Evaluating Extracorporeal Photopheresis to Treat Subclinical Antibody-Mediated Rejection After Lung Transplantation A Randomized Controlled Trial of ECP Effects on Donor-Specific Antibodies and Lung Graft Outcomes

What this Trial Is About

Researchers are evaluating the effects of extracorporeal photopheresis ECP therapy in patients who have undergone lung transplantation and have subclinical antibody-mediated rejection with persistent donor-specific antibodies dnDSAs. The study aims to determine whether ECP can reduce the mean fluorescence intensity MFI of these antibodies, and assess its impact on acute cellular rejection ACR, clinical antibody-mediated rejection AMR, chronic lung allograft dysfunction CLAD, infections, survival, adverse events, and other immunological markers. The trial will randomly assign 80 patients into two groups of 40 each. One group will receive ECP treatment starting within one week after randomization, consisting of two-day treatment cycles every two weeks for the first two months, followed by monthly two-day cycles for six months. The control group will be observed without receiving active treatment, representing the current standard of care. Researchers will compare outcomes between the groups, including immunophenotyping, miRNA profiling, cytokine expression, gene expression of peripheral blood mononuclear cells, and proteomic analysis. Participants will be monitored over six months to evaluate changes in dnDSA levels and clinical outcomes such as rejection episodes, infections, survival, and adverse effects. Assessments will include laboratory tests and immunological profiling to understand the mechanisms of ECP. This study is sponsored by the Medical University of Vienna and involves patients who are clinically stable with persistent dnDSAs and no signs of graft dysfunction after bilateral lung transplantation.

A Prospective Randomized Trial of ECP in Subclinical AMR