Preliminary Data.
The study started on 15th September 2018 and 12 patients were enrolled in November 2019 (6 in ECP Group and 4 in Control Group). There was one drop off due to psychological difficulties. One patient in the control group died for sepsis due to pneumonia on 10th post-operation day. In the remaining 10 patients, no acute reject episodes were observed and no adverse events due to ECP were recorded. Functional and histological follow up of the grafts were performed, moreover, immune and inflammatory parameters on peripheral blood and broncholavage were evaluated. In the ECP group the immunological tests demonstrated a profound immunoregulation: 1) regulatory T cells (Treg), as well as IL10 production by Treg, were increased; 2) IL17-secreting Th17, as well as Th1 T cells, were reduced; 3) CD107+/CD8+ (perforin-releasing CTL) T lymphocytes were reduced; 4) IL10-producing NK cells were increased; 5) LPS-stimulated IL-10 production was augmented whereas that of TNFα and IL-1β was reduced. The study is still into enrolling phase, researchers estimate to finish the enrolment before September 2020.