Abstract
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.
Highlights
T regulatory cells (Tregs) are dominant cellular compounds of the immune system protecting the body from autoimmune reactions
The design of the minimum information about Tregs (MITREG) document followed the concept of MITAP, which facilitated the whole process
Reporting guidelines will facilitate independent validation of published results, a fundamental precept of scientific research. This is to our knowledge the first proposal of a minimum information standard on the description of experimental as well as clinical manufacturing and application of Tregs
Summary
T regulatory cells (Tregs) are dominant cellular compounds of the immune system protecting the body from autoimmune reactions These cells are involved in imposing tolerance to alloantigens such as transplanted allogeneic cells and tissues [1,2,3,4,5]. At the same time, manufacturing of Tregs for preclinical and clinical experiments varies considerably between different centers, which significantly diminishes possible comparisons between the trials. For this reason, future development of these therapies is hampered as it happens that the available results from different trials are contradictive. Flow cytometry is described in MIFlowCyt, microarray data by MIAME, T-cell assays by MIATA, and production of standardized tolerogenic antigenpresenting cells by MITAP, Authors are encouraged to use these resources as appropriate
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