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Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials

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Sawitzki, Birgit | Harden, Paul | Reinke, Petra | Moreau, Aurélie | Hutchinson, James | Game, David | Tang, Qizhi | Guinan, Eva | Battaglia, Manuela | Burlingham, William | Roberts, Ian | Streitz, Mathias | Josien, Régis | Böger, Carsten | Scottà, Cristiano | Markmann, James | Hester, Joanna | Juerchott, Karsten | Braudeau, Cecile | James, Ben | Contreras-Ruiz, Laura | van der Net, Jeroen | Bergler, Tobias | Caldara, Rossana | Petchey, William | Edinger, Matthias | Dupas, Nathalie | Kapinsky, Michael | Mutzbauer, Ingrid | Otto, Natalie | Öllinger, Robert | Hernandez-Fuentes, Maria | Issa, Fadi | Ahrens, Norbert | Meyenberg, Christoph | Karitzky, Sandra | Kunzendorf, Ulrich | Knechtle, Stuart | Grinyó, Josep | Morris, Peter | Brent, Leslie | Bushell, Andrew | Turka, Laurence | Bluestone, Jeffrey | Lechler, Robert | Schlitt, Hans | Cuturi, Maria | Schlickeiser, Stephan | Friend, Peter | Miloud, Tewfik | Scheffold, Alexander | Secchi, Antonio | Crisalli, Kerry | Kang, Sang-Mo | Hilton, Rachel | Banas, Bernhard | Blancho, Gilles | Volk, Hans-Dieter | Lombardi, Giovanna | Wood, Kathryn | Geissler, Edward

Edité par CCSD ; Elsevier -

International audience. Use of cell-based medicinal products (CBMPs) represents a state-of-the-art approach for reducing general immunosuppression in organ transplantation. We tested multiple regulatory CBMPs in kidney transplant trials to establish the safety of regulatory CBMPs when combined with reduced immunosuppressive treatment.

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