International consensus conference on stool banking for faecal microbiota transplantation in clinical practice.

Although faecal microbiota transplantation (FMT) has a well-established role in the treatment of recurrent infection (CDI), its widespread dissemination is limited by several obstacles, including lack of dedicated centres, difficulties with donor recruitment and complexities related to regulation and safety monitoring. Given the considerable burden of CDI on global healthcare systems, FMT should be widely available to most centres.Stool banks may guarantee reliable, timely and equitable access to FMT for patients and a traceable workflow that ensures safety and quality of procedures.

European consensus conference on faecal microbiota transplantation in clinical practice.

Faecal microbiota transplantation (FMT) is an important therapeutic option for infection. Promising findings suggest that FMT may play a role also in the management of other disorders associated with the alteration of gut microbiota. Although the health community is assessing FMT with renewed interest and patients are becoming more aware, there are technical and logistical issues in establishing such a non-standardised treatment into the clinical practice with safety and proper governance.

Role of the EU Framework in Regulation of Stem Cell-Based Products.

The use of stem cells for therapeutic purposes is regulated by two overlapping sets of rules. If used for transplantation, stem cells are covered by the collection, traceability and technical aspects of three European directives. When the stem cells are used as part of a medicinal product, they are covered by the legislation on pharmaceutical production and marketing authorization-in particular, by Regulation 1394/2007/EC.