

¹ Complex Microbial Systems Group, Biosystems and Biomaterials Divison, National Institute of Standards and Technology, Gaithersburg, MD, USA. Electronic address: stephanie.servetas@nist.gov.
² Division of Cancer Biology, National Cancer Institute, Bethesda, MD, USA. Electronic address: daschnep@mail.nih.gov.
³ BIOASTER Technological Research Institute, Lyon, France. Electronic address: Cyril.GUYARD@bioaster.org.
⁴ BIOASTER Technological Research Institute, Lyon, France. Electronic address: Vincent.THOMAS@bioaster.org.
⁵ MaaT Pharma, 70 Avenue Tony Garnier, 69007, Lyon, France. Electronic address: haffagard@maat-pharma.com.
⁶ Microbiome Section, National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, EN6 3QG, United Kingdom. Electronic address: Chrysi.Sergaki@nibsc.org.
⁷ Assistance Publique des Hôpitaux de Paris, Saint-Antoine Hospital, Gastroenterology Department, 184 rue du faubourg Saint-Antoine 75571 Paris cedex 12, France. Electronic address: harry.sokol@aphp.fr.
⁸ Departments of Surgical Oncology and Genomic Medicine, the University of Texas, MD Anderson Cancer Center, Houston, TX, USA. Electronic address: JWargo@mdanderson.org.
⁹ Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: gdwu@pennmedicine.upenn.edu.
¹⁰ International Alliance for Biological Standardization, IABS, Geneva, Switzerland. Electronic address: philippe.sabot@iabs.org.

PMID: 35086768
DOI: 10.1016/j.biologicals.2022.01.004

Abstract

Faecal microbiota transplantation (FMT) is widely reported to be an effective treatment against recurrent Clostridioides difficile infections. Recent clinical studies support the therapeutic use of FMT for several other pathologies including inflammatory bowel disease, several types of cancer, and other functional or metabolic disorders. Initial guidelines are now available to overcome some of the technical and logistical issues for establishing a non-standardized treatment into clinical practice with proper safety and governance. To aid the improvement of guidance and standardization requirements for FMT, the International Alliance for Biological Standardization (IABS) and the BIOASTER Microbiology Technology Institute hosted a joint online workshop in May of 2021. The goal of the webinar was to provide a multi-disciplinary perspective of the ongoing efforts to develop FMT guidelines including technical, regulatory, and standardization requirements. Recognized experts gave insights into state-of-the art approaches and standards developed by international organizations and institutions.

Keywords: FMT; Fecal microbiota standards; Standards.

MeSH terms

Clostridioides difficile*
Clostridium Infections* / therapy
Fecal Microbiota Transplantation
Humans
Inflammatory Bowel Diseases*
Treatment Outcome