Mononuclear cell collection for extracorporeal photopheresis by using the “off‐line” system: A comparative study between COBE Spectra and Spectra Optia devices

Abstract

Background Extracorporeal photopheresis (ECP) is an efficient and established therapy to treat acute and chronic graft vs host disease (GVHD). Using an “off‐line” method, the first step (mononuclear cell [MNC] collection) is decisive, as long as a high MNC yield and purity in the collected product is desirable. Two “off‐line” devices were compared: the COBE Spectra and the Spectra Optia (Terumo BCT), using both continuous and intermittent protocols. Patients and methods Twelve patients with GvHD (7 acute/5 chronic) were enrolled between June 2014 and May 2015 and were alternatively assigned for each procedure to either the COBE Spectra or the Spectra Optia cell separator. Patients characteristics and procedure/product parameters were analyzed. Results Two hundred procedures (100 per device) were included. The Spectra Optia system showed higher total nucleated cells and MNC collection efficiencies (18.6(10.2‐29.7) vs 7.9(4.1‐14.8)% and 43.6(20.3‐59.5) vs 23.3(11.4‐37.1)%, P < .001) and monocyte and lymphocyte collection efficiencies (55.2(17.7‐83.2) vs 22.8(9‐38.9)% and 38.3(26.7‐53.4) vs 22.2(9‐38.9)%, respectively, P < .001). Absolute platelet loss (PL) and PL per liter of blood processed were significantly lower in the Spectra Optia group (22.9(18.3‐28.1) vs 33.6(26.5‐41.1)%, P < .001 and 3.7(3.1‐4.5) vs 4.3(3.5‐4.2)%, P = .01, respectively). However, granulocyte contamination was higher (4.5(1.3‐36) vs 1.2(0.4‐5.7)%, P < .001) and a higher product haematocrit was obtained with the Spectra Optia (1(0.5‐1.6) vs 0.3(0.2‐0.5)%, P < .001), without an impact on irradiation time. Conclusions In our study, Spectra Optia proved to be safe and effective in collecting MNC with high yield and purity for ECP in GvHD.

Inline extracorporeal photopheresis: evaluation of cell collection efficiency

“…Anyway, our primary aim was to evaluate collection efficiency according to a standard method: we observed a CE2% of 59.5%, 67.8%, and 62.3% for lymphocytes, monocytes, and MNCs, respectively. Therefore, unlike CE previously published data reporting low performance, our CE2% findings are in line with CE2% observed using common cell separators …”

“…The standard treatment of both acute and chronic GvHD is based on steroids, achieving a median complete response rate of 35% . Currently, no standard second line treatment for steroid refractory patients is available …”

Unstimulated apheresis for chimeric antigen receptor manufacturing in pediatric/adolescent acute lymphoblastic leukemia patients

“…Other centers report similar observations. [5][6][7][8][9] Median CE2 in our cohort was 53% for MNC, and 56% for T-cells. Almost identical efficiencies had been achieved by Even-Or et al in a similar patient cohort, 10 as well as in our earlier studies on extracorporeal photopheresis patient aphereses in adults when Spectra Optia had just been introduced.…”

“…It is also routinely used for preparative leukocyte collection from unmobilized patients (for extracorporeal photopheresis in patients with chronic graft-vs-host disease or chronic solid organ transplant rejection) and donors (for adoptive T-cell transfer post-transplant). [5][6][7][8][9] A lot is therefore known about best-practice apheresis planning and management. In experienced hands, apheresis is quite well tolerated even by very sick patients; it is also effective in that a technically well-performed apheresis collects approximately half the cells circulating through the connector.…”

Automated mononuclear cell collection: a feasibility study employing a new software for extracorporeal photopheresis

“…Furthermore, collection of non‐mobilized MNCs is safe both in adults and children with high quality of the product . In fact, the possibility to avoid the bias of different skills in management of MNCs harvest using manual systems may reduce the difference observed in MNCs collections outcome .…”