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.     

AutoPBSC程序与MNC程序采集外周血造血干细胞的比较研究

目的比较COBE Spectra血细胞分离系统的自动采集程序(AutoPBSC程序)与4.7版半自动采集程序(MNC程序)采集健康供者外周血造血干细胞的差异及对供者血常规相关指标的影响。方法 2002年3月~2008年3月期间对53例健康供者随机采用Auto PBSC程序和MNC程序进行了113例次造血干细胞采集,其中采用AutoPBSC程序63例次,MNC程序50例次。分析比较2种程序采得外周血造血干细胞(PBSC)的采集体积、单个核细胞百分数及总数、CD34+细胞百分数及总数等指标,采集前后供者红细胞、血小板变化。结果 2种程序采集外周血造血干细胞的体积、单个核细胞百分数、CD34+细胞百分数、CD34+细胞总数、采集袋中血小板及红细胞混入量、采集前后供者血小板计数的变化存在显著性差异(P<0.01);2种程序采集的单个核细胞总数无显著性差异;血小板计数在应用MNC程序组呈下降趋势,较AutoPBSC程序更加明显(P<0.01);1例地中海贫血供者应用Auto PBSC程序采集失败。结论 2种程序均可有效采集外周血造血干细胞,与MNC程序比较AutoPBSC程序具有以下优势:单个核细胞和CD34+细胞百分数提高、采集物体积减少有利于采集物的冻存、采集物中血小板数少对供者血小板影响小。地中海贫血供者需慎用Auto PBSC程序。     

Optimizing pediatric peripheral blood stem cell collection

IntroductionPediatric PBSC harvests pose specific challenges during apheresis and a knowledge of the same and variables affecting PBSC collection are very important in planning these procedures. In the present study safety profile of pediatric PBSC procedures and variables influencing the successful collection were analyzed.MethodPediatric PBSC harvest data for 3 years was reviewed for donor, procedural and product parameters and any specific challenges faced during the procedures. Successful PBSC collection was defined when CD34 dose obtained was ≥2 × 10⁶ cells/Kg of recipients’ body weight.Results85 PBSC collections performed on 46 children (age range 1.5–15 years) were included. Sixty-two procedures were on autologous donors and 23 on allogenic donors. The median CD34+ cell dose in the PBSC product per procedure was 2.12 × 10⁶ cells/Kg for autologous procedures and 4.6 × 10⁶ cells/Kg for allogenic procedures. Systemic adverse reaction was observed during only one procedure (0.01 %) and was managed conservatively. Successful dose was collected in 52 procedures (61.17 %) and was significantly associated with CD34+ count of more than 19.7/μL, monocyte count of more than 1.65 × 10⁶/μL, allogenic collection and female gender (p = 0.00001, p = 0.011, p = 0.00052, and p = 0.0001, respectively).ConclusionPBSC collection is safe in pediatric age groups and pre-procedure CD34 count of ≥20/μL on the day of collection may result in successful collection of stem cell dose. It is important to identify factors associated with failed collection for appropriate counselling and justifying pre-emptive use of stem cell mobilizing agents.     

Analysis of factors associated with low peripheral blood progenitor cell collection in normal donors

BACKGROUND: Predictive factors of the response to rHuG-CSF in normal donors have not been extensively studied. STUDY DESIGN AND METHODS: We analyzed factors influencing CD34+ cell yield in the 1st day of collection in 261 healthy donors from the Spanish National Donor Registry. The median age was 38 years (range, 2-72). The median dose of rHuG-CSF was 10 microg per kg per day (range, 5-20) over 4 days. In 103 donors (40%), <4 x 10(6) per kg CD34+ cells were collected. The variables that were analyzed included age, sex, weight, basal complete blood cell count, dose, type of rHuGCSF and schedule of administration, and maximum WBC count before apheresis. RESULTS: By univariate analysis, the maximum WBC count (<50 vs. >or=50 x 10(9)/L, p = 0.004), advanced age (p = 0.008), and number of daily rHuG-CSF doses (one vs. two; p = 0.01) correlated with the number of CD34+ cells collected. By multivariate analysis, donors age (<38 vs. >or=38 years; p = 0.014) and a single daily dose of rHuG-CSF (p = 0.005) were the two variables that significantly predicted a low CD34+ cell yield. CONCLUSION: Donors' age, with a threshold of 38 years or more, and the rHuG-CSF schedule are the factors that significantly affected CD34+ cell mobilization and collection in healthy donors.     

Peripheral blood stem cell collection: the interaction of technology, procedure, and biological factors

Centrifugal technology, continuous flow and discontinuous flow, has served as the technology platform for extracting cell concentrates of interest from peripheral blood (PB) for patient therapy for the past 35-40 yr. Models for procedure outcome exist for collection of normal donor (ND) platelet and granulocyte concentrates that integrate: (1) biological variables (pre-procedure PB cell concentration, the total circulating quantity of cells, donor/patient blood volume (BV)), (2) device efficiency, and (3) procedure parameters such as total blood processed (TBP), and in the case of cytoreductions - the volume collected. (cf. Hester J, Kellogg R, Mulzet A, et al., Blood (54) (1979) 254; Hester J, Ventura G, J Clin Apheresis (4) (1988) 188.) To date, no predictive CD34+ yield algorithm integrating these three variables has been formulated that could be applied prospectively for individual ND or patients (PT). There are economic, toxicity and statistical comparison benefits to be derived from generating such an algorithm.A small pilot study is presented with a brief review of current publications that suggest the circulating quantity of CD34+ cells available to be collected and the quantity mobilized during leukapheresis are the major contributing factors to CD34+ yield, somewhat obscuring the role of the total blood processed (TBP). Intraprocedure CD34+ cell mobilization, incompletely characterized to date, appears to be a dynamic nonlinear process, as the harvested yield does not rise proportionally as the fraction of BV processed increases. And, like the pre-procedure PB CD34+ concentration and total circulating quantity, CD34+ mobilization during leukapheresis probably relates to prior treatment and the priming regimen. Studies that provide: (1) separate analyses of PT populations divided according to chemotherapy toxicity factors; (2) design and implementation of optimal priming regimens with respect to dose 'intensity' of both growth factors and chemotherapy; and (3) standardization of laboratory assays of CD34+ enumeration seem essential to generating a predictive algorithm.     

Continuous Mononuclear Cell Collection (cMNC) protocol impact on hematopoietic stem cell collections in donors with negative collection predictors

Background

Recently, novel protocol utilizing Continuous Mononuclear Cell Collection (cMNC) have been introduced for leukapheresis. We compared the efficacy of cMNC with an older protocol – mononuclear cell collection (MNC) for CD34+ cell collection in unrelated donors with negative stem cell collection predictors.

An evaluation of predictive factors for CD34+ cell harvest yields from patients mobilized with chemotherapy and growth factors

BACKGROUND: Accurately predicting the outcomes of peripheral blood stem cell harvests is important because unproductive collections are expensive and subject the donor to unnecessary toxicity. STUDY DESIGN AND METHODS: Predictive factors for stem cell mobilization and collection by a retrospective review of 104 consecutive donors were evaluated. RESULTS: Of several previously suggested measures, the peripheral CD34+ cell concentration on the day of harvest (pCD34DH) correlated best with total numbers of CD34+ collected (r = 0.88). This was followed by the pCD34 on the day before harvest (pCD34Day -1) (r = 0.74). The peripheral WBC count on the day of harvest (pWBC) was inferior (r = 0.39). When ratios of potential predictive factors divided by the previous day's value were examined, pWBC ratio was found to be a significant independent predictive factor for cells collected (r = 0.45). Furthermore, the predictive value of both the pCD34Day -1 and the pWBC can be improved by combining with the pWBC ratio. To examine whether the chosen collection starting days were optimal, serial pCD34 obtained daily during the harvest procedures was examined. Poorly mobilizing donors, who required several days of collection, did not reach maximal harvest yields until the fourth collection day. CONCLUSIONS: pCD34DH is the optimal predictive factor for harvest yields. If pCD34DH is not available, pCD34Day -1 or pWBC combined with the pWBC ratio may offer the best prediction of harvest outcomes. The best harvest yields on poorly mobilizing donors occur 3 to 4 days after the usual collection starting times.     

Kinetic studies during peripheral blood stem cell collection show CD34+ cell recruitment intra‐apheresis

A sufficient number of CD34+ cells in the peripheral blood stem cell product is important to achieve a rapid and sustained engraftment. The purpose of the present work was to study CD34+ cell kinetics during leukapheresis. Blood samples before and after leukapheresis were analysed for CD34+ cells in 205 procedures. The number of CD34+ cells after plus the number of CD34+ cells harvested was 1.5‐fold greater than the number available at the beginning of the procedure, indicating recruitment of CD34+ cells during leukapheresis. In a subgroup of 66 procedures, granulocytes and platelets were measured. In contrast to CD34+ cells, these cell fractions were not recruited to the blood stream during leukapheresis. An additional nine patients were studied with serial blood measurements during leukapheresis, showing an initial decline that was followed by an increase in CD34+ cells during leukapheresis. In conclusion, CD34+ cells are recruited to the blood during the leukapheresis procedure in contrast to granulocytes and platelets. J. Clin. Apheresis. 16:114–119, 2001. © 2001 Wiley‐Liss, Inc.     

Platelet count is a sensitive predictor of autologous peripheral blood progenitor cell collection yield in previously treated plasma cell disease patients

BACKGROUND: It is often a clinical dilemma to determine when to collect autologous peripheral blood progenitor cells (PBPCs) in patients who received prior chemotherapy. It is also challenging to predict if the collected cells will be enough for one or two transplants. STUDY DESIGN AND METHODS: A total of 103 PBPC donors were followed to evaluate factors that predict poor autologous PBPC collection. The donors were categorized into three groups: plasma cell disorders (PCDs), lymphomas, and normal allogeneic donors. RESULTS: Our evaluation showed that platelet (PLT) count before growth factor administration significantly correlated with total CD34+ cell yield (Spearman r = 0.38, p < 0.001). Further analysis showed this correlation was only significant in plasma cell disease patients who received prior chemotherapy (Spearman r = 0.5, p = 0.008). Baseline PLT counts did not correlate with PBPC collection yield in untreated PCD, lymphoma, and normal allogeneic donors. In addition, daily PLT count during PBPC harvest correlated with CD34+ cell yield for that day (Spearman r = 0.41, p < 0.001). With a multiple linear regression model (adjusted R(2) = 0.31, AIC = 63.1), it has been determined that the baseline PLT count significantly correlates with total CD34+ cell yield in treated PCD patients. CONCLUSION: Baseline PLT count is a sensitive indicator of autologous PBPC mobilization in PCD patients who received prior chemotherapy. This finding may be considered before growth factor administration to determine the optimal period to mobilize treated PCD patients and to predict if enough cells can be collected for one or two transplants.     

Mononuclear cell variability and recruitment in non-cytokine-stimulated donors after serial 10-liter leukapheresis procedures

BACKGROUND: We introduced monitoring of mononuclear cell (MNC) counts to obtain enhanced donor control and a stable quality of MNC products, because there are limited data available about blood donors after serial leukapheresis (LP) procedures. STUDY DESIGN AND METHODS: In a prospective paired study, 13 male healthy blood donors underwent 10-L LP procedures performed on two apheresis devices by use of two MNC program settings (COBE Spectra, Gambro BCT, SF 250 vs. SF 500; and AS.TEC 204, Fresenius Hemocare, CP 129 vs. CP 194). Donors' pre- and postdonation MNC counts were analyzed by fluorescence-activated cell sorting. RESULTS: After each 10-L LP procedure, a transient decline (p < 0.05) of CD14+ monocyte and platelet counts appeared in donors. Loss of donors' CD3+ T cells, CD19+ B cells, and CD16+56+ natural killer (NK) cells during MNC collection was partly compensated by cell recruitment. The MNC recruitment factor (RF) seems to be higher with high-yield MNC program settings. Negative correlations (p < 0.01) were noticed between predonation counts and RFs of CD3+ T cells and CD16+56+ NK cells. Four serial 10-L LP procedures did not result in long lasting MNC depletion for donors. CONCLUSION: MNC recruitment seems to depend on MNC program settings and collected cell yields. Low MNC counts could result in high cell recruitment that may contribute to stable collection results to some degree. Nevertheless, there seems to be a considerable individual variation of MNC recruitment in donors that should be investigated in more detail.     

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.     

女性供者特征对粒细胞集落刺激因子动员的骨髓和外周血混合采集物中造血和免疫细胞组份的影响

目的 探讨女性健康供者特征对粒细胞集落刺激因子（G CSF）预激的骨髓和外周血混合采集物造血细胞和免疫细胞组份的影响。方法 111名健康女性供者应用G CSF动员,用流式细胞仪测定骨髓和外周血混合采集物中的CD34+细胞和T细胞亚群的数量,并分析怀孕、年龄、身高等供者特征对骨髓和外周血采集物中细胞组份的影响。结果 111例女性健康供者骨髓和外周血混合采集物中的CD34+细胞、CD3+T细胞、CD3+CD4+T细胞、CD3+CD8+T细胞和CD3+CD4-CD8-调节性T细胞的数量以每公斤供者体重计算的中位值分别为2.39×106/kg、226.57×106/kg、120.80×106/kg、89.99×106/kg和15.05×106/kg。①年龄对混合移植物中CD3+CD4-CD8-调节性T细胞的数量有影响。②体重指数（BMI）对混合采集物中的CD3+T细胞以及CD3+CD4-CD8-T细胞的数量有影响;③外周血干细胞采集当天的淋巴细胞（LYM）对混合采集物中的CD3+T细胞、CD3+CD4+T细胞和CD3+CD8+T细胞的数量有影响;④骨髓干细胞采集当天的LYM对混合采集物中CD3+T细胞和CD3+CD4-CD8-调节性T细胞的数量有影响;⑤与怀孕供者相比,未怀孕供者混合采集物中含有更高数量的CD3+CD8+ T细胞。结论 供者年龄、BMI、是否怀孕以及骨髓干细胞和外周血干细胞采集当天的LYM是骨髓免疫组份的主要影响因素。     

Matrix metalloproteinase-9 and cell kinetics during the collection of peripheral blood stem cells by leukapheresis.

The plasma levels of matrix metalloproteinase-9 (MMP-9) were determined during 41 collections of peripheral blood stem cells (PBSC) by standard volume (two blood volumes) leukaphereses (SVL) in 29 donors (7 allogeneic and 22 autologous) mobilized with the granulocyte-colony stimulating factor (G-CSF). The association between MMP-9 levels and cell counts in donor's blood was explored. During the processing of the first blood volume (BV), MMP-9 levels declined on average by 31% and persisted at the same level during the processing of the second BV. During the collection, a slight decline of white blood cells (WBC), polymorphonuclear neutrophils (PMN) and platelets (PLT) in donor's blood was accompanied by a significant drop of CD34+ cells by 37% after 1 BV and by 44% after 2 BV had been processed (p=0.001). The drop of MMP-9 plasma levels showed a loose correlation with the decrease of WBC (r=0.68, p=0.002) and PMN counts (r=0.67, p=0.001). We conclude that the levels of MMP-9 that have been elevated by the mobilization of donors with G-CSF, decrease during the collection of PBSC by 4h SVL. The observed decrease was indirectly related to the drop of WBC and PMN counts, suggesting that certain other factors have an influence on MMP-9 kinetics during PBSC collection.     

Analysis of factors associated with successful allogeneic peripheral blood stem cell collection in healthy donors

BackgroundThe collection of a sufficient number of stem cells is important for success of allogeneic hematopoietic stem cell transplantation (HSCT). This study aimed to investigate the factors associated with successful allogeneic peripheral stem cell (PBSC) collection in healthy donors.MethodsWe retrospectively reviewed clinical data of allogeneic PBSC collection in 175 donors from 2007 to 2017 at the National Cancer Center, Korea. This study analyzed factors associated with the CD34+ cell yield such as the characteristics of donors, including age, laboratory results before apheresis, and data of procedures on the first day. The CD34+ cell dose of ≥ 4.0 × 10⁶/kg have recently been the accepted minimum recommended dose in allogeneic HSCT settings, and this was the target dose in our study.ResultsThe factors associated with the CD34+ cell yield were age (p = 0.007), baseline platelet (PLT) (p = 0.014), and pre-collection hematopoietic progenitor cells (HPCs) (p = 0.001) by multivariate analysis. This study represented that age, baseline platelet count, and pre-collection HPC count are important predictive factors as shown in other previous studies.ConclusionOur data suggest that young age, high baseline platelet counts and high HPC counts before collection might be useful for identifying successful mobilizers.     

The use of hematocrit level for predicting the efficiency of peripheral blood CD34+ cell collection after G‐CSF Mobilization in Healthy Donors

Recently, peripheral blood stem cell (PBSC) has been widely used and replaced bone marrow (BM) as the stem cell source in allogeneic hematopoietic stem cell transplantation (HSCT) because of a more rapid engraftment, easier accessibility, and lower risk of donor complications. We, therefore, report the predicting factors for the high PBSC harvest yields in 50 healthy donors. Among the 50 donors, median collected CD34⁺ cell number was 4.6 × 10^6/kg (1.5–16.3 × 10⁶/kg). Number of circulating CD34+ cells and hematocrit (HCT) level increased parallelly whereas peripheral CD34+ cell numbers were decreased with increasing donor age. In univariate analysis, HCT level≥ 35.5% at the time of PBSC collection was significantly associated with high PBSC number (≥ 5.0 × 10⁶ cells/kg) and donor aged <30 years was significantly associated with collected CD34+ cells ≥ 6.0 × 10⁶/kg, P = 0.03. HCT level ≥35.5% was an independent parameter for high WBC count (≥50 × 10⁹/L), P < 0.05. None of donor who had both HCT < 35.5% and WBC < 50 × 10⁹/L had circulating CD34+ cells ≥ 5.0 × 10⁶/kg. Platelet count ≥ 200 × 10⁹/L was found significantly in donors with WBC ≥ 40 × 10⁹/L (P = 0.03) and HCT ≥ 35.5%, P < 0.05. Collected PBSC number tended to be higher in our donors with high levels of HCT, WBC, and platelet. We also found that HCT and platelet levels in our donors decreased after receiving G‐CSF administration compared with the initial complete blood counts (CBC) results. We, therefore, concluded that HCT level at the time of initiation leukapheresis was an important predictor for PBSC collection yields. J. Clin. Apheresis 30:329–334, 2015. © 2015 Wiley Periodicals, Inc.     

Peripheral blood stem cell collection in allogeneic donors: impact of venous access

BACKGROUND: Peripheral blood stem cell (PBSC) collection is accepted as a routine procedure in related and unrelated healthy donors worldwide. Venous access can be accomplished by peripheral veins or a central venous catheter (CVC). STUDY DESING AND METHODS: We compared efficacy and tolerability of 40 PBSC collections via CVC with 6267 PBSC collections via peripheral veins in healthy allogeneic donors. Results of the leukapheresis procedures and side effects in the donors were evaluated. RESULTS: The median CD34+ cell counts on Day 5 and the results of the stem cell collection were not significantly different between the two groups of allogeneic donors. Pain or problems at the site of puncture or catheter insertion occurred in 58.6% of the donors with a CVC versus 37.8% of the donors with peripheral venous access (p = 0.03). The incidence and severity of paresthesia during the leukapheresis was not significantly different in both groups of donors (p = 0.09). During follow‐up no major adverse events related to CVC were reported. CONCLUSION: Central femoral lines proved to be safe and tolerable in healthy allogeneic donors but peripheral venous access should be preferred, whenever possible.     

Peripheral blood stem cell collection and transplantation using the Haemonetics Multi Component System

AIM: To assess clinical usefulness of an intermittent-flow blood cell separator in peripheral blood stem cell (PBSC) collection and transplantation. RESULTS: The Haemonetics Multi Component System (Multi) was used to collect PBSC (52 aphereses in 17 patients). The mean processing blood volume and the mean PBSC yield were 7407 ml and 2.16 x 10(6) CD34+ cells/kg, respectively. When CD34+ cells exceeded 0.3% of the peripheral WBC, more than 2.0 x 10(6) CD34+ cells/kg could be collected by a single apheresis. Eight patients underwent PBSC transplantation after high-dose chemotherapy. Hematopoietic recovery was achieved in a median period of 10 days. CONCLUSIONS: (1) A single-arm, light-weight machine has sufficient capability to collect PBSC. (2) The percentage of CD34+ cells in the peripheral WBC is a good predictor of the CD34+ cell yield of the collection.     

Efficacy and safety of peripheral blood stem cell mobilization and collection: a single‐center experience in 190 allogeneic donors

BACKGROUND: In the past two decades peripheral blood stem cells (PBSCs) have increasingly replaced marrow as stem cells source for allogeneic transplantation. The PBSC donation initially applied only to related donors; later, due to the safety of the procedure, it was extended to unrelated donors. STUDY DESIGN AND METHODS: We have retrospectively collected data regarding mobilization, collection, and short‐ and long‐term follow‐up of 190 consecutive donors, 174 related and 16 unrelated. All donors followed a standard protocol for mobilization and underwent at least one PBSC collection. Follow‐up in related donors was performed every 4 months in the first year and then annually, with no time limits, while unrelated donors were monitored for 10 years. RESULTS: All 190 donors completed the established mobilization protocol. The mobilizing capacity was significantly greater in males and in donors less than 60 years old. No case of major toxicity by granulocyte–colony‐stimulating factor was found, nor thromboembolic events. The total dose of CD34+/recipient (median 5.8 × 10⁶/kg recipient/body weight) was statistically correlated with age, CD34+ before and after mobilization, and collection efficiency. Compliance to follow‐up was 66%, with a significant difference between related and unrelated (63% vs. 100%, p = 0.03). During follow‐up no significant abnormalities in hematologic variables or hematologic malignancies were reported. CONCLUSION: Our study allowed us to define the PBSC donation as “a safe procedure for the donors,” with short‐ and long‐term effects limited to a small percentage of donors and “effective for the recipient,” due to the dose of collected CD34+, adequate for transplantation in almost all recipients.     

PBPC collection techniques: standard versus large volume leukapheresis (LVL) in donors and in patients.

Transplantations of autologous and allogeneic peripheral blood progenitor cells (PBPC) are able to assure a complete hematopoietic and immunologic reconstitution in patients. PBPC are collected by leukapheresis technique after prior mobilization therapy, but procedures and results remain still highly variable and are poorly characterized. An optimum regimen for PBPC collections has not yet been recommended, but 2-3 total blood volumes (TBV) of the donor or patient are regarded as a standard. Another promising technique is large volume leukapheresis (LVL) with processing of 3-6 TBV of donor or patient. The aim of this paper is to find the most efficient and safe collection technique for an individual donor or patient and, consequently minimize the number of procedures required. Finding the optimal collection procedure would be helpful while considering which method would be preferred in an individual donor or patient with respect to the result of mobilization, health state and required yield of CD 34+ cells for transplantation. We evaluated the results in a total of 134 standard and LVL procedures, which were performed in 21 well mobilized donors (Group I), in 65 well mobilized patients (Group II), and in 14 weakly mobilized patients (Group III) with hemato-oncological diseases. A precollection concentration of CD 34+ cells in peripheral blood higher than 20 x 10(3)/mL was considered to be the criterion for efficient mobilization. Such levels of concentration indicating the start of PBPC collections could be easily reached in Group I of donors and Group II of well mobilized patients. Heavily pretreated patients at advanced stages of disease (Group III) did not respond to mobilization sufficiently and had a concentration of CD 34+ cells lower than 20x10(3)/mL. LVL technique made it possible to obtain higher numbers of CD 34+ cells than in the standard collection in well mobilized donors (Group I), well mobilized patients (Group II), and even in weakly mobilized patients in Group III. In donors and well mobilized patients (Group I and Group II) it was possible to collect sufficient amounts of CD 34+ cells for allogeneic or for autologous transplantation from one LVL collection. The median yield of CD 34+ cells from one LVL collection was 5.5 x 10(6)/kg b.w. in donors, and 6.0 x 10(6)/kg b.w. in well mobilized patients. Due to the linear dependence of the yield of collected CD 34+ cells on the concentration of CD 34+ cells in blood, it can be used as a simple prediction of the success of collection in Group II (correlation coefficient 0.93 for standard procedures, and correlation coefficient 0.88 for LVL). In Group III of weakly mobilized patients the standard collections were usually ineffective and the relationship between the yield of CD 34+ cells/kg in the product and the precollection concentration of CD 34+ cells was much less significant (correlation coefficient 0.56 for standard procedures and correlation coefficient 0.66 for LVL). The median of CD 34+ cells collected from one standard procedure was only 0.7 x 10(6)/kg but using LVL the median increased to 1.4 x 10(6)/kg. Our results prove that the yield of CD 34+ cells in the product can be enhanced by large volume leukapheresis (LVL). Based on the results obtained, we recommend LVL in all donors and patients who can tolerate it due to a greater chance of collecting higher yields of progenitor cells while minimizing adverse reactions. LVL procedures should also be preferred in weakly mobilized patients where it is not possible to collect sufficient amounts of CD 34+ cells for transplantation using the standard regime. In weakly mobilized patients LVL provides a greater chance to at least collect a minimum amount of CD 34+ cells necessary. LVL should be used in circumstances where extremely high doses of CD 34+ cells has to be prepared, e.g. planned "tandem" transplantations or manipulations with a graft in which a significant loss of cells is expected.     

Peripheral blood hematopoietic stem cell mobilization and collection efficacy is not an independent prognostic factor for autologous stem cell transplantation

BACKGROUND: The successful mobilization and collection of hematopoietic stem cells are dependent on a number of clinical factors such as previous chemotherapy and disease stage. The aim of this retrospective study was to determine whether the effectiveness of mobilization and collection is an independent prognostic factor for autologous stem cell transplantation outcome. STUDY DESIGN AND METHODS: A total of 358 patients who received transplants from January 2003 to December 2004 (201 male and 157 female patients, ages from 2.7 to 77.3 years with median of 53 years of age) underwent autologous hematopoietic stem cell collection after mobilization with granulocyte-colony-stimulating factor (G-CSF) or G-CSF plus chemotherapy priming. This retrospective study included patients with diagnoses of acute myelogenous leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, multiple myeloma, and solid tumors. All patients underwent stem cell collection until a target or a minimum CD34+ cell dose was reached. Correlations were performed between stem cell mobilization and/or collection efficacy and transplantation outcomes. RESULTS: In general, both larger reinfused CD34+ cell dose and shorter number of days for the stem cell count to reach the minimum of 2 x 10(6) per kg CD34+ cells do not foster quicker engraftment. Reinfused CD34+ cell dose of less than 12 x 10(6) and number of days stem cell collection to reach this minimum CD34+ cell dose did not independently affect the overall survival (OS) or disease-free survival (DFS). CONCLUSION: The effectiveness of hematopoietic stem cell mobilization and collection as defined as number of days to reach a CD34+ cell dose of 2 x 10(6) per kg should not be used independently to forecast posttransplantation prognosis, engraftment, DFS, and OS.