BACKGROUND Extracorporeal photopheresis (ECP) is a therapeutic technique that combines leukapheresis and ultraviolet (UV)A irradiation of the leukapheresate after 8‐methoxypsoralen treatment with subsequent retransfusion. It can be achieved with a single device (online) or by combining an apheresis machine with a separate UVA light source (offline). The comparability of both established methods is unknown. STUDY DESIGN AND METHODS In a prospective setting, four ECP systems were evaluated: one with integrated UVA irradiation for online ECP (Therakos) and three with external UVA irradiation for offline ECP (Amicus, Optia, and Cobe Spectra). Apheresis variables and cell counts were determined by methods including flow cytometry. RESULTS The duration of apheresis ranged from 120 minutes (Amicus, Optia) to 275 minutes (Therakos). Mononuclear cell (MNC) counts in the treatment bags were comparable between offline ECP methods (median, 57 × 108 – 66 × 108) and lower for online ECP (14 × 108). CD16+ monocytes were abundant in online ECP (82%) but rarer in offline ECP (median, 14% – 19%). Hematocrit ranged from 0.1% (Therakos) to 8% (Amicus). There were no side effects in any patients. DISCUSSION All offline ECP systems studied yielded comparable cellular compositions and highly enriched populations of MNCs. In contrast, white blood cells from online ECP displayed enrichment of nonclassical monocytes. The relevance of these findings is unknown as there is no established biomarker to predict the therapeutic efficacy of these procedures.
These results indicate that granulocyte apheresis is feasible with MFG as well as with hetastarch and that the latter is superior for GC production, if used in the same dosage. In addition, aggregates in GC from the COBE Spectra were observed in the MFG group but not in the hetastarch group.
Background To date, in‐depth analysis of leukapheresis products as starting material for CAR T‐cell manufacturing, specifically Tisagenlecleucel production, are scarce. In this study, we report on lymphapheresis data for production of Tisagenlecleucel for elderly and pretreated lymphoma patients. Study Design and Methods Spectra Optia from Terumo BCT, Lakewood, CO, was employed for apheresis using the cMNC program. Apheresis success was defined as meeting a target total nucleated cell (TNC) count of ≥2 × 109, a CD3‐positive lymphocyte count of ≥1 × 109 and an overall viability of ≥70% in the lymphapheresis product. Results Twenty‐three patients (age 37–77 years) and 24 apheresis runs were evaluated. The median CD3‐positive lymphocyte count in peripheral blood at the beginning of apheresis was 565 cells/μl (range: 70–1345 cells/μl). Circulating lymphoma cells were detected in one patient prior to apheresis. Target criteria were met in 21 of 23 patients. The median TNC count in the apheresate was 11.2 × 109 (range: 2.9 × 109–47.4 × 109). The median CD3‐positive lymphocyte count in the apheresate was 2.55 × 109 (range: 0.370 × 109–6.915 × 109), which resulted in a median collection efficiency for CD3‐positive lymphocytes of 63.7% (range: 9.56%–93.6%). No adverse events associated with the apheresis process were observed. Conclusions Lymphapheresis with the Spectra Optia cMNC program provided a sufficient quantity of CD3‐positive lymphocytes for CAR T‐cell manufacturing for the majority of patients despite their heavy pretreatment and advanced age. Moreover, we are the first to advocate early pre‐emptive lymphocyte collection in DLBCL‐NOS patients intended to undergo treatment with Tisagenlecleucel.
Background Plateletpheresis using a leukocyte reduction system (LRS) traps donor WBCs in the LRS chamber, which may lead to lymphopenia, especially in frequent plateletpheresis donors. It seems plausible that this might cause adverse effects. However, current knowledge about potential confounders and donor health impacts is incomplete. Donors and methods Recent platelet donors and donations collected at University Hospital Regensburg from 2016 to 2019 using the Terumo BCT Trima Accel LRS system were retrospectively analyzed and compared with historical platelet donors and donations collected mainly with Fresenius Kabi Amicus non‐LRS system from 2010 to 2013. Additionally, recent donors were prospectively surveyed using a health‐related topics questionnaire. Results Analysis of 819 recent donors with 11,254 blood counts and 1464 questionnaires and 1011 historical donors with 12,848 blood counts revealed that increased annual platelet donation frequencies were associated with decreased lymphocyte counts in both groups. Median lymphocyte counts in recent donors with no versus ≥24 previous annual donations declined from 2.0 to 1.2 × 103/μL (p < 2.2 × 10−16), and those in historical donors with no versus ≥24 previous annual donations decreased from 2.0 to 1.5 × 103/μL (p = 6 × 10−4), respectively. The questionnaire results showed that donation frequency and lymphopenia were not associated with upper respiratory tract infection (URTI) incidence or duration, but platelet donors who concomitantly donated granulocytes had significantly shorter URTI durations than those who did not (p = .008). Conclusion This study confirmed that plateletpheresis‐associated lymphopenia occurs in LRS and to a lesser degree in non‐LRS platelet donors, but revealed no evidence of a negative impact on donor health.
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