ChilSFree-Studie (ongoing project)
Improved results in paediatric liver transplantation have gradually shifted focus of clinical research from increasing patient survival to enhancement of long-term quality of life. One of the major challenges today is to optimise immunosuppression post transplantation in order to reduce drug toxicity and infection, whilst maintaining adequate immunosuppression to prevent rejection and graft loss. One of the difficulties in achieving this goal lies in understanding the functional level of therapeutic immunosuppression. Neither total drug exposure nor trough levels of immunosuppressive medication sufficiently reflect the pharmaceutical effects on the immune system due to a considerable inter-subject variability in the sensitivity to suppression of immune function.
ChilSFree study is a prospective, open, non-randomized observational multicentre trial and aims at characterising the changes in the immune system induced by immunosuppressive therapy after liver transplantation. We propose a prospective multicentre study in children who undergo liver transplantation. These children will receive extensive immune monitoring using a broad panel of immune markers over the course of 12 months. Development of immune monitoring data will be compared with the clinical course, notably the occurrence of infections and rejection. The ultimate scientific aim is to define markers of immune functioning that are specific to the functional degree of immunosuppression after liver transplantation, and which will eventually allow tailor-made, individualized dosing of immunosuppression for each patient.
The study implies the collaboration of different European liver transplant centres, in Germany (Hannover Medical School, principal investigator), in France, in Switzerland, in Italy, in Spain, in the United Kingdom and in Poland. This will increase the scientific gain of the study by increasing patient numbers. At the same time, structures for future collaborations will be established. A database for research purposes will be created as a new common platform for European cooperation. This will help to develop and implement common therapeutic guidelines in the field of paediatric hepatology, for the benefit of future patient care.
By February 2018, more than 200 children have been enrolled into ChilSFRee. The Helmholtz Centre for Infection Research (HZI) supports ChilSFRee in data analysis issues, and developed a new conceptual framework for the analysis of immune monitoring data.
Else-Kröner-Fresenius Stiftung (via Klin-StrucMed scholarship)