Préparation de produits de thérapie cellulaire: apport des systèmes clos |
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Authors: | E Robinet N Roubi JM Certoux B Petracca E Rousseau I Newton R Herv P Tiberghien |
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Institution: | Laboratoire de thérapeutique immuno-moléculaire, unité de thérapie cellulaire et génique Établissement de transfusion sanguine de Bourgogne-Franche-Comté, I, bd Alexandre-Fleming, 25020 Besançon cedex, France |
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Abstract: | A phase I clinical trial is being currently performed in our institution, aiming at evaluating the feasibility and toxicity related to the administration of Herpes Simplex-thymidine kinase gene-expressing human primary T lymphocytes following allogeneic hematopoietic stem cell transplantation. The need for safe and standardized preparation conditions for gene-modified cells is crucial We describe the closed culture system used in the current trial for ex vivo retroviral-mediated gene transfer and transduced cell selection. Cell handling is performed in closed systems using sampling and transfer pack bags, culture bags and a sterile connection device which avoids opening the culture system. This closed system allows safe and reproducible ex vivo preparation of gene-modified primary T-lymphocytes for clinical use. |
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Keywords: | thé rapie cellulaire thé rapie gé nique systè me clos lymphocyte TAuthor Keywords: cell therapy closed culture system gene therapy T lymphocyte |
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