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Presenter: Birgit, Sawitzki, Berlin, Germany
Authors: Birgit Sawitzki
1. What do we need to monitor during drug minimization trials?
2. Which questions should the immune monitoring help to answer?
3. Which cellular players and compartments should be studied?
4. Examples of RISET test results from selected clinical trials
Currently, many organ transplant patients receive more immunosuppression than required subsequently suffering from severe side effects such as cancer, infections and cardiovascular diseases.In contrast other transplant patients develop signs of chronic transplant damage due to insufficient immunosuppression. Thus there is an urgent need for tailor made immunosuppression according to the actual immune reactivity.
The ultimate goal of the European network RISET “Reprogramming the Immune System for the Establishment of Tolerance” was to develop safe and efficient therapies and diagnostic tools to enable drug minimization in transplant patients. We have implemented cellular assays, cell phenotyping as well as genomic and proteomic assays. A critical point was the extensive methodological validation and standardisation of assays in the performing core labs. Using this approach the RISET consortium has successfully developed new tests and defined molecular signatures of “tolerance” and rejection. Examples for assay standardisation and test results will be presented during the talk. The critical next steps are now to validate the test and assay performance in large multi center trials so that they can be introduced into regular immune diagnostics and will be accepted as surrogate markers of graft acceptance or ejection.
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