Minimum Information about T Regulatory Cells: A Step toward Reproducibility and Standardization

Anke Fuchs, Mateusz Gliwiński, Nathali Grageda, Rachel Spiering, Abul K. Abbas, Silke Appel, Rosa Bacchetta, Manuela Battaglia, David Berglund, Bruce Blazar, Jeffrey A. Bluestone, Martin Bornhäuser, Anja ten Brinke, Todd M. Brusko, Nathalie Cools, Maria Cristina Cuturi, Edward Geissler, Nick Giannoukakis, Karolina Gołab, David A. Hafler, S. Marieke van Ham, Joanna Hester, Keli Hippen, Mauro Di Ianni, Natasa Ilic, John Isaacs, Fadi Issa, Dorota Iwaszkiewicz-Grześ, Elmar Jaeckel, Irma Joosten, David Klatzmann, Hans Koenen, Cees van Kooten, Olle Korsgren, Karsten Kretschmer, Megan Levings, Natalia Maria Marek-Trzonkowska, Marc Martinez-Llordella, Djordje Miljkovic, Kingston H.G. Mills, Joana P. Miranda, Ciriaco A. Piccirillo, Amy L. Putnam, Thomas Ritter, Maria Grazia Roncarolo, Shimon Sakaguchi, Silvia Sánchez-Ramón, Birgit Sawitzki, Ljiljana Sofronic-Milosavljevic, Megan Sykes, Qizhi Tang, Marta Vives-Pi, Herman Waldmann, Piotr Witkowski, Kathryn J. Wood, Silvia Gregori, Catharien M. U. Hilkens, Giovanna Lombardi, Phillip Lord, Eva M. Martinez-Caceres, Piotr Trzonkowski

Cellular therapies with CD4+ T regulatory cells (Tregs) hold promise of efficacious treatment for the variety of autoimmune and allergic diseases as well as posttransplant complications. Nevertheless, current manufacturing of Tregs as a cellular medicinal product varies between different laboratories, which in turn hampers precise comparisons of the results between the studies performed. While the number of clinical trials testing Tregs is already substantial, it seems to be crucial to provide some standardized characteristics of Treg products in order to minimize the problem. We have previously developed reporting guidelines called minimum information about tolerogenic antigen-presenting cells, which allows the comparison between different preparations of tolerance-inducing antigen-presenting cells. Having this experience, here we describe another minimum information about Tregs (MITREG). It is important to note that MITREG does not dictate how investigators should generate or characterize Tregs, but it does require investigators to report their Treg data in a consistent and transparent manner. We hope this will, therefore, be a useful tool facilitating standardized reporting on the manufacturing of Tregs, either for research purposes or for clinical application. This way MITREG might also be an important step toward more standardized and reproducible testing of the Tregs preparations in clinical applications.