Washing transplants with Sepax 2 reduces the incidence of side effects associated with autologous transplantation and increases patients' comfort

Huvarová, Lucie; Kořístek, Zdeněk; Jelı́nek, Tomáš; Černá, Lucie; Smejkalová, Jana; Navrátil, Milan; Grebeníček, Lukáš; Tvrdá, Ivana; Michalíková, Magda; Hájek, Roman

doi:10.1111/trf.16566

Cited by 3 publications

(3 citation statements)

References 31 publications

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“…To avoid HPC losses as well as to reduce the risk of contamination, several techniques and methodologies have been developed for DMSO removal, replacing the conventional method which is based on manual removal after centrifugation [23]. An automated washing system, such as demonstrated by the present study, provides time sensitive alternative, optimizes the washing process and reduces the risk of contamination due to the closed fluid path 7, 16, 17. In 2011, Scerpa et al, showed that the automated washing procedure for DMSO removal, using the Sepax™ S-100 system, guarantees a better result in terms of recovering TNC, CD34 + /CD45 + cells and total CFU without affecting cell functionality, when compared to the manual centrifugation procedure 24 . In this study, the automated Sepax2™ system has proven an effective method for routine removal of DMSO from MPB cryopreserved grafts after thawing, with the mean recovery of TNC, viable CD34 + /CD45 + cells, CFU-GM count as well as maintaining test sterility of cell products.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of a Hydroxyethylstarch Solution for Dimethyl Sulfoxide Removal from Mobilized Peripheral Blood using an Automated System

MORAIS,

Dias,

Baiense

et al. 2023

jbmtct

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Background and objectives: This study evaluates the efficacy of synthetic colloid hydroxyethyl starch for use as a washing solution to remove DMSO from hematopoietic stem cells cryopreserved grafts in comparison to a crystalloid based solution. Materials and methods: We evaluated samples of cryopreserved mobilized peripheral blood (MPB) from 6 (six) patients that had not been used for transplant. For comparison, we used two equal bags of the same collection procedure, allowing the analysis of two different solutions simultaneously. Washing solutions were used: a crystalloid solution (solution 1, sodium chloride 0.9%) and a colloidal solution (solution 2, hydroxyethyl starch 6%), both added with human albumin 2.5%. The washes were performed using the SEPAX2™ (Biosafe) system automated methodology, using the CS-600.1 kit (Biosafe), according to the washing protocol established by the manufacturer. Results: The washing solution containing HES showed a statistically significant increase in the recovery of CNT and CD34+/CD45+ cells (p = 0.0313, both), in addition to a greater number of CFU-GM colonies (without statistical significance) when compared to the 0.9% sodium chloride solution. Furthermore, the wash solution containing HES also prevented significant clumping, contrary to what was observed in the wash with 0.9% sodium chloride solution. Conclusion: This work shows that the colloidal washing solution containing hydroxyethyl starch is a good option for DMSO removal procedures in samples of cryopreserved mobilized peripheral blood, maintaining the CD34+ cells viability and functionality and reducing the cell clumping.

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Section: Discussionmentioning

confidence: 99%

Evaluation of a Hydroxyethylstarch Solution for Dimethyl Sulfoxide Removal from Mobilized Peripheral Blood using an Automated System

MORAIS,

Dias,

Baiense

et al. 2023

jbmtct

View full text Add to dashboard Cite

show abstract

“…The apheresis‐collected product is cryopreserved until the time of infusion for almost all patients preparing for auto‐PBSCT and most patients waiting for allo‐PBSCT, whereas it is immediately infused without cryopreservation occasionally in allo‐PBSCT recipients 4,5 . For cryopreservation, an appropriate dose of cryoprotectant is added to the PBSC product based on its volume for prevention of cellular injuries, such as intra‐ and extracellular ice formation and cell dehydration, due to storage at temperatures below −80°C or with liquid/vapor nitrogen 6–9 . The most commonly used cryoprotectant for a PBSC product is dimethyl sulfoxide (DMSO), which is a hygroscopic polar compound that penetrates the cell membrane.…”

Section: Introductionmentioning

confidence: 99%

“…4,5 For cryopreservation, an appropriate dose of cryoprotectant is added to the PBSC product based on its volume for prevention of cellular injuries, such as intraand extracellular ice formation and cell dehydration, due to storage at temperatures below À80°C or with liquid/ vapor nitrogen. [6][7][8][9] The most commonly used cryoprotectant for a PBSC product is dimethyl sulfoxide (DMSO), which is a hygroscopic polar compound that penetrates the cell membrane.…”

Section: Introductionmentioning

confidence: 99%

Comparison of cryoprotectants in hematopoietic cell infusion–related adverse events

et al. 2022

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Background The standard cryoprotectant for human cellular products is dimethyl sulfoxide (DMSO), which is associated with hematopoietic cell infusion‐related adverse events (HCI‐AEs) in hematopoietic stem cell transplantation including peripheral blood stem cell (PBSC) transplantation (PBSCT). DMSO is often used with hydroxyethyl starch (HES), which reduces DMSO concentration while maintaining the postthaw cell recovery. The cryoprotectant medium CP‐1 (Kyokuto Pharmaceutical Industrial) is widely used in Japan. After mixture of a product with CP‐1, DMSO and HES concentrations are 5% and 6%, respectively. However, the safety profile of CP‐1 in association with HCI‐AEs has not been investigated. Study Design and Methods To compare CP‐1 with other cryoprotectants, we conducted a subgroup analysis of PBSCT recipients in a prospective surveillance study for HCI‐AEs. Moreover, we validated the toxicity of CP‐1 in 90 rats following various dose administration. Results The PBSC products cryopreserved with CP‐1 (CP‐1 group) and those with other cryoprotectants, mainly 10% DMSO (non‐CP‐1 group), were infused into 418 and 58 recipients, respectively. The rate of ≥grade 2 HCI‐AEs was higher in the CP‐1 group, but that of overall or ≥grade 3 HCI‐AEs was not significantly different, compared to the non‐CP‐1 group. Similarly, after propensity score matching, ≥grade 2 HCI‐AEs were more frequent in the CP‐1 group, but the ≥grade 3 HCI‐AE rate did not differ significantly between the groups. No significant toxicity was detected regardless of the CP‐1 dose in the 90 rats. Conclusions Infusion of a CP‐1‐containing PBSC product is feasible with the respect of HCI‐AEs.

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Sepax-2 cell processing device: a study assessing reproducibility of concentrating thawed hematopoietic progenitor cells

et al. 2022

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Background Autologous hematopoietic progenitor cell (HPC) transplantation is currently the standard of care for a fraction of patients with newly diagnosed myelomas and relapsed or refractory lymphomas. After high-dose chemotherapy, cryopreserved HPC are either infused directly after bedside thawing or washed and concentrated before infusion. We previously reported on the comparability of washing/concentrating HPC post-thaw vs. infusion without manipulation in terms of hematopoietic engraftment, yet settled for the prior favoring cell debris and DMSO removal. For almost two decades, automation of this critical step of washing/concentrating cells has been feasible. As part of continuous process verification, we aim to evaluate reproducibility of this procedure by assessing intra-batch and inter-batch variability upon concentration of thawed HPC products using the Sepax 2 S-100 cell separation system. Methods Autologous HPC collected from the same patient were thawed and washed either in two batches processed within a 3-4 h interval and immediately infused on the same day (intra-batch, n = 45), or in two batches on different days (inter-batch, n = 49) for those patients requiring 2 or more high-dose chemotherapy cycles. Quality attributes assessed were CD34+ cell recovery, viability and CD45+ viability; CFU assay was only performed for allogeneic grafts. Results Intra-batch and inter-batch median CD34+ cell recovery was comparable (75% vs. 73% and 77% vs. 77%, respectively). Similarly, intra-batch and inter-batch median CD45+ cell viability was comparable (79% vs. 80% and 79% vs. 78%, respectively). Bland-Altman analysis describing agreement between batches per patient revealed a bias close to 0%. Additionally, lower HPC recoveries noted in batch 1 were noted as well in batch 2, regardless of the CD34+ cell dose before cryopreservation, both intra- and inter-batch, suggesting that the quality of the collected product plays an important role in downstream recovery. Intrinsic (high mature and immature granulocyte content) and extrinsic (delay between apheresis and cryopreservation) variables of the collected product resulted in a significantly lower CD45+ viability and CD34+ cell recovery upon thawing/washing. Conclusions Automated post-thaw HPC concentration provides reproducible cell recoveries and viabilities between different batches. Implications of this work go beyond HPC to concentrate cell suspension/products during manufacturing of cell and gene therapy products.

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Washing transplants with Sepax 2 reduces the incidence of side effects associated with autologous transplantation and increases patients' comfort

Cited by 3 publications

References 31 publications

Evaluation of a Hydroxyethylstarch Solution for Dimethyl Sulfoxide Removal from Mobilized Peripheral Blood using an Automated System

Evaluation of a Hydroxyethylstarch Solution for Dimethyl Sulfoxide Removal from Mobilized Peripheral Blood using an Automated System

Comparison of cryoprotectants in hematopoietic cell infusion–related adverse events

Sepax-2 cell processing device: a study assessing reproducibility of concentrating thawed hematopoietic progenitor cells

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