62
Participants
Start Date
March 1, 2017
Primary Completion Date
December 31, 2022
Study Completion Date
December 31, 2022
ECP (Extracorporeal Photopheresis System)
Patients who are assigned to the ECP group receive treatments by means of the THERAKOS ® CELLEX ® Photopheresis System (Mallinckrodt Pharmaceuticals Inc.) with either double- or single-needle access. During the leukapheretic processing, 1500 ml of whole blood is processed, and peripheral blood mononuclear cells (MCNs) are separated by centrifugation and collected in the buffy coat. 8-methoxypsoralen (Uvadex®, Mallinckrodt Pharmaceuticals Inc.) at a dose of 20 μg/ml is added to the MNC collection bag and cells are irradiated with ultraviolet A light (1.5 J/cm2) in a 1-mm-thick film through a photoactivation plate. After exposure of the cells to the ultraviolet light, the buffy coat is reinfused into the patient.
Medical University Vienna, Vienna
Medical University of Vienna
OTHER