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A good manufacturing practice method to ex vivo expand natural killer cells for clinical use |
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| Authors: | Giovanni F Torelli Carmela Rozera Laura Santodonato Nadia Peragine Giuseppina D’Agostino Enrica Montefiore Maria R Napolitano Domenica M Monque Davide Carlei Paola Mariglia Simona Pauselli Maria Gozzer Mahnaz Shafii Bafti Gabriella Girelli Anna Guarini Filippo Belardelli Robin Foà |
| Institution: | 1Haematology, Department of Cellular Biotechnologies and Haematology, Sapienza University, Rome, Italy;2Department of Haematology, Oncology and Molecular Medicine, National Institute of Health, Rome, Italy;3Transfusion Centre, Department of Molecular Medicine, Sapienza University, Rome, Italy |
| Abstract: | BackgroundGreat interest has been raised recently by the design of new adoptive immunotherapeutic strategies based on the in vivo infusion of ex vivo-expanded and activated natural killer (NK) cells. The development of good manufacturing practice (GMP) methods for the efficient production of fully functional NK cells is mandatory for clinical application.ResultsNK-cell populations expanded on average 15.7±4.7 fold by day 14, with a viability of 96% ±0.5. At the end of the incubation period, 97% ±1.1 of the expanded population was CD56+ NK cells; these effector cells showed significant up-regulation of the activating receptors NKG2D and DNAM-1. Functional tests demonstrated that expanded NK cells are fully functional with no difference whether tested before cryopreservation or after thawing.DiscussionThese data provide the basis for developing new NK-cell-based immunotherapeutic strategies for the treatment of patients with cancer. |
| Keywords: | NK cells GMP expansion and activation immunotherapy anti-cancer activity |