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• W3024361202 abstract "Application of cell therapies in burn care started in the early 80s in specialized hospital centers world-wide. Since 2007, cell therapies have been considered as Advanced Therapy Medicinal Products (ATMP), so classified by European Directives along with associated Regulations by the European Parliament. Consequently, regulatory changes have transformed the standard linear clinical care pathway into a more complex one. It is important to ensure the safety of cellular therapies used for burn patients and to standardize as much as possible the cell sources and products developed using cell culture procedures. However, we can definitely affirm that concentrating the bulk of energy and resources on the implementation of Good Manufacturing Practice (GMP) alone will have a major negative impact on the care of severely burned patients world-wide. Developing fully accredited infrastructures and training personnel (required by the new directives), along with obtaining approval for clinical trials to go ahead, can be a lengthy process.We discuss whether or not these patients could benefit from cell therapies provided by standard in-hospital laboratories, thus avoiding having to meet rigid regulations concerning the use of industrial pharmaceutical products. Hospital Exemption could be a preferred means to offer burn patients a customized and safe product, as many adaptations may be required throughout their treatment pathway. Patients who are in need of rapid treatment will be the ones to suffer the most from regulations intended to help them.L’utilisation de la « thérapie cellulaire » au profit des patients brûlés s’est mise en place au début des années 1980 dans de nombreux centres, répartis de par le monde. Depuis 2007, les produits utilisés ont fait l’objet de directives européennes. De ce fait, la prise en charge directe du patient est devenue un parcours semé d’embûches. S’il est important d’assurer au patient l’utilisation de produits dérivés de culture cellulaire de qualité, fabriqués selon des procédés reproductibles, il est évident que la mise en place dans les unités des « Bonnes Pratiques de Fabrication » entraînera des dépenses de temps et d’énergie qui auront inévitablement un impact négatif sur la prise en charge du patient très gravement brûlé. En outre, la mise à niveau de l’infrastructure et la formation du personnel (exigées par les directives actuelles) ainsi que l’obtention des essais cliniques nécessaires à l’autorisation d’utilisation de ces produits peuvent s’avérer très longues. Nous argumentons la possibilité de fabriquer ces produits de culture cellulaire dans des laboratoires hospitaliers classiques en évitant la très lourde procédure destinée principalement à l’industrie pharmaceutique. Une « exemption hospitalière » pourrait être un moyen d’offrir aux brûlés une thérapeutique adaptée et sécurisée, dans la mesure où des adaptations personnalisées peuvent être nécessaires au long de leur traitement. Les patients ayant un besoin vital d’un traitement urgent seront ceux qui pâtiront le plus d’une loi sensée les protéger." @default.
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• W3024361202 date "2016-06-30" @default.
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• W3024361202 title "Burn patient care lost in good manufacturing practices?" @default.
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