Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy.
Sezione di Ematologia, Dipartimento di Scienze Radiologiche ed Ematologiche, Università Cattolica del Sacro Cuore, Rome, Italy.
J Clin Apher. 2021 Feb;36(1):118-126. doi: 10.1002/jca.21851. Epub 2020 Oct 15.
Extracorporeal photopheresis (ECP) is an effective treatment for graft-vs-host-disease (GvHD). Photopheresis can be performed in offline or inline method. The first uses a conventional cell separator for collection of mononuclear-cells that are photoactivated by a separate device and manually reinfused; the second one involves a dedicated device performing the entire procedure (collection, photoactivation and reinfusion).
The objective was to compare the two methods and cell product features to highlight key process, devices performance, and to evaluate ECP clinical response. Patients developing steroid-resistant GvHD underwent ECP as second-line treatment using either inline (Therakos CellEx) or offline system (Terumo BCT Spectra or Optia and UVA PIT system). Data about patients' features, pre-apheresis blood-count, cell product characteristics and clinical response were collected for analysis.
We evaluated 494 procedures performed on 28 patients from April 2018 to March 2019. The offline procedure allows to achieve greater cell yield, it is characterized by larger processed blood volume, longer runtime, and higher ACD consumption. The inline procedure shows shorter runtime, high mononuclear-cells percentage and low percentage of granulocytes in cell product. We observed a significant difference in cell yields between inline and offline system; furthermore we did not find a significant relationship between cell dose and clinical response.
Inline ECP is fast, highly automated and productive, making it particularly suitable for ECP treatments. Offline ECP collects high cell yields implying longer procedure and greater operator intervention. Our study did not find a significant relationship between cell dose and GVHD response.
体外光分离术（ECP）是治疗移植物抗宿主病（GvHD）的有效方法。光分离术可离线或在线进行。前者使用传统的细胞分离机收集单核细胞，然后由单独的设备进行光激活，并手动回输；后者则使用专用设备完成整个过程（收集、光激活和回输）。
本研究旨在比较两种方法和细胞产物的特点，突出关键工艺、设备性能，并评估 ECP 的临床反应。发生激素耐药性 GvHD 的患者采用 ECP 作为二线治疗，使用在线（Therakos CellEx）或离线系统（Terumo BCT Spectra 或 Optia 和 UVA PIT 系统）。收集患者特征、预处理前血液计数、细胞产物特征和临床反应的数据进行分析。
我们评估了 2018 年 4 月至 2019 年 3 月期间 28 名患者的 494 次治疗。离线程序可获得更高的细胞产量，其特点是处理的血液量更大、运行时间更长、ACD 消耗更高。在线程序的运行时间较短，细胞产物中的单核细胞百分比高，粒细胞百分比低。我们观察到在线和离线系统之间的细胞产量存在显著差异；此外，我们没有发现细胞剂量与临床反应之间存在显著关系。
在线 ECP 快速、高度自动化且产量高，特别适合 ECP 治疗。离线 ECP 采集高细胞产量，意味着过程更长，操作人员干预更多。我们的研究没有发现细胞剂量与 GvHD 反应之间存在显著关系。
