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@proceedings{901002,
author = {Foltánková, Veronika and Matějková, Eva and Smejkalová, Jana and Michálek, Jaroslav},
booktitle = {ISCT Europe 2nd Regional Meeting},
keywords = {mesenchymal stromal cells, clinical trials, GMP},
title = {Optimizing of bone marrow- and adipose tissue-derived mesenchymal stromal cells manufacturing for clinical trials},
year = {2010}
}
TY - CONF
ID - 901002
AU - Foltánková, Veronika - Matějková, Eva - Smejkalová, Jana - Michálek, Jaroslav
PY - 2010
TI - Optimizing of bone marrow- and adipose tissue-derived mesenchymal stromal cells manufacturing for clinical trials
KW - mesenchymal stromal cells, clinical trials, GMP
N2 - Mesenchymal stromal cells (MSCs) are nonhematopoietic multipotent cells displaying immunomodulatory, pro-angiogenic and reparative properties, and therefore are attractive sources for cellular therapy and tissue engineering. We optimized techniques for isolation of MSCs from bone marrow and adipose tissue, their expansion in humanized serum-free culture system, cryopreservation, transport, quality control and potency testing and established protocol for their manufacturing in validated GMP aseptic conditions in Clean Rooms. Controls of the production as contamination control and visual control of morphology and confluence are carried out during the cell expansion; cell number and viability are monitored at every cell harvest. To prevent the decrease of MSCs quality and proliferation rate, not more than 4 passages are performed. Release criteria take into account the effectiveness and safety of the product: cell number according to indication, 80% viability and immunophenotype fulfilling ISCT criteria and excluding impurities. MSCs from bone marrow and adipose tissue had similar morphology, immunophenotype and differentiation potential. MSCs from adipose tissue displayed higher proliferation rate and lower senescence ratio. Genetic stability was preserved even in higher passages. MSCs are resident in the source tissues in small numbers of nucleated cells, but can be readily expanded in vitro to provide sufficient number of GMP grade cells for local and systemic cellular therapy. Supported by the Ministry of Education of the Czech Republic, NPVII-2B06058, NPVII-2B08066 and endowment fund “Jistota“.
ER -
FOLTÁNKOVÁ, Veronika, Eva MATĚJKOVÁ, Jana SMEJKALOVÁ and Jaroslav MICHÁLEK. Optimizing of bone marrow- and adipose tissue-derived mesenchymal stromal cells manufacturing for clinical trials. In \textit{ISCT Europe 2nd Regional Meeting}. 2010.
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