Fresenius Kabi USA, Lake Zurich, Illinois, USA.
Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
J Clin Apher. 2020 Aug;35(4):342-350. doi: 10.1002/jca.21804. Epub 2020 Jul 8.
A new protocol has been developed on the Amicus Separator that enables the device to perform online extracorporeal photopheresis (ECP) procedures when used in conjunction with the Phelix photoactivation device and associated disposable kit. The objective of this study was to evaluate the safety and performance of the Amicus ECP System in adult subjects with steroid-refractory or dependent chronic graft vs host disease (cGVHD).
Eight subjects with mild to severe cGVHD underwent 31 procedures. Subject safety evaluations were performed pre and post procedure and adverse events (AEs) were recorded during treatment and 24 hours after the last procedure. In vitro evaluations of the treated cells included hematology counts and lymphocyte apoptosis, viability and proliferation as measures for ECP procedure validation.
For n = 23 evaluable procedures, median (range) procedure time was 88 (78-110) minutes, during which 2.9 (0.6-4.7) × 10 TNCs (approximately 90% MNCs) were treated and reinfused to the subjects. All subject safety evaluations (vitals, cell counts, plasma hemoglobin and bacterial and endotoxin testing) were within expected ranges. All device or procedure related AEs were mild in nature. After 24 hours in culture, 86 (52-98)% of treated lymphocytes were apoptotic compared to 27 (15-51)% in controls. Inhibition of lymphocyte proliferation was >91% in all procedures.
ECP procedures were safely completed in adult subjects with SR-cGVHD treated using the new online Amicus ECP system.
新型 Amicus 细胞分离机能与 Phelix 光激活仪和相关一次性套件联合使用时，可进行在线体外光分离术（ECP）程序。本研究旨在评估 Amicus ECP 系统在对类固醇难治性或依赖性慢性移植物抗宿主病（cGVHD）的成年患者中的安全性和性能。
8 名轻度至重度 cGVHD 患者进行了 31 次程序。在治疗前和治疗后进行了患者安全性评估，并在治疗过程中和最后一次程序后 24 小时记录不良事件（AE）。对处理过的细胞进行体外评估，包括血液学计数和淋巴细胞凋亡、活力和增殖，作为 ECP 程序验证的措施。
在 n = 23 个可评估的程序中，中位数（范围）程序时间为 88（78-110）分钟，在此期间处理和回输到患者体内的 2.9（0.6-4.7）×10 TNC（约 90% MNC）。所有患者安全性评估（生命体征、细胞计数、血浆血红蛋白以及细菌和内毒素检测）均在预期范围内。所有与设备或程序相关的 AE 均为轻度。在培养 24 小时后，与对照组的 27（15-51）%相比，86（52-98）%的处理过的淋巴细胞发生凋亡。所有程序的淋巴细胞增殖抑制率均＞91%。
使用新型在线 Amicus ECP 系统治疗对类固醇难治性的成年 cGVHD 患者，成功完成了 ECP 程序。
