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The use of peripheral blood hematopoietic stem cells for bone marrow reconstitution after myeloablative therapy is well established in children with malignant disorders. However, the peripheral blood hematopoietic stem cells collection in very low‐body weight (≤10 kg) children remains a significant challenge because of technical and clinical issues. A male newborn affected by atypical teratoid rhabdoid tumor, diagnosed prenatally, received two cycles of chemotherapy following surgical resection. After an interdisciplinary discussion, it was decided to intensify the treatment with high‐dose chemotherapy followed by autologous stem cell transplantation. After 7 days of G‐CSF administration the patient underwent hematopoietic progenitor cells‐apheresis collection. The procedure was performed in the pediatric intensive care unit, using two central venous catheters and Spectra Optia device. The cell collection procedure was completed in 200 min, during which time 3.9 total blood volumes were processed. During apheresis we did not observe electrolyte alterations. No adverse events were recorded during or immediately following the cell collection procedure. Our report describes the feasibility of performing large volume leukapheresis without complications in an extremely low‐body weight patient weighing 4.5 kg using the Spectra Optia apheresis device. No catheter‐related problems occurred, and apheresis was completed without any adverse event. In conclusion, we believe that very low‐body weight pediatric patients need a multidisciplinary approach to manage central venous access, hemodynamic monitoring, cell collection, prevention of metabolic complications to improve safety, feasibility, and efficiency of stem cell collection procedures. [ABSTRACT FROM AUTHOR]

Background: Germ cell tumors represent, among solid cancers, a potentially curable disease even if up to 20% to 30% of patients (pts) relapse after first‐line treatment especially considering intermediate and poor prognosis groups. In this scenario, patients are candidates for high‐dose chemotherapy and autologous stem‐cells transplantation as second‐line treatment even though stem‐cells mobilization potential can be affected by several cycles and regimens of chemotherapy. To date, plerixafor is authorized in poor mobilizer adult pts diagnosed with lymphoma or multiple myeloma and in pediatric solid tumors or lymphoma. Therefore, the use of plerixafor in adult pts with relapsing/refractory GCT is still off label. Materials and methods: In our study, we describe mobilization and collection of peripheral blood stem cells for 10 pts with germ cell tumors. Six patients underwent plerixafor administration since classified as poor mobilizers based on WBC count (>5.000/μL) and CD34+ cell count (<15/μL) the day before apheresis procedure. Results: On the first day of apheresis, plerixafor administration in poor mobilizers made possible a remarkable boost of CD34+ cells in such a way to overlap that of good mobilizers' (32/μL vs 35/μL, respectively, P >.05). Conclusion: Therefore, in our experience, plerixafor made a good fraction of poor mobilizer patients eligible for mobilization and collection and able to undergo the predicted autologous stem‐cells transplantation; thus, the lack of access to the use of plerixafor in this setting of patients risks jeopardizing an effective treatment, especially in case of poor prognosis. [ABSTRACT FROM AUTHOR]

Background: Extracorporeal photopheresis (ECP) is an effective treatment for graft‐vs‐host‐disease (GvHD). Photopheresis can be performed in offline or inline method. The first uses a conventional cell separator for collection of mononuclear‐cells that are photoactivated by a separate device and manually reinfused; the second one involves a dedicated device performing the entire procedure (collection, photoactivation and reinfusion). Study design and methods: The objective was to compare the two methods and cell product features to highlight key process, devices performance, and to evaluate ECP clinical response. Patients developing steroid‐resistant GvHD underwent ECP as second‐line treatment using either inline (Therakos CellEx) or offline system (Terumo BCT Spectra or Optia and UVA PIT system). Data about patients' features, pre‐apheresis blood‐count, cell product characteristics and clinical response were collected for analysis. Results: We evaluated 494 procedures performed on 28 patients from April 2018 to March 2019. The offline procedure allows to achieve greater cell yield, it is characterized by larger processed blood volume, longer runtime, and higher ACD consumption. The inline procedure shows shorter runtime, high mononuclear‐cells percentage and low percentage of granulocytes in cell product. We observed a significant difference in cell yields between inline and offline system; furthermore we did not find a significant relationship between cell dose and clinical response. Conclusion: Inline ECP is fast, highly automated and productive, making it particularly suitable for ECP treatments. Offline ECP collects high cell yields implying longer procedure and greater operator intervention. Our study did not find a significant relationship between cell dose and GVHD response. [ABSTRACT FROM AUTHOR]

Background: Extracorporeal photopheresis (ECP) therapy has proved to be an effective and safe treatment for graft-versus-host-disease (GvHD), an important complication after hematopoietic stem cell transplantation. In 2016, we acquired Therakos CellEx, a dedicated inline ECP device to accomplish a significant increase in ECP activity. In literature, we found few data reporting CellEx performance evaluated in terms of collection efficiency to qualify the device. Hence, we decided to collect and analyze our data in order to build a reference in terms of expected results of the procedure. Here we report our data of ECP performed using CellEx in a 12-month period focusing on collection efficiency assessment, as well as procedural and apheretic product characteristics.Study Design and Methods: We collected data of patients undergoing ECP from April 2018 to March 2019 using CellEx in order to evaluate collection efficiency.Results: Between April 2018 and March 2019 we treated 28 adult patients affected by GvHD performing 319 ECP using CellEx. CellEx mononuclear cell product was characterized by high mononuclear cell percentage and low percentage of granulocytes, resulting particularly suitable for ECP treatments. Median collection efficiency for total nucleated cells and for mononuclear cells was 31.2% and 62.3%, respectively.Conclusion: Collection efficiency of CellEx was comparable to that usually obtained by cell separators designed for cell collection and was comparable to that of offline systems. Our results provide a detailed performance evaluation for inline ECP system users. [ABSTRACT FROM AUTHOR]

Background and objective: Extracorporeal photopheresis (ECP) is the most represented cell therapy for treatment of cutaneous T‐cell lymphoma, graft‐versus host disease and organ rejection. We analyzed our experience in ECP using 2 cell separators (Cobe Spectra and Spectra Optia) focusing on leukapheretic product characteristics, UV‐A irradiation procedure and entire ECP process. Materials and methods: We collected data of patients undergoing ECP between January 2012 and February 2015 in order to evaluate collection procedures performed using Cobe Spectra and Spectra Optia, mononuclear cell product, UV‐A photoirradiation procedure by Pit System. Results: We performed 484 ECP procedures in 27 patients. Cobe‐derived mononuclear cell products were characterized by higher cell yields while Optia‐derived mononuclear cell products were characterized by smaller volume, comparable mononuclear cell content but lower erythrocytes, granulocytes, and platelets contamination. Conclusion: Our study confirms good results for both cell separators. Blood volume processed being equal, Cobe collects a number of total nucleated cells significantly higher than Optia. Optia, collecting only target cells without significant erythrocytes, granulocytes and platelets contamination, is able to collect a leukapheretic product particularly suitable for ECP. [ABSTRACT FROM AUTHOR]

Background Study Design and Methods Results Discussion Extracorporeal photopheresis (ECP) has been demonstrated as an effective treatment for graft‐versus‐host disease (GvHD). The inline system was developed by Therakos in 1987. Recently, Fresenius Kabi implemented an integration of cell separator Amicus and a UVA photoactivation device (Phelix), realizing an inline photopheresis system.In 2022 we designed a prospective paired crossover trial (NCT05718674) comparing two integrated ECP protocols: Therakos CELLEX and Amicus ECP system. Twenty patients affected by corticosteroid resistant GvHD were submitted to 80 ECP, 40 paired procedures.All procedures were well tolerated, with no significant differences in procedure duration. CELLEX cell product showed higher granulocytes and platelet content, while Amicus cell product exhibited higher enrichment of lymphocytes, resulting in significantly higher MNC purity (92.9% vs. 84%).A significantly higher granulocytes and platelets absolute content was observed in CELLEX cell products, while Amicus cell products showed a significantly higher number of TNCs and MNCs. Differences in granulocyte and platelet content remained significant even after normalization of the data according to blood volume processed. These findings are confirmed by a statistically significant higher CE2% for CELLEX for granulocytes and platelets along with the lack of significant difference observed for TNCs and MNCs.Our analysis shows differences in the characteristics of the procedure and the cell product. Anyway, both devices are effective for performing ECP procedure, as they collect a cell product suitable for photopheresis. At present, our results represent the first data set comparing two available inline ECP devices. [ABSTRACT FROM AUTHOR]