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Resume Le sujet de la table ronde etant initialement tres vaste, il avait ete convenu avec les participants de le recentrer sur les therapies cellulaires (TC) impliquant des cellules autologues utilisees dans des situations de reconstruction tissulaire, d’immunomodulation et de transduction. La TC autologue concerne aussi bien des pratiques tres innovantes que des produits utilises en routine depuis plusieurs annees. Le cadre reglementaire de la TC est maintenant finalise en France. Ce dernier met en exergue le fait qu’un produit de TC est intrinsequement lie a son procede de preparation. L’objectif de cette table ronde etait de definir les pre-requis indispensables a prendre en compte lors du developpement de therapies impliquant des preparations cellulaires ex vivo et ce, afin de s’assurer de la securite d’emploi de tels produits. Les differentes etapes du developpement d’un produit de therapie cellulaire (PTC) ont ete envisagees : (i) contraintes de production permettant de garantir la qualite du produit ; (ii) developpement non clinique : importance de modeles animaux pertinents pour demontrer la preuve du concept et affiner les specifications du PTC ; (iii) developpement clinique : specificite methodologique du developpement d’un PTC. Les problemes inherents a l’utilisation des produits therapeutiques annexes (PTA) au cours du developpement d’un PTC ont ete souleves. Des mesures ont ete envisagees pour qu’a terme l’approvisionnement et la qualite d’un PTA ne constituent pas des facteurs limitants pour le developpement de la TC en France. Enfin, une information des professionnels de sante et des industriels concernant la biovigilance s’est averee necessaire.

The topic of the round table being very broad, it was agreed with the participants that the discussion should be focused on autologous cell therapy (CT) used in tissue repair, immunomodulation or gene transduction. Autologous CT is actually comprised of both very innovative procedures as well as of products used in routine clinical practice. In France, the regulatory framework for CT has now been finalised, underlining the fact that a CT product (CTP) is intrinsically linked to the process used in its preparation. The objective of this round table was to define the essential prerequisites for the development of therapies involving ex vivo cell preparations and, more specifically, to address the issues associated with patient safety during the course of product development. The different stages of CTP development were considered: (i) requirements for CTP manufacturing in order to guarantee product quality; (ii) nonclinical development, and selection of appropriate animal models to provide the proof of the concept and support the definition of CTP specifications; and (iii) clinical development and methodological specificities of CTP development. The specific problems associated with the use of ancillary therapeutic products (ATPs) during the development of a CTP were discussed. Actions were proposed to ensure long-term supply of ATPs, which may be a significant bottleneck for the development of CT in France. Eventually, new regulatory provisions will come into force in the area of biovigilance, and it was deemed necessary for healthcare and industry professionals to be appropriately involved in the implementation phase.