Standardized reporting of mononuclear cell apheresis collections: a systematic review and expert recommendations

Circulating cells to be used for cell therapy are typically collected from peripheral blood through apheresis. Objective analysis and comparison of apheresis outcomes are crucial for optimizing procedures. In this study, we reviewed published data on the performance and product characteristics of two widely used apheresis devices, Spectra Optia (Terumo Blood and Cell Technologies) and Amicus (Fresenius Kabi). We systematically searched PubMed on 18 April 2023 to retrieve studies published since 2013 reporting on mononuclear cell (MNC) collection for extracorporeal photopheresis, CD34+/stem cell collection, and CD3+/MNC/lymphocyte collection for donor lymphocyte infusion or chimeric antigen receptor T-cell manufacturing, performed using Spectra Optia and/or Amicus. We extracted data related to study design, procedure, patient population, and product. Due to heterogeneity among studies, no statistical analysis or formal comparisons were performed. We considered 82 publications: 68 on Spectra Optia, ten on Amicus, and four on both devices. We found that key parameters influencing apheresis outcomes, including patient age, weight, disease, or targeted cell content of the product, were frequently reported inconsistently or inadequately, with results often pooled across distinct populations, and limited diagnostic/indication information. Reporting of non-target cell content was also highly variable, using a wide range of units; data on red blood cells and platelets were reported more frequently than other cell types. These limitations hinder meaningful comparisons across studies. Based on these findings, an expert group developed recommendations to standardize reporting on study design, procedure, blood counts, patient characteristics, and product analysis, to support future harmonization efforts.