History of the Brazilian Cellular Therapy Processing Group and initial survey on cellular therapy processing, quality control, and release criteria for cryopreserved peripheral blood stem cells in autologous transplantation
DOI:
https://doi.org/10.46765/2675-374X.2025v6n1e277Keywords:
Surveys and Questionnaires, Peripheral Blood Stem Cells, Cryopreservation, Transplantation, AutologousAbstract
There is considerable heterogeneity in peripheral blood stem cell (PBSC) cryopreservation protocols. In 2021, the Brazilian Cellular Therapy Processing Group was created to meet the need for technical specialists to exchange experiences, improve processes, and pursue international accreditation. This survey was developed to better understand national PBSC cryopreservation practices and to support the group’s technical discussions. An online questionnaire was created using Google Forms and disseminated. A total of 61 cell processing centers (CPC) responded to the survey. Most CPC showed interest in voluntary technical accreditation (n = 45; 73.8%), served one or two bone marrow transplantation units (n = 46; 75.4%) and processed bone marrow, PBSC and lymphocytes (n = 21; 34.4%). PBSCs were mainly cryopreserved within 24 hours of collection (n = 45; 73.8%), using a cryopreservation solution containing 5% DMSO and hydroxyethyl starch (n = 35; 67.3%). Most institutions froze and stored the cells at -80ÅãC until therapeutic use (n = 42; 80.8%). The maximum concentration of nucleated cells after cryopreservation varied widely across CPC. CD34+ cell quantification was most performed using the International Society for Hematotherapy and Graft Engineering dual-platform method (n = 25; 48.1%). The most frequently used post-cryopreservation quality control test was cell viability assessment using trypan blue exclusion (n = 34; 66.7%). This survey revealed considerable heterogeneity in PBSC cryopreservation practices among Brazilian CPC at the time the Cellular Therapy Processing Group was established. Since then, the group’s meetings have promoted improvements in the quality, safety, and efficacy of cell therapy products, as well as the gradual standardization of practices among its members.
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Copyright (c) 2025 Karen de Lima Prata, Andrea Tieme Kondo , Brian Custer , André Rolim Belisário
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