Unstimulated leukapheresis in patients and donors: comparison of two apheresis systems.

BACKGROUND: Unstimulated mononuclear cell (MNC) apheresis plays a role in the generation of donor lymphocytes (DLIs; healthy donors) and in extracorporeal photopheresis (ECP; patients). The new apheresis system Spectra Optia MNC has been shown in small studies to be capable of performing the desired cell collections, but larger data sets from real-life clinical apheresis procedures are lacking. STUDY DESIGN AND METHODS: Presented are comparative data from DLI collections randomly performed with either the new technology or a clinical standard technology, COBE Spectra MNC, as well as data from patients with chronic graft-versus-host disease undergoing MNC collections alternating between the two apheresis systems to generate products for ECP. Target cell yield and collection efficiency, product volume, nontarget cell contamination, platelet (PLT) attrition, and some process variables such as process volume and time were analyzed. RESULTS: For most relevant apheresis outcomes, differences between the devices were at best marginal. Spectra Optia MNC collections in patients, but not in donors, took 10% longer to achieve the target process volume. Not unexpectedly, given previous observations for granulocyte-colony-stimulating factor-stimulated leukapheresis, the novel device collected smaller products with less red blood cell contamination. PLT attrition with Spectra Optia MNC was markedly lower in donors. ECP apheresis outcome variability was, to a significant degree, donor dependent, irrespective of the device used. CONCLUSION: Based on more than 200 unstimulated apheresis procedures, we conclude that both apheresis systems are safe, robust, and equally suitable for unstimulated MNC collections. Both can be successfully run with manufacturer-recommended settings and algorithms.

Granulocyte collections: comparison of two apheresis systems.

BACKGROUND: Donor granulocyte concentrates are routinely administered to patients with granulocyte function defects or transient neutropenia and (risk of) bacterial or fungal exacerbations, despite lack of definitive clinical proof for patient-relevant outcome improvement. Granulocytes are collected by apheresis from healthy donors treated with granulocyte-colony-stimulating factor and/or steroids for neutrophil mobilization the evening before apheresis, as well as with hydroxyethyl starch during apheresis, to enhance sedimentation of red blood cells (RBCs) and thus to facilitate accessibility of neutrophils for collection. STUDY DESIGN AND METHODS: Granulocyte apheresis procedures are performed with standard apheresis equipment, including with the frequently used apheresis system for peripheral blood "stem cell" collection, COBE Spectra MNC (Terumo BCT), using the same tubing set as for MNC collection, but a different software protocol, PMN. An automated apheresis system for granulocyte collection, Spectra Optia IDL (Terumo BCT), became available in October 2011. Since then, 70 granulocyte apheresis procedures have been performed at our site, 35 each with the new and old systems. RESULTS: Apheresis procedures were well tolerated throughout. The target dose of 1 × 10(10) neutrophils was achieved in all but one collection with Spectra Optia IDL. Spectra Optia IDL collections were approximately 20% more efficient. Products contained more nontarget white blood cells (mononuclear cells), but fewer RBCs and platelets. Although less blood had to be processed with Spectra Optia IDL to achieve the same granulocyte dose, clinically relevant differences between the two apheresis devices were not apparent. CONCLUSION: Both apheresis systems are similarly capable of generating granulocyte concentrates.

Allogeneic donor peripheral blood "stem cell" apheresis: prospective comparison of two apheresis systems.

BACKGROUND: Granulocyte-colony-stimulating factor-mobilized peripheral blood stem cells, collected by white blood cell apheresis, are used for more than 80% of allogeneic and most autologous hematopoietic stem cell transplantations. Optimal donor and recipient outcomes require maximized stem cell collection efficiency and minimized non-target cell contamination. Therefore, improved apheresis technology is desirable. The safety and feasibility of apheresis collections with the novel, electronics-assisted apheresis system Spectra Optia v.5.0 (CaridianBCT) were recently demonstrated. An unpublished optimization trial had furthermore determined that different settings than manufacturer-installed default might result in improved apheresis yields. STUDY DESIGN AND METHODS: The first prospective comparison of allogeneic peripheral blood stem cell apheresis with the Spectra Optia versus the COBE Spectra (CaridianBCT) mononuclear cell (MNC) in a routine clinical setting is reported here; "optimized" machine settings were used. Assessed variables included collection efficiency, product characteristics, donor outcomes, and frequency of operator interventions. Outcomes were additionally compared with historical data from the Spectra Optia in default mode. RESULTS: The mean CD34+ cell collection efficiency CE1 was 7.9% greater with the Spectra Optia than with the COBE Spectra MNC. Variability of outcomes was equally great. Reduced platelet (PLT) attrition necessitated 90% fewer autologous PLT reinfusions. Spectra Optia products contained 50% fewer red blood cells, but 50% more granulocytic lineage cells. Less operator input was required, although 26% of Spectra Optia apheresis procedures required triggering of the first chamber flush. Apheresis yield and collection efficiency were also markedly greater than in default-mode Spectra Optia collections. CONCLUSION: Using optimized machine settings, peripheral blood stem cell apheresis outcomes with the automated apheresis system Spectra Optia exceed results with the COBE Spectra MNC or the Spectra Optia in the default mode.

Automatic interface-controlled apheresis collection of stem/progenitor cells: results from an autologous donor validation trial of a novel stem cell apheresis device.

BACKGROUND: Cryopreserved hematopoietic progenitor cells collected by apheresis from granulocyte-colony-stimulating factor with or without chemotherapy-mobilized patients have become the preferred type of autograft to support treatment of diseases amenable to high-dose chemotherapy. A novel apheresis system, the Spectra Optia v.5.0 (CaridianBCT), was constructed to meet certain shortcomings of manual apheresis systems such as the COBE Spectra MNC (CaridianBCT), including the need for continuous optical or manual monitoring and readjustment of buffy coat position and sensitivity to inconsistent blood flow. By use of optical sensors, which provide real-time automatic interface (buffy coat) and collection line control, the Spectra Optia promises to automatically guide apheresis procedures, potentially freeing up operator time and reducing variability in collection efficiency (CE2). STUDY DESIGN AND METHODS: In a two-center clinical trial, 35 autologous stem cell donors were subjected to apheresis with the Spectra Optia to validate feasibility and effectiveness of apheresis procedures. Results were compared to data from 80 autologous apheresis procedures with the COBE Spectra MNC. RESULTS: Usability and function of the automatic interface management were excellent. CD34+ cell quality, assessed by viability staining, colony-forming unit-culture frequency, and engraftment kinetics, was equally good with both systems. CE2 of the Spectra Optia, calculated as CD34+ contents in the product divided by the number of CD34+ cells presented to the collection port, exceeded that of the COBE Spectra MNC. Spectra Optia product volumes were significantly smaller. Very high white blood cell and platelet counts modestly reduced CE2 with the Spectra Optia. CONCLUSION: The Spectra Optia is a novel automatic apheresis system supporting autologous stem cell collection with at least equal efficiency and superior user-friendliness compared to the COBE Spectra MNC.