Comparison between intermittent and continuous spectra optia leukapheresis systems for autologous peripheral blood stem cell collection

Terumo BCT recently introduced a new system for mononuclear cell (MNC) collection that uses a Spectra Optia apheresis machine equipped with a redesigned disposable kit and software program (version 11.2). It allows for the continuous collection of MNCs, unlike the original Spectra Optia system (version 7.2), which included a chamber for two‐step cell separation. The aim of this study was to compare the two apheresis systems in regard to specific performance parameters. A retrospective data analysis of 150 patients who had undergone peripheral blood stem cell collection between March of 2014 and May of 2015 at our institution was performed. For the matched comparison, patients were divided into two groups by diagnosis and by previous forms of therapy received: a homogeneous group of patients with multiple myeloma (MM) that had received first line therapy (“MM” group, n = 88) and a heterogeneous group that included all of the other patients (“other” group, n = 62). No significant differences in CD34+ collection yields between both collection regimens were found (p_MM = 0.19, p_other = 0.74) in either group. Moreover, similar performance ratios (collected/predicted CD34+ cell number in %) were observed (p_MM = 0.89, p_other = 0.1). No relevant variations in platelet or hemoglobin loss were found between the two systems. We conclude that the new continuous Spectra Optia MNC system is equally efficient in collecting CD34+ cells and can be used without sacrificing collection efficiency levels when treating a broad variety of autologous patients. J. Clin. Apheresis 32:27–34, 2017. © 2016 Wiley Periodicals, Inc.     

Clinical impact of a new automated system employed for peripheral blood stem cell collection

At the moment, PBSC collections can be performed using semi-automated or automated cell separator devices. The automated methods offer the advantages of a decreased working load for dedicated personnel and high standardization of the collection procedure. Herein we report our single institutional experience in 80 PBSC collections employing the new automated COM.TEC Fresenius autoMNC program that provides the ability to predict the total number of CD34(+) cells collected, based on the pre-leukapheresis CD34(+) cell count in peripheral blood. Fourty-eight patients and 21 healthy donors were mobilized with chemotherapy + G-CSF or G-CSF alone, respectively. Eighty leukapheresis collections were performed starting with a CD34(+) cell count in peripheral blood at least of 20/microL. Collection parameters and related side effects were evaluated. The mean CD34(+) cell collection efficiency in patients and donors was 81.8% (sd 27.6) and 95.1% (sd 15.6), respectively. The mean difference between real and predicted CD34(+) cells was +30.2% (sd 92.9) for patients and +4.6% (sd 30.3) for donors. The mean leukapheresis bag volume was 240.7 ml (sd 67.3) and 310.3 ml (sd 86.8) with a mean HCT of 10.9% (sd 34.4) and 9.2% (sd 3.9) for patients and donors, respectively. The automated PBSC collection with the new program COM.TEC Fresenius autoMNC demonstrated a very high CD34(+) cell collection efficiency. Moreover, the ability to predict the CD34(+) cell yield permits improved management of the leukapheresis collection, with the only disadvantage of larger leukapheresis volume and higher hematocrit.     

Manual color monitoring to optimize hematopoietic progenitor cell collection on the Fenwal Amicus

A technique was developed to improve consistency of MNC transfers from the centrifuge to the collection bag in the Fenwal Amicus. The operator assures that RBCs completely fill the cassette by the end of the transfer by adjusting the RBC offset in succeeding cycles. We compared yields and crosscellular content before and after implementation of the monitoring technique. Retrospective data from 400 consecutive HPC collection procedures (200 for each technique) were compared. In 40 monitored collections, the RBC offset was adjusted to 6-9 mL to ensure that RBCs completely filled the cassette. Collections requiring these adjustments were not associated with a specific diagnosis. Median values were compared between the 40 collections requiring offset adjustment and those performed before implementation of monitoring. Baseline peripheral CD34+ cell (17 vs. 14 cells μL(-1)), lymphocytes (2 vs. 1.3 × 10(9) /L), WBCs, HCT, and PLTs were significantly higher in the group requiring offset changes. The group requiring offset changes had significantly more CD34+ cells per collection (190.8 × 10(6) or 2.04 × 10(6) /kg vs. 84.3 × 10(6) or 0.89 × 10(6) /kg) and more lymphocytes per collection (16.9 × 10(9) vs. 11.6 × 10(9)). Crosscellular content of the group requiring offset changes was significantly higher for WBCs (41.8 vs. 33.1 × 10(9)), granulocytes (9.6 vs. 7.2 × 10(9)), RBCs (23 vs. 17 mL), and PLTs (2.1 vs. 1.2 × 10(11)). Manual monitoring is a simple, inexpensive method to optimize each HPC collection to maximize CD34+ cell and lymphocyte yields.     

Comparison of CD34+ cell collection efficiency on the COBE Spectra and Fenwal CS-3000 Plus

Optimal collections of mobilized CD34+ cells are important in terms of both patient toxicity and cost. The factors that determine CD34+ collection efficiency (CD34eff) of cell separators have not been well studied. In addition, because several cell separators are available, the type of collection device may also be a significant variable. Previous studies comparing the Baxter-Fenwal CS3000 and the COBE Spectra have not yielded consistent conclusions. Therefore, we retrospectively analyzed the collection outcomes of 163 consecutive donors with a peripheral CD34+ cell concentration (pCD34) of > or =5 cells/microl on the first collection that had been harvested on one or the other device. The CS3000 was found to yield a significantly higher CD34eff (50% vs. 39%, P = 0.006). However, donors were not balanced for several prognostic factors, which may contribute to CD34eff including mobilization with G-CSF vs. chemotherapy+G-CSF, average flow rate, and total volume of peripheral blood processed. When appropriate variables were included in a stepwise multiple variable analysis, cell separator type emerged as a significant independent predictive factor for CD34eff (P = 0.018). Our data indicates that the CS3000 will, on average, show a higher absolute CDeff of 8%. Furthermore, since the two devices differ in mechanism, prognostic factors may also differ. Comparisons suggest that peripheral blood WBC and hematocrit may be more important predictors for the CS3000.     

Evaluation of a new protocol for peripheral blood stem cell collection with the Fresenius AS 104 cell separator

In this report we analyzed sixty leukapheresis procedures on 35 patients with a new protocol for the Fresenius AS 104. Yields and efficiencies for MNC, CD 34+ cells, and CFU-GM indicate that the new protocol is able to collect large quantities of hemopoietic progenitors. Procedures were performed processing 8.69 ± 2.8 liters of whole blood per apheresis and modifying 3 parameters: spillover-volume 7 ml, buffy-coat volume 11.5 ml, centrifuge speed 1,500 rpm; blood flow rate was 50 ml/min and the anticoagulant ratio was 1:12. No side effects were observed during apheresis procedures except for transient paresthesia episodes promptly resolved with the administration of calcium gluconate. Yields show a high capacity of the new program to collect on average MNC 17.28 ± 10.85 × 10⁹, CD 34+ 471 ± 553.5 × 10⁶ and CFU-GM 1278.7 ± 1346.3 × 10⁴ per procedure. Separator collection efficiency on average was 49.91 ± 23.28% for MNC, 55.1 ± 35.66% for CFU-GM, and 62.97 ± 23.09% for CD 34+ cells. Particularly interesting are results for MNC yields and CD 34+ efficiency; these results make the new program advantageous or similar to the most progressive blood cell separators and capable to collect a sufficient number of progenitor cells for a graft with a mean of 1.80 ± 0.98 procedures per patient. J. Clin. Apheresis 12:82–86, 1997. © 1997 Wiley-Liss, Inc.     

Reflections on methodical approaches to hematopoietic stem cell collection in children

Pediatric peripheral blood stem cell collection (PBSC) is challenging because it has potentially more side effects than in adults due to the small body mass and unique physiology of children. The extracorporeal volume of the cell separator device, poor venous access and metabolic complications due to citrate toxicity are the main problems to face during PBSC collection. These aspects are more relevant in very low body weight (BW) children of 20?kg or lower. An efficient, experienced and well-prepared team of pediatricians, apheresis physicians and nurses, and physicians involved in CVC positioning is crucial to performing a safe PBSC collection. Despite the growing demand for PBSC collection in the pediatric setting, there is not an actual unique standardized detailed practice approach to be employed, therefore, on reflection, we believe that it is timely to draw up useful evidence-based recommendations on which guidelines can be developed for use by those groups with limited or no experience.     

Autologous peripheral blood stem cell collections in children weighing less than 10 Kg with solid tumors: experience of a single center

There have only been a few reports and limited performance of peripheral blood stem cell (PBSC) collection in very small children weighing less than 10 kg. In this study, we intended to evaluate the safety and yield of PBSC collection, with the efficacy of PBSC transplantation (PBSCT) in the smallest children with solid tumors. From January 1998 to February 2004, 173 children underwent PBSC collection in Samsung Medical Center, Korea. Of these, 15 (8.7%) children weighed less than 10 kg and their clinical diagnoses were neuroblastoma (10 cases), rhabdoid tumor (2 cases), rhabdomyosarcoma (2 cases), and Wilms tumor (1 case). PBSCs were collected following chemotherapy plus G-CSF mobilization. The median age and weight at the time of apheresis were 15 months and 9 kg, respectively. The median number of PBSC collection procedures per case was 4 (range, 2-7). The median cell yield per apheresis product was 0.95 (range, 0.01-33.32) x 10(6)/kg CD34+ cells and 1.96 (range, 0.12-23.39) x 10(8)/kg mononuclear cells. No complications associated with citrate toxicity and other adverse effect were observed during the procedures. After high-dose chemotherapy, 14 patients were reinfused with PBSCs alone and all showed successful hematopoietic recovery. We concluded that PBSC collection would be a safe and practical procedure, even when done in the smallest children, provided that adequate intravascular fluid volume and circulating red cell mass were maintained. Also, the use of PBSCs to support high-dose chemotherapy was well tolerated and might enhance hematological recovery in the smallest children showing the excellent efficacy of PBSCT.     

Adjustment of the interface detector (location 71) to the absolute number of mononuclear cells in the peripheral blood: No improvement of the collection efficiency of the Fenwal CS3000 plus during progenitor cell harvests

Improvement of the collection efficiency (CE) of the Fenwal CS3000 plus in collecting circulating progenitor cells (CPC) might diminish the number of leukapheresis procedures (LP) required to obtain the CPC required to assure engraftment. We analyzed whether adjustment of the optical setting (location 71,L71) to the number of MNC present in the peripheral blood could enhance the CE of the MNC. Thirty-five patients underwent 121 LP with an adjusted L71. We compared the results retrospectively with 26 LP performed with a fixed L71 (1:100) in 12 patients. The CPC were mobilized with chemotherapy followed by subcutaneous administration of granulocyte colony-stimulating factor (G-CSF) in both groups. Adjustment of the L71 did neither improve the CE of the MNC, the estimated CE of CD34+ cells nor diminished granulocyte contamination. For the total 121 LP with an adjusted L71 and for the total 26 LP with a fixed L71 the mean CE of MNC were, respectively, 44.6 ± 18.3% and 46.4 ± 14%. The mean granulocyte contamination, determined by manual white blood cell differentiation, was 1.7 ± 2.3% for the adjusted L71 group and 2.3 ± 3 for the fixed L71 group. There was no difference in the median number of LP required to obtain 3 × 10⁶ CD34+ cells/kg between both groups. We found a weak significant correlation between WBC and pre-LP MNC count and the CE of MNC (r = 0.36, P = 0.012, resp.r = 0.33, P = 0.023), but no correlation between the CE of MNC and the estimated CE of CD34+ cells (r = 0.24, P = 0.113). In conclusion, adjustment of the L71 to the MNC did not improve the CE of MNC of the Fenwal CS3000. The lack of correlation between the CE and MNC and the estimated CE of CD34+ cells should be further explored. J. Clin. Apheresis 12:68–73, 1997. © 1997 Wiley-Liss, Inc.     

Determining factors predictive of CD34+ cell collection efficiency in an effort to avoid extended and repeated apheresis sessions

Introduction: Collection efficiency (CE) is a reflection of the proportion of cells passing through a cell separator that is harvested. The aim of our study was to evaluate which factors influence CE independently in order to find ways to improve CE and therefore minimize the costs and risks of leukapheresis and graft processing. Materials and Methods: A total of 206 consecutive apheresis procedures performed on 128 donors/patients were studied retrospectively. We explored the association between CE and the following factors: age, sex, weight, mobilization (granulocyte‐colony‐stimulating factor with or without chemotherapy), collection type (autologous versus allogeneic), venous access (peripheral versus central), total processed blood volume (TPV), hematocrit, white blood cell (WBC) count, thrombocyte count, and peripheral blood CD34+ cell concentration (PBCD34+). Results: Stepwise multiple regression analysis showed WBC count to be the single best predictor of CE, accompanied by TPV. When performing subgroup analysis for autologous apheresis procedures, the inverse correlation of WBC count and TPV with CE becomes stronger (r = ?0.563 with P < 0.001 and r = ?0.198 with P = 0.020 respectively), whereas those correlations disappear when analyzing only allogeneic apheresis procedures. Conclusion: The negative correlation between TPV and CE present only in autologous collection procedures can be explained by the limited intra‐apheresis recruitment of CD34+ cells into the blood which is negatively influenced by extensive pre‐treatment. As a result of this study we decided to limit TPV to a maximum of three times the patient's blood volume in autologous apheresis procedures at our center. J. Clin. Apheresis, 28:404–410, 2013. © 2013 Wiley Periodicals, Inc.     

Comparison of two leukapheresis programs for computerized collection of blood progenitor cells on a new cell separator

BACKGROUND: Peripheral blood progenitor cells (PBPCs) can be collected on various cell separators. Two leukapheresis programs (LP-MNC and LP-PBSC-Lym) were evaluated for computerized collection of PBPCs on a new cell separator. STUDY DESIGN AND METHODS: Leukapheresis assisted by the LP-MNC or LP-PBSC-Lym software was performed for the harvesting of PBPCs in 52 oncology patients after chemotherapy plus G-CSF treatment and in 18 healthy subjects after G-CSF mobilization alone. RESULTS: A total of 38 components from 33 donors via LP-MNC and 43 components from 37 donors via LP-PBSC-Lym were collected with a median of one (range, one to two) standard-volume leukapheresis procedures (9.2-13.3 L) per donor. There were no significant differences between the two groups concerning median counts of WBCs, CD34+ cells, CD34+ cell yields per harvest, and CD34+ cell yields of cumulative harvests. The blood cell counts after leukapheresis revealed that the LP-MNC resulted in significantly higher platelet loss than LP-PBSC-Lym (p = 0.024): 35.9 percent (range, 19.2%-66.1%) versus 29.7 percent (11.6%-52.3%). Regarding the CD34+ cell collection efficiency, the LP-MNC program was significantly better than the LP-PBSC-Lym program (p < 0.001): 77.5 percent (range, 35.5%-98.9%) versus 58.3 percent (range, 20.4%-98.9%). However, concentrates collected by the LP-PBSC-Lym program had significantly higher percentages of MNCs (p < 0.001) and CD34+ cells (p = 0.028) than harvests with the LP-MNC program: 90 percent (range, 69%-99%) versus 70 percent (range, 35%-98%) and 1.2 percent (range, 0.2%-7.3%) versus 0.7 percent (range, 0.2%-6.0%), respectively. No leukapheresis-related serious adverse events were seen, and time for hematopoietic engraftment was equivalent to data published in the literature. CONCLUSION: The LP-MNC program shows a significantly better CD34+ cell collection efficiency than the LP-PBSC-Lym program. However, collections with the LP-MNC program result in PBPC components with a lower MNC and CD34+ cell concentrations and a higher apheresis-related loss of patient's platelets.