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Title: Development and characterization of a clinically compliant xeno-free culture medium in good manufacturing practice for human multipotent mesenchymal stem cells
Authors: Chase, L.G.
Yang, S.
Zachar, V.
Yang, Z. 
Lakshmipathy, U.
Bradford, J.
Boucher, S.E.
Vemuri, M.C.
Keywords: Bone marrow stromal cells
Cellular therapy
Marrow stromal stem cells
Serum-free medium
Issue Date: 2012
Citation: Chase, L.G., Yang, S., Zachar, V., Yang, Z., Lakshmipathy, U., Bradford, J., Boucher, S.E., Vemuri, M.C. (2012). Development and characterization of a clinically compliant xeno-free culture medium in good manufacturing practice for human multipotent mesenchymal stem cells. Stem Cells Translational Medicine 1 (10) : 750-758. ScholarBank@NUS Repository.
Abstract: Humanmultipotentmesenchymalstemcell (MSC) therapies are currently being tested in clinical trials for Crohn's disease, multiple sclerosis, graft-versus-host disease, type 1 diabetes, bone fractures, cartilage damage, and cardiac diseases. Despite remarkable progress in clinical trials, most applications still use traditional culture media containing fetal bovine serum or serum-free media that contain serum albumin, insulin, and transferrin. The ill-defined and variable nature of traditional culture media remains a challenge and has created a need for better defined xeno-free culture media to meet the regulatory and long-term safety requirements for cell-based therapies. We developed and tested a serum-free and xeno-free culture medium (SFM-XF) using human bone marrow- and adipose-derived MSCs by investigating primary cell isolation, multiple passage expansion, mesoderm differentiation, cellular phenotype, and gene expression analysis, which are critical for complying with translation to cell therapy. Human MSCs expanded in SFM-XF showed continual propagation, with an expected phenotype and differentiation potential to adipogenic, chondrogenic, and osteogenic lineages similar to that ofMSCsexpanded in traditional serum-containing culture medium (SCM). To monitor global gene expression, the transcriptomes of bone marrow-derived MSCs expanded in SFM-XF andSCMwere compared, revealing relatively similar expression profiles. In addition, the SFM-XF supported the isolation and propagation of human MSCs from primary human marrow aspirates, ensuring that these methods and reagents are compatible for translation to therapy. The SFM-XF culture system allows better expansion and multipotentiality of MSCs and serves as a preferred alternative to serum-containing media for the production of large scale, functionally competent MSCs for future clinical applications. © AlphaMed Press.
Source Title: Stem Cells Translational Medicine
ISSN: 21576564
DOI: 10.5966/sctm.2012-0072
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