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Strategy to achieve biomarker-driven immunosuppression after solid organ transplantation by an academic-industry partnership within the European BIO-DrIM consortium

Hans-Dieter Volk, Bernhard Banas, Frederike Bemelman, Oriol Bestard, Sophie Brouard, Cristina Cuturi, Josep M Grinyó, Maria Hernandez-Fuentes, Martina Koch, Björn Nashan, Irene Rebollo-Mesa, Alberto Sanchez-Fueyo, Birgit Sawitzki, Ineke JM ten Berge, Ondrej Viklicky, Kathryn Wood K, Petra Reinke

Abstract

Solid organ transplantation has emerged as the “gold standard” therapy for end-stage organ failure as it improves both quality of life and survival. Despite the progress in short-term graft survival, that is closely associated with the impressive reduction of acute rejections within the first year, long-term graft and patient survival remain almost un-changed and unsatisfactory. Incomplete control of chronic allograft injury but particularly the adverse effects of long-term immunosuppression, such as graft toxicity, diabetes, cardiovascular events, infections, and tumours continue to challenge the long-term success. In general, immunosuppression is applied as one-size-fits-all strategy. This can result in over- and under-immunosuppression of patients with low and high alloresponsiveness, respectively. Trial- and -error strategies to minimize or even completely wean of immunosuppression have a high failure rate. Consequently, there is an unmet medical need to develop biomarkers allowing objective risk stratification of transplant patients. To achieve this goal, we engaged in an academic-industrial partnership. The central focus of the European-wide BIO-DrIM consortium (BIOmarker-Driven IMmmunosuppression) is the implementation of biomarker-guided strategies for personalizing immunosuppression to improve the long-term outcome and to decrease the adverse effects and costs of chronic immunosuppression in solid organ transplant patients. The concept includes four innovative investigator-driven clinical trials designed by the consortium.


Keywords

BIO-DrIM; personalized immunosuppression; biomarker; solid organ transplantation; stratification into high/low responder patients; Elispot; multiparameter flow cytometry; urinary IP-10; health-economic analyses

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DOI: http://dx.doi.org/10.18063/APM.2016.01.001
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Copyright (c) 2016 Hans-Dieter Volk, Bernhard Banas, Frederike Bemelman, Oriol Bestard, Sophie Brouard, Cristina Cuturi, Josep M Grinyó, Maria Hernandez-Fuentes, Martina Koch, Björn Nashan, Irene Rebollo-Mesa, Alberto Sanchez-Fueyo, Birgit Sawitzki, Ineke JM ten Berge, Ondrej Viklicky, Kathryn Wood K, Petra Reinke

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