title: Tolerance of platelet concentrates treated with UVC-light only for pathogen reduction--a phase I clinical trial.
abstract: BACKGROUND
  The THERAFLEX UV-Platelets pathogen reduction system for platelet concentrates (PCs) operates with ultraviolet C light (UVC; 254 nm) only without addition of photosensitizers. This phase I study evaluated safety and tolerability of autologous UVC-irradiated PCs in healthy volunteers.
  
  
  METHODS
  Eleven volunteers underwent two single (series 1 and 2) and one double apheresis (series 3). PCs were treated with UVC, stored for 48 h and retransfused in a dose-escalation scheme: 12·5, 25% and 50% of a PC (series 1); one complete PC (series 2); two PCs (series 3). Platelet counts, fibrinogen, activated partial thromboplastin time, prothrombin time, D-dimer, standard haematology, temperature, heart rate, blood pressure and clinical chemistry parameters were measured. One- and 24-h corrected count increments were determined in series 2 and 3. Platelet-specific antibodies were assessed before and at the end of the study.
  
  
  RESULTS
  Neither adverse reactions related to transfusions nor antibodies against UVC-treated platelets were observed. Corrected count increments did not differ between series 2 and 3.
  
  
  CONCLUSIONS
  Repeated transfusions of autologous UVC-treated PCs were well tolerated and did not induce antibody responses in all volunteers studied. EudraCT No. 2010-023404-26.
authors.affiliation: Institut für Immunologie und Transfusionsmedizin, Universitätsmedizin Greifswald, Greifswald, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Thiele
authors.affiliation: DRK Blutspendedienst NSTOB, Institut Springe, Springe, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Pohler
authors.affiliation: Institut für Community Medicine, Universitätsmedizin Greifswald, Greifswald, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Kohlmann
authors.affiliation: Institut für Immunologie und Transfusionsmedizin, Universitätsmedizin Greifswald, Greifswald, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Sümnig
authors.affiliation: Institut für Immunologie und Transfusionsmedizin, Universitätsmedizin Greifswald, Greifswald, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Aurich
authors.affiliation: Institut für Immunologie und Transfusionsmedizin, Universitätsmedizin Greifswald, Greifswald, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Selleng
authors.affiliation: Institut für Immunologie und Transfusionsmedizin, Universitätsmedizin Greifswald, Greifswald, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Westphal
authors.affiliation: Institut für Immunologie und Transfusionsmedizin, Universitätsmedizin Greifswald, Greifswald, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Bakchoul
authors.affiliation: Institut für Klinische Chemie und Labormedizin, Universitätsmedizin Greifswald, Greifswald, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Petersmann
authors.affiliation: DRK Blutspendedienst NSTOB, Institut Springe, Springe, Germany.
authors.forename: T H
authors.initials: TH
authors.lastname: Müller
authors.affiliation: Institut für Immunologie und Transfusionsmedizin, Universitätsmedizin Greifswald, Greifswald, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Greinacher
authors.affiliation: DRK Blutspendedienst NSTOB, Institut Springe, Springe, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Seltsam
mesh_terms: D000328:Adult; D001792:Blood Platelets / Q000187:drug effects / Q000528:radiation effects*; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis; D064368:Healthy Volunteers; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D008297:Male; D010314:Partial Thromboplastin Time; D017319:Photosensitizing Agents / Q000494:pharmacology; D010976:Platelet Count; D017713:Platelet Transfusion / Q000009:adverse effects; D011517:Prothrombin Time; D014466:Ultraviolet Rays; D055815:Young Adult
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; D017319:Photosensitizing Agents; C036309:fibrin fragment D; D007073:Immunoglobulin E
keywords: UVC; pathogen reduction; phase I clinical trial; platelet concentrates