仅用于病原体灭活的经紫外线C光处理的血小板浓缩物的耐受性——一项I期临床试验。

Tolerance of platelet concentrates treated with UVC-light only for pathogen reduction--a phase I clinical trial.

作者信息

Thiele T, Pohler P, Kohlmann T, Sümnig A, Aurich K, Selleng K, Westphal A, Bakchoul T, Petersmann A, Müller T H, Greinacher A, Seltsam A

机构信息

Institut für Immunologie und Transfusionsmedizin, Universitätsmedizin Greifswald, Greifswald, Germany.

DRK Blutspendedienst NSTOB, Institut Springe, Springe, Germany.

出版信息

Vox Sang. 2015 Jul;109(1):44-51. doi: 10.1111/vox.12247. Epub 2015 Mar 6.

DOI:10.1111/vox.12247

PMID:25754418

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.

摘要

背景

用于血小板浓缩物（PCs）的THERAFLEX UV-血小板病原体灭活系统仅使用紫外线C光（UVC；254纳米），无需添加光敏剂。这项I期研究评估了健康志愿者中自体UVC照射的PCs的安全性和耐受性。

方法

11名志愿者接受了两次单采（系列1和2）和一次双采（系列3）。PCs用UVC处理，储存48小时，并按剂量递增方案回输：1个PC的12.5%、25%和50%（系列1）；1个完整的PC（系列2）；2个PC（系列3）。测量血小板计数、纤维蛋白原、活化部分凝血活酶时间、凝血酶原时间、D-二聚体、标准血液学指标、体温、心率、血压和临床化学参数。在系列2和3中测定1小时和24小时校正计数增加值。在研究前和研究结束时评估血小板特异性抗体。