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Transfusion and Apheresis Science xxx (2007) xxx–xxx

intl.elsevierhealth.com/journals/tras

Comparison of the Fenwal Amicus and Fresenius Com.Teccell separators for autologous peripheral blood progenitor

cell collection

Fevzi Altuntas a,*, Ismail Kocyigit a, Ahmet Ozturk b, Leylagul Kaynar a,Ismail Sarı c, Mehmet Oztekin a, Musa Solmaz a, Bulent Eser a,

Mustafa Cetin a, Ali Unal a

a Erciyes Medical School, Department of Hematology and Apheresis Unit, Kayseri 38039, Turkeyb Erciyes Medical School, Department of Biostatistics, Kayseri, Turkey

c Pamukkale Medical School, Department of Hematology and Apheresis Unit, Denizli, Turkey

Received 1 September 2006; received in revised form 4 October 2006; accepted 10 October 2006

Abstract

Peripheral blood progenitor cells (PBPC) are commonly used as a stem cell source for autologous transplantation. Thisstudy was undertaken to evaluate blood cell separators with respect to separation results and content of the harvest. Fortyautologous PBPC collections in patients with hematological malignancies were performed with either the Amicus or theCOM.TEC cell separators. The median product volume was lower with the Amicus compared to the COM.TEC(125 mL vs. 300 mL; p < 0.001). There was no statistically significant difference in the median number of CD34+ cell/kg in product between the Amicus and the COM.TEC (3.0 · 106 vs. 4.1 · 106; p = 0.129). There was a statistically highermean volume of ACD used in collections on the Amicus compared to the COM.TEC (1040 ± 241 mL vs. 868 ± 176 mL;p = 0.019). There was a statistical difference in platelet (PLT) contamination of the products between the Amicus and theCOM.TEC (0.3 · 1011 vs. 1.1 · 1011; p < 0.001). The median % decrease in PB PLT count was statistically higher in theCOM.TEC compared to the Amicus instruments (18.5% vs. 9.5%; p = 0.028). In conclusion, both instruments collectedPBPCs efficiently. However, Amicus has the advantage of lower PLT contamination in the product, and less decreasein PB platelet count with lower product volume in autologous setting.� 2007 Elsevier Ltd. All rights reserved.

Keywords: Cell separators; Peripheral blood progenitor cells; Autologous; Apheresis

1473-0502/$ - see front matter � 2007 Elsevier Ltd. All rights reserved

doi:10.1016/j.transci.2006.10.008

* Corresponding author. Tel.: +90 352 437 49 37; fax: +90 352437 93 48.

E-mail address: faltuntas@hotmail.com (F. Altuntas).

Please cite this article in press as: Altuntas F et al., CompaTransf Apheres Sci (2007), doi:10.1016/j.transci.2006.10.008

1. Introduction

Peripheral blood progenitor cells (PBPC) havebeen used successfully and reliably to restore mar-row function in cancer patients, whose hematopoie-sis has been ablated by chemo-radiotherapy [1–6].

.

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PBPCs collected by apheresis after mobilizationwith chemotherapy and/or granulocyte-colony stim-ulating factor (G-CSF) have mostly replaced bonemarrow (BM) as a stem cell source for hematopoi-etic cell support [1–8]. The literature indicates thatthere is a lower incidence of documented infections,decreased transfusion requirements, lower demandfor antibiotics and, possibly, reduced patient carecosts compared with BM grafts [2,8–14]. Addition-ally, the clinical use of PBPCs may offer such advan-tages over bone marrow as the avoidance surgeryand the possibility of collection on an outpatientbasis [1–3,15].

A variety of apheresis devices are now availableon the market to collect PBPCs [1,2,16–27]. Thenew Fenwal Amicus cell separator (Baxter Health-care, Deerfield, IL, USA) and the COM.TEC cellseparator’s (Fresenius HemoCare GmbH, BadHomburg, Germany) mononuclear cell (MNC) col-lection program are currently available for clinicaluse [19–21,23]. A more efficient collection of PBPCswith fewer apheresis related risks is important forautologous patients. However, there are scant dataregarding separation statistics and content of theharvest with the COM.TEC machine [23]. Addition-ally, there is no published study comparing theAmicus and the Fresenius COM.TEC cell separa-tors used for autologous PBPCs leukapheresis.Therefore, in this study, our aim was to evaluateand compare blood cell separators with respect toseparation results and content of the harvest.

2. Materials and methods

2.1. Patients

We evaluated the data of autologous PBPC col-lection with the Amicus and the COM.TEC cell sep-arator between June 2005 and August 2006.Inclusion criteria for the study were as follows:relapsed/refractor Hodgkin’s disease (HD) andnon-Hodgkin’s lymphoma (NHL), new diagnosismultiple myeloma (MM), 665 years of age, nonpregnant, Eastern Cooperative Oncology Group(ECOG) performance score 62, normal cardiacfunction (systolic ejection fraction >50%), serumcreatinine level <2.0 mg/dL, no active bacterial orfungal infections at the time of study and negativeanti-human immunodeficiency virus (HIV) 1/2.Thirty-two patients (26 males, 6 females) underwentautologous PBPCs leukapheresis. Of these, 16 had adiagnosis of NHL, 10 HD and 6 MM. The median

Please cite this article in press as: Altuntas F et al., CompaTransf Apheres Sci (2007), doi:10.1016/j.transci.2006.10.008

age was 31 years (range: 16–65 years), the medianactual body weight (BW) was 70 kg (range: 47–85 kg) and median total blood volume (TBV)4900 mL (range: 3290–5950 mL).

2.2. Mobilization and collection of PBPCs

All patients received high-dose cyclophospha-mide (4 g/m2) and filgrastim (G-CSF) to mobilizePBPCs (Amgen-Roche) (10 lg/kg/day, beginningon day 3 until completion of the PBPCs collection).PBPCs were harvested when the peripheral blood(PB) leukocyte count was P1 · 109/L and CD34+cells in the PB were P10/lL. Patients underwentleukapheresis using a 16 G backeye access needlein an antecubital fossa vein; a 20 G venous cannulawas placed in the opposite arm for the return line.Central venous catheters (12 F, Arrow) were usedin patients with an inadequate peripheral venousaccess. Patients were randomly assigned to undergoPBPC collection with the Baxter Amicus cell sepa-rator and the Fresenius COM.TEC device. The tar-get dose of CD34+/kg BW was P3 · 106. In orderto avoid severe hypocalcaemia during the proce-dure, all patients received an intravenous infusionof 10% calcium gluconate (30 mL), providing upto 819 mg of calcium. Senior apheresis techniciansperformed all procedures. Vital signs were moni-tored at the beginning and end of each procedure,and patients were monitored for adverse eventsduring the apheresis procedures. Written informedconsent was obtained from all patients after proce-dural risks were explained in detail before eachprocedure

2.3. Blood cell separators

2.3.1. Amicus instrument

The PBPC collection by the Amicus cell separa-tor is controlled via the MNC collection computersoftware (version 2.52). The Amicus device uses asingle chamber design to collect PBPCs; however,the collection process occurs in stages. Anticoagu-lated whole blood enters through the inlet lineand is separated immediately into red blood cells(RBC) and plasma. The plasma carries platelets(PLT) out of the chamber for return to the patient.Some plasma is re-circulated in the centrifugeduring the separation stage; an auto-elutriationprocess enhances separation of PLTs from MNCsand reduces PLT content in the PBPC product.Polymorph nuclear cells exit the chamber with

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the high-hematocrit RBCs while the MNCs remainin the chamber during each cycle. During the har-vest stage of each cycle, the hematocrit of thechamber is increased to isolate the MNC layer;then, the position of the chamber interface is raiseduntil the MNCs begin to exit through the plasmaline. Thus, the collection of the PBPC is an inter-mittent process. The MNCs collected by the deviceare diverted into a plastic storage bag (R4R9955,Baxter) which is integrally attached to the collec-tion harness and located outside the centrifuge.The Amicus device parameters were set as follows:A flow rate of 40–65 mL/min, MNC set point at0.6, RBC collection value at 6.2–7.5, cycle volumeat 1000–1400 mL, number of cycles varied from 7to 14, anticoagulant/whole blood ratio = 1:12–15.A total of 100–150 mL of plasma was collectedto rinse the PBPC collection line after theprocedure.

2.3.2. Com.Tec instrument

The PBPC collection by the COM.TEC cell sep-arator is controlled via the MNC collectioncomputer software (version 4.0). Dual-needle leuk-apheresis kits were used according to the manufac-turer’s instructions. The COM.TEC machine runswith a continuous blood flow. At the start of theapheresis procedure, the donor’s sex, body weight,height, hematocrit level and white blood cell(WBC) counts are entered into the machine. Thesoftware calculations are based on the individualWBC count of the donor, the exact PB volumethat must be processed before every buffy coat(BC) collection cycle and, finally, the volumes ofthe spillover (SO) phase and the BC phase. Thus,the MNCs are cyclically collected at the end ofeach individually determined separation cycle.Nonetheless, the operator can adjust the volumeof the separation cycle, the SO, and BC volumesduring the apheresis procedure when appropriate.The MNC program works with a one-stage cham-ber (P1Y leukapheresis kit, Fresenius HemoCare).One separation cycle consists of separation, SOand BC phases. In the separation phase, anticoag-ulated PB enters the separation chamber and isseparated into RBCs, BC, and PLT-rich plasma.During the separation cycle, the RBCs are contin-uously returned to the donor via the RBC port;the PLT-rich plasma is returned to the donor viathe plasma port. While RBCs and PLT-richplasma are running back to the donor, the WBCsaccumulate as a BC in the separation chamber.

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The BC position is controlled by an optical inter-face monitor. When the preset separation cyclevolume has been reached, the blood flow isreduced to concentrate the BC. In spillover phase,the plasma pump draws the BC to the plasma portof the separation chamber by pumping a presetplasma volume. In the buffy coat phase, theplasma pump is stopped and the BC is pumpedby the cell pump into the collection bag. TheFresenius COM.TEC instrument parameters wereset as follows: whole blood flow rate set at 40–60 mL/min, cycle volume at 300–500 mL, the num-ber of cycles varied from 25 to 40, anticoagulant/whole blood ratio = 1:10–14.

2.4. Laboratory analysis

2.4.1. Pre- and post-apheresis peripheral blood

variables

Peripheral blood samples (2 mL, ethylene dia-mine tetra acetate [EDTA]) were drawn from eachpatient (inlet line) prior to and two hours after com-pletion of apheresis. Pre-apheresis complete bloodcount (CBC) and CD34+ cell analysis were per-formed. Post-apheresis CBC was repeated.

2.4.2. Leukapheresis operational variables

For all procedures the separation time, processedblood volume, flow rate and acid citrate dextrose-A(ACD) volume used was recorded.

2.4.3. Leukapheresis product variables

Leukapheresis product samples with EDTA(2 mL) were obtained for laboratory analysis. Har-vest product was analyzed for volume, the numbersof collected total nucleated cells (TNC), MNCs andCD34+ cells. RBC and PLT contamination were alsoevaluated. In addition, the collection efficiencies (CE)of CD34+ cells were calculated based on patient’sblood volume: CE (%) = total cells obtained fromthe apheresis · 100/(peripheral cells/mL · apheresisvolume processed mL).

Blood cell counts of the PB and the leukaphere-sis product were determined using an automatedblood cell counter (Sysmex XT 2000i, Roche diag-nostics, Sysmex Corporation, Kobe, Japan).CD34+ cells were determined by flow cytometryon a FACSCalibur (Becton Dickinson, CA, USA)in the PB and leukapheresis products followingthe recommendations of the International Societyof Hematotherapy and Graft Engineering (ISH-AGE) [28].

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Table 1Patient’s characteristics

Amicus COM.TEC

Number of patients 15 17Diagnosis (NHL/HD/MM) (n) 7/4/4 9/6/2Male/female (n) 11/4 15/2Age (years), median (range) 32 (16–65) 40 (18–64)Weight (kg), mean ± SD 64.3 ± 14.2 70.6 ± 11.3TBV (mL), mean ± SD 4594 ± 831 4983 ± 746

HD, Hodgkin’s disease; NHL, non-Hodgkin’s lymphoma; MM,multiple myeloma; TBV, total blood volume.

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2.4.4. Statistical analysis

Data were expressed as the median (range) andmeans ± standard deviation (SD). Data wereanalyzed with an SPSS program (SPSS 13.0, Inc.,Chicago, IL). We compared the Amicus and theCOM.TEC machines by using an unpaired t-testor the Mann–Whitney U-test in terms of pre- andpost-apheresis peripheral blood variables, leukaphe-resis operational variables and leukapheresis prod-uct variables (harvest content). An unpaired t-testwas used for peripheral blood variables which werewithin normal distribution, e.g., pre-apheresis WBCcount, pre-apheresis CD34+ cell count, pre-aphere-sis hemoglobin (Hb) level, post-apheresis Hb leveland % decrease of Hb level, leukapheresis opera-tional variables (e.g., blood volume processed,ACD-A volume and separation time) and leukaphe-resis product variables (e.g., the CE of CD34+ celland PLT count/lL). The Mann–Whitney U-testwas applied for peripheral blood variables whichwere not within normal distribution (e.g.,pre-apheresis PLT count, post-apheresis PLT countand % decrease of PLT count), leukapheresis oper-ational variables (e.g., flow rate, product volume)and leukapheresis product variables (e.g., TNCcount/lL, MNC count/lL, MNC count/bag,MNC count/kg BW, CD34+ cell/lL, CD34+ cell/bag, CD34+ cell/kg BW, RBC count/lL, RBCcount/bag and PLT count/bag). Statistical signifi-cance was set at p < 0.05.

3. Results

Forty autologous PBPCs collections with theAmicus (patients = 15, procedure = 20) and theCOM.TEC (patients = 17, procedure = 20) wereperformed within study period. Patient characteris-tics, i.e., diagnosis, sex, age, weight and TBV on

Table 2Peripheral blood data pre-and post-leukapheresis

Am

Pre-apheresis WBC (·103/lL), mean ± SD 11 ±Pre-apheresis CD34+ cell (·103/lL), mean ± SD 42.6Pre-apheresis Hb level (g/dL), mean ± SD 10.0Post-apheresis Hb level (g/dL), mean ± SD 8.8% Decrease of Hb level, mean ± SD 11.8Pre-apheresis PLT count (·103/lL), median (range) 75 (Post-apheresis PLT count (·103/lL), median (range) 59 (% Decrease of PLT count, median (range) 9.5

WBC, white blood cell; Hb, hemoglobin; PLT, platelet; SD, standard

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the Amicus and the COM.TEC are shown inTable 1.

3.1. Pre- and post-apheresis peripheral blood

variables

Pre- and post-apheresis PB data are shown inTable 2. There were no significant differences interms of pre-apheresis PB Hb levels, PLT countand WBC count between the Amicus and theCOM.TEC device (Table 2). However, pre-apheresisPB CD34+ cells was higher in patients on theCOM.TEC compared to on the Amicus device(58.5 ± 20/lL vs. 42.6 ± 14.4/lL) (p = 0.010). Therewas no statistical difference in terms of post-aphere-sis PB PLT count between two devices (p = 0.597).Additionally, post-apheresis PB Hb level was lowerin the Amicus compared to the COM.TEC instru-ment (8.8 ± 1.4 g/dL vs. 9.5 ± 1.5 g/dL); however,it was not significant (p = 0.137). There was a highermedian % decrease in PB platelet count in collectionson the COM.TEC compared to the Amicus (18.5%vs. 9.5%) (p = 0.028). Further, the mean % decreasein PB Hb level was statistically higher with the Ami-cus compared to the COM.TEC instrument (11.8 ± 4.1% vs. 5.5 ± 3.0%; p < 0.001).

icus COM.TEC p

7.9 8.1 ± 6.7 0.239± 14.4 58.5 ± 20.0 0.010± 1.5 9.9 ± 1.6 0.902

± 1.4 9.5 ± 1.5 0.137± 4.1 5.5 ± 3.0 <0.001

28–178) 66 (25–194) 0.68123–168) 57 (20–156) 0.597(2.4–41.8) 18.5 (4.0–42.0) 0.028

deviation.

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3.2. Leukapheresis operational variables

The mean blood volume processed was signifi-cantly higher with the Amicus (13,422 ± 2156 mL)compared to the COM.TEC device (10,092 ±1688 mL) (p < 0.001). There was a significantlyhigher mean volume of ACD used in collectionson the Amicus compared to the COM.TEC bloodcell separator (1040 ± 241 mL vs. 868 ± 176 mL;p = 0.019). The mean separation time was alsosignificantly longer in the Amicus than in theCOM.TEC device (290 ± 30 min vs. 226 ± 41 min;p < 0.001). Additionally, there was a statisticallysignificant difference between the median volumeof products for the Amicus and the COM.TECdevice (125 mL vs. 300 mL; p < 0.001). Leukaphere-sis collection data are shown Table 3.

3.3. Leukapheresis product variables

Leukapheresis product data by instrument issummarized in Table 4. The median TNC yieldwas higher on the Amicus compared to theCOM.TEC device (165 · 103/lL vs. 79 · 103/lL;

Table 3Leukapheresis collection data

Amicus

Number of procedures 20Blood volume processed (mL), mean ± SD 13,422 ± 2Flow rate (mL/min), median (range) 55 (39–65)ACD-A volume (mL), mean ± SD 1040 ± 241Separation time (min), mean ± SD 290 ± 30Product volume (mL), median (range) 125 (80–18

ACD, acid citrate dextrose; SD, standard deviation.

Table 4Leukapheresis product data

Amicus

TNC (·103/lL), median (range) 165 (93–30MNC (·103/lL), median (range) 115 (70–18MNC, total/bag (·108), median (range) 129 (61–22MNC (·108/kg), median (range) 2.1 (1.3–4.CD34+ cell (/lL), median (range) 2126 (1172CD34+ cell, total/bag (·108), median (range) 24.2 (10–5CD34+ cell (·106/kg), median (range) 3.0 (1.6–7.CE of CD34+ cell, mean ± SD 51.0 ± 17.4RBC (106/lL), median (range) 1.3 (0.3–3.RBC, total/bag (106), median (range) 1.6 (0.4–2.PLT (103/lL), mean ± SD 393 ± 299PLT, total/bag (·1011), median (range) 0.3 (0.1–1.

TNC, total nucleated cells; MNC, mononuclear cells; CE, collection effi

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p = 0.008). Further, the median total MNC yieldwas higher with Amicus in comparison to COM.-TEC (115 · 103/lL vs. 57 · 103/lL; p = 0.006).However, the median MNC count per componentwas significantly higher with the COM.TEC com-pared the Amicus device (176 · 108/bag vs.129 · 108/bag; p = 0.025). Additionally, there wasa higher MNC yield/kg BW in collections on theCOM.TEC compared to the Amicus (2.7 · 108/kgvs. 2.1 · 108/kg; p = 0.013).

The median CD34+ cell concentration in collec-tions was higher on the Amicus compared to theCOM.TEC device (2126/lL vs. 886/lL; p < 0.001).There was a trend toward a higher median totalCD34+ cell count per component and per kg ofpatient’s body weight in collections on theCOM.TEC compared to the Amicus; however, theywere not significant (26.6 · 108/bag vs. 24.2 · 108/bag; p = 0.457 and 4.1 · 106/kg vs. 3.0 · 106/kg;p = 0.129, respectively) (Table 4). Additionally,there was statistical difference in terms of the meanCE of CD34+ cells between the Amicus and theCOM.TEC machines (51.0 ± 17.4% vs. 57.3 ±15.2%; p = 0.231) (Table 4).

COM.TEC p

20156 10,092 ± 1688 <0.001

50 (48–55) 0.004868 ± 176 0.019226 ± 41 <0.001

0) 300 (150–390) <0.001

COM.TEC p

0) 79 (48–247) 0.0080) 57 (35–192) 0.0066) 176 (111–480) 0.0256) 2.7 (1.6–8.9) 0.013–3752) 886 (512–2304) <0.0014.9) 26.6 (15.4–57.6) 0.4577) 4.1 (1.3–10.7) 0.129

57.3 ± 15.2 0.2311) 0.3 (0.2–2.5) <0.0015) 0.9 (0.5–7.4) 0.132

357 ± 132 0.6432) 1.1 (0.3–1.9) <0.001

ciency; PLT, platelet; Hb, hemoglobin; SD, standard deviation.

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Importantly, there was statistical difference interms of PLT contamination of products betweenthe Amicus and the COM.TEC device (0.3 · 1011

vs. 1.1 · 1011; p < 0.001) (Table 4). Additionally,although there was no statistical significance withrespect to the median RBC count of products percomponent between the Amicus and the COM.TECcell separator (1.6 · 106/bag vs. 0.9 · 106/bag;p = 0.132), the median RBC level of PBPC productswas higher in the Amicus than in the COM.TEC cellseparator (1.3 · 106/lL vs. 0.3 · 106/lL; p < 0.001).

3.4. Adverse effects of leukapheresis

We encountered no severe adverse effects necessi-tating interruption or cessation of the PBPC collec-tion process.

4. Discussion

Clinical outcome of patients with malignancy hasshown significant improvement with hematopoieticstem cell transplantation [1–6]. PBPC has essentiallyreplaced BM in restoring marrow function aftermyeloablative chemotherapy [1–4,7–9]. PBPCs canbe harvested using an automated blood cell separator[16–27,29,30]. Further, PBPCs can be collected safelyand efficiently by new cell separators, which increasethe number of CD34+ cells in the product, decreaseproduct volume, reduce the number of procedures,and improve the purity of the product. To date thereis only one published study concerning PBPC har-vesting with the COM.TEC machine [23]. Addition-ally, there is no published data comparing theCOM.TEC and the Amicus devices in terms of PBPCcollection. One of the problems which arise duringthe collection of PBPCs is the large volume of leuka-pheresis product that often requires volume reduc-tion prior to cryopreservation. A study comparingthe Amicus and the AS.TEC instruments showedthat blood volume processed was higher in PBPCcollections with the Amicus than with the AS.TECdevice (10,091 mL vs. 9895 mL), and separation timewas longer in the Amicus than in the AS.TECmachine (251 min vs. 236 min). However, the prod-uct volumes were not statistically different betweenmachines (129 mL vs. 111 mL) [27]. Ikeda et al.,compared the Amicus and the Spectra machine in aprospective crossover trial and reported that theAmicus took longer to process the same volume thandid the Spectra (p < 0.05) [25]. Schwella et al.,reported that the median blood volume processed

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was 12 L (10.7–13.3 L) with the COM.TEC deviceequipped with the MNC program [23]. In this study,the mean blood volume processed was significantlyhigher with the Amicus compared to the COM.TECcell separator (13,422 ± 2156 mL vs. 10,092 ±1688 mL) (p < 0.001). Therefore, the mean separa-tion time was significantly longer in the Amicus thanin the COM.TEC instrument (290 ± 30 min vs.226 ± 41 min) (p < 0.001). On the other hand, themedian product volume was significantly lower withthe Amicus compared to the COM.TEC instrument(125 mL vs. 300 mL; p < 0.001). This difference inproduct volumes may be associated with the develop-ment of the toxicity of dimethyl sulfoxide (DMSO),which is a cryoprotective agent, after infusion ofPBPCs product in patients in an autologous setting.Thus, one might expect that a decreased product vol-ume obtained by the Amicus would result in low fre-quency of DMSO-related toxicity because lesscryopreserved product with DMSO is to be infused.Therefore, the Amicus device may be selected toavoid the risk of DMSO-related toxicity in autolo-gous patients.

Schwella et al., reported that the median CD34+cells/kg BW was 5.5 · 106 with COM.TEC device[23]. Moog reported that the number of CD 34+cells in products was higher in the Amicus com-pared to the AS.TEC device (p = 0.056) [27]. Snyderet al., reported that the number of CD34+ cells/kgBW was higher with the Amicus compared to theCS 3000 machine (10.2 · 106 vs. 8.4 · 106), whenthe same blood volume was processed in patientswho did not have significantly different pre-aphere-sis CD34+ cell counts [21]. Ikeda et al., reported asimilar result for nucleated cell counts, CD34+ cellsand colony forming units with the Amicus and theSpectra machine [25]. In this study, althoughproduct volume was significantly higher with theCOM.TEC compared to the Amicus device, therewas no statistically significant difference betweenthe CD34+ cell count/kg BW for the Amicus andthe COM.TEC (3.0 · 106/kg vs. 4.1 · 106/kg) (p =0.129); this may be related to a more concentratedyield obtained with the Amicus device. Briefly, thisstudy showed that PBPCs could be efficiently col-lected with the COM.TEC and the Amicusmachines in patients in an autologous setting.

The other important challenge of PBPC collec-tion is PLT-related product contamination [1,2].The literature suggests that high PLT contamina-tion in progenitor cell concentrates results in signif-icantly lower CD34+ yield after immunoselection

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[31]. However, an increase of CD34+ cells in theproduct can be achieved by reducing PLTs in theproduct [31]. Additionally, the PLT contaminationof the products results in the PLT loss in PB; thisis important because these patients are often throm-bocytopenic due to their underlying disease and thechemotherapy used for PBPCs mobilization. Schw-ella et al., reported that PLT loss in patients withPBPC collected with the COM.TEC device was35.9% (19.2–66.1%) [23]. Ikeda et al., reported thatproducts collected by the Amicus had fewer PLTsthan those collected by the Spectra device (p <0.001); and, the decrease of patient PB PLT countswas more prominent using the Spectra than theAmicus instrument (p < 0.0001). They concludedthat the Amicus was superior to the Spectra in termsof apheresis-induced thrombocytopenia caused byPLTs contaminating the PBPC products [25].Snyder et al., reported that the PLT content of theAmicus collections was significantly lower than thatof the CS3000+ collections (4.35 · 1010 vs. 6.61 ·1010) (p < 0.05) [21]. Additionally, Jeanne et al.,reported that PLT contamination in Amicus com-ponents was twice as low compared to theCS3000+ [26]. In another study, the PLT contentof the products was lower in the Amicus than inproducts from the AS.TEC machine (0.17 · 1011

vs. 0.65 · 1011) (p < 0.001). In addition, the Amicusmachine resulted in lower PB PLT loss compared tothe AS.TEC device (12.5% vs. 34.4%) [27]. In thisstudy, PLT contamination of the products per com-ponent was higher in the COM.TEC (1.1 · 1011) ascompared to the Amicus cell separator (0.3 · 1011)(p < 0.001). Further, the median % decrease in PBPLT count was statistically higher in the COM.TECcompared to the Amicus device (18.5% vs. 9.5%)(p = 0.028). Therefore, in the collection of autolo-gous PBPCs, the Amicus cell separator may bepreferable to avoid PLT contamination, a decreasein PB PLT count, especially in patients withthrombocytopenia, and the risk of aggregation inPBPCs product because less PLT contained productis to be thawed while PBPCs are transfused topatients.

The volume of ACD used for anticoagulation isan important issue when comparing the machinesbecause the most common adverse effects duringthe procedures are ACD related [1,2,32,33]. Adversereactions such as tingling, cramps, chills, pallor, dia-phoresis, nausea, vomiting, flushed sensation,blurred vision, throat numbness and even tachycar-dia may be observed during the procedures [32].

Please cite this article in press as: Altuntas F et al., CompaTransf Apheres Sci (2007), doi:10.1016/j.transci.2006.10.008

McLeod et al., reported that the instrument usedfor the collection and citrate infusion rate influencedadverse reaction rates [33]. Schwella et al., reportedthat mild to moderate citrate reactions (perioral/limb paresthesias) were observed during 24.7% ofcollections with COM.TEC device [23]. It is reportedthat the median volume of ACD used was lower inthe Amicus compared to the AS.TEC device (911vs. 983 mL) [26]. In another study comparing theAmicus and the CS3000+ instruments, the twoinstruments used similar amounts of ACD (950 ±122 vs. 883 ± 159) [21]. Additionally, Ikeda et al.,reported that the volume of ACD used were equiva-lent between the Amicus and the Spectra (631 ± 192vs. 592 ± 135 mL) (p > 0.05) [25]. In the presentstudy, the mean volume of ACD-A used was higherin the Amicus compared to the COM.TEC cell sep-arator (1040 ± 241 mL vs. 868 ± 176 mL) (p =0.019). Further, we saw no severe citrate-relatedadverse reaction in patients on either device becauseall patients received calcium infusion during theprocedure.

In conclusion, our study suggests that a higheryield of PBPCs is collected with the Amicus andthe COM.TEC machines. However, the medianproduct volume is significantly lower with the Ami-cus compared to the COM.TEC device. The PLTcontamination of the products per component is sig-nificantly lower with the Amicus compared toCOM.TEC device. Further, the median % decreasein PB PLT count is higher in the COM.TEC com-pared to the Amicus device. For these reasons,autologous PBPCs collected from blood by theAmicus device may offer advantages over theCOM.TEC, e.g., the avoidance of PLT contamina-tion, a decrease in PB PLT count, and a large vol-ume PBPCs product.

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