Lung Transplant Rejection Clinical Trial
Official title:
Prophylactic Use of Extracorporeal Photopheresis (ECP) After Lung Transplantation
The purpose of this study is to investigate the use of ECP for lung-transplanted patients to reduce the occurrence of acute and chronic rejection and CMV-infection.
The intention of the planned study is the use of ECP as a form of induction treatment in combination with standard immunosuppressive therapy (IST). Two randomized cohorts (each group 31 patients), all pats with COPD, will be investigated - group A ECP with standard triple IST vs group B just with IST. Endpoints are the incidence of acute rejection episodes (about 30-40% incidence within the first year) and the development of early chronic allograft dysfunction (CLAD). Further parameters to be investigated are the number of CMV-infectious complications. Parallel to the clinical parameters and investigation of immunologic test will be performed to get a better insight into the mechanisms of ECP on the immune system. The dynamics of Tregs and dentritic cell will be analysed to compare the influence of ECP vs standard IST on these parameters. How ECP is working is still a pending question but it seems to modulate the immune response maybe via influencing Tregs and apoptosis of upregulated T lymphocytes. ;
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