Red blood cell depletion in small‐volume bone marrow processing using manipulation with third‐party red blood cells: A comparison of the performance of the COBE spectra and the spectra Optia systems

Abstract

Background: For pediatric recipients, red blood cells (RBCs) are added to bone marrow (BM) collections before low RBC volume BM processing using COBE Spectra (COBE) or Spectra Optia (Optia). However, the processing efficiency of this approach has not been evaluated. This study aimed to evaluate RBC depletion and nucleated cell subpopulation recovery rates in third-party RBC-manipulated BM products processed with the COBE or Optia. Study Design and Methods: We retrospectively collected data on RBC depletion from low RBC volume BM with third-party RBCs (manipulated group) and on conventional large-volume, BM (unmanipulated group) processing performed between September 2010 and December 2021. All procedures were performed using COBE or Optia. Results: The median residual RBC volume in the manipulated group was 9.5 ml in COBE and 2.5 ml in Optia (p = .01). The median total nucleated cell (TNC) and mononuclear cell (MNC) were comparable between the manipulated groups using each cell separator (TNC, 40.8 vs. 47.1%; MNC, 78.3 vs. 79.4%). The manipulation did not adversely affect TNC and MNC recoveries in either device. In addition, Optia achieved similar CD34 + cell recovery to that in large-BM-volume processing using the same device (147.5 vs. 184.5%, p = .112). During a follow-up period, neutrophil engraftment was achieved in

Collection efficiency and safety of large‐volume leukapheresis for the manufacturing of tisagenlecleucel

“…Unlike previous reports with LVL procedures, Hb or Hct was not significantly associated with CE2 for the target cells. 22,30,35,38,39 As our study did not include healthy donors and our previous experience suggested that maintaining a high Hct at leukapheresis contributed to improved CE2 for CD34 + , 35 we attempted to proactively increase Hct before leukapheresis by RBC transfusion in daily clinical setting. As a result, approximately 70% of patients in the LVL group received RBC transfusion for leukapheresis, leading to a possibility of underestimation of the relationship between CE2 for CD3 + cells and Hb or Hct.…”

“…29,30 Following previous studies, LVL was defined as PBV ≥3-fold TBV, while normal-volume leukapheresis (NVL) was defined as PBV <3-fold TBV. [13][14][15][16][17][18][19][20][21][22]…”

“…35 This relationship was also confirmed in LVL procedures for CD34 + collection. 22 Thus, we investigated the relationships among CE2 for CD3 + cells, Hct at leukapheresis, and time to interface formation in the LVL procedures. No correlation was noted between CE2 for CD3 + cells and Hct (Figure 2D); however, a weak negative correlation was found between time to interface formation and CE2 for CD3 + cells or Hct at leukapheresis (Figure 2E,F; r = À.31, p = .14, r = À.28, p = .20, respectively).…”

“…Regarding autologous or allogeneic hematopoietic stem cell transplantation (auto-HSCT or allo-HSCT), largevolume leukapheresis (LVL) has been reported as an alternative approach to repeated leukapheresis to achieve a sufficient number of stem cells; LVL usually processes three times or more the total blood volume (TBV) of the donor, and its tolerability has been validated in various studies, including ours. [13][14][15][16][17][18][19][20][21][22] Although there have been some cases who processed blood volume exceeding threefold TBV to create CAR-T cell products in the previous reports to date, [23][24][25][26] no reports exploring the collection efficiency and safety of LVL procedures exist. Therefore, this study aimed to investigate the collection efficiency and safety of LVL for manufacturing of tisa-cel in patients with r/r B-ALL/ B-NHL.…”