title: [Preparation of cell therapy products: contribution of closed systems].
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.
authors.affiliation: Laboratoire de thérapeutique immuno-moléculaire, Etablissement de transfusion sanguine de Bourgogne-Franche-Comté, Besançon.
authors.forename: E
authors.initials: E
authors.lastname: Robinet
authors.forename: N
authors.initials: N
authors.lastname: Roubi
authors.forename: J M
authors.initials: JM
authors.lastname: Certoux
authors.forename: B
authors.initials: B
authors.lastname: Petracca
authors.forename: E
authors.initials: E
authors.lastname: Rousseau
authors.forename: I
authors.initials: I
authors.lastname: Newton
authors.forename: P
authors.initials: P
authors.lastname: Hervé
authors.forename: P
authors.initials: P
authors.lastname: Tiberghien
mesh_terms: D018929:Cell Culture Techniques / Q000295:instrumentation / Q000379:methods*; D002478:Cells, Cultured / Q000637:transplantation / Q000821:virology; D002498:Centrifugation / Q000379:methods; D004866:Equipment Contamination / Q000517:prevention & control; D005568:Forms and Records Control; D015316:Genetic Therapy / Q000295:instrumentation / Q000379:methods*; D005822:Genetic Vectors / Q000235:genetics*; D018380:Hematopoietic Stem Cell Transplantation / Q000295:instrumentation / Q000379:methods*; D006412:Hematopoietic Stem Cells / Q000201:enzymology / Q000821:virology; D006801:Humans; D011786:Quality Control; D012449:Safety; D018139:Simplexvirus / Q000201:enzymology / Q000235:genetics*; D013242:Sterilization; D013601:T-Lymphocytes / Q000201:enzymology / Q000821:virology; D013937:Thymidine Kinase / Q000235:genetics*; D014764:Viral Proteins / Q000235:genetics*
chemical_list: D014764:Viral Proteins; D013937:Thymidine Kinase