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GMP-Compliant Expansion of Clinical-Grade Human Mesenchymal Stromal/Stem Cells Using a Closed Hollow Fiber Bioreactor

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Mesenchymal Stem Cells

Abstract

This chapter describes a method for GMP-compliant expansion of human mesenchymal stromal/stem cells (hMSC) from bone marrow aspirates, using the Quantum® Cell Expansion System from Terumo BCT. The Quantum system is a functionally closed, automated hollow fiber bioreactor system designed to reproducibly grow cells in either GMP or research laboratory environments. The chapter includes protocols for preparation of media, setup of the Quantum system, coating of the hollow fiber bioreactor, as well as loading, feeding, and harvesting of cells. We suggest a panel of quality controls for the starting material, the interim product, as well as the final product.

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Acknowledgments

We appreciate the excellent technical assistance of G. Baur, T. Becker, D. Erz, S. Chester, C. Späth, C. Loechelt, and A. Wachtel. This work was supported by grants from the 7th Framework Programme of the European Commission: CASCADE (Cultivated Adult Stem Cells as Alternative for Damaged Tissue) (HEALTH-F5-2009-223236), REBORNE (Regenerating Bone Defects using New biomedical Engineering approaches) (HEALTH-2009-1.4.2-241879) to Luc Sensebé and Hubert Schrezenmeier, the von Behring-Röntgen Foundation (Cellular Interaction of Nanoparticle-Labeled MSC with Tumor Cells), and the UKGM-Kooperationsvertrag Grant (GMP-conform manufacturing of MSC) to Cornelia Brendel and Holger Hackstein.

Financial Disclosure Statement

MTR and HS work for nonprofit organizations producing platelet lysate and clinical-grade MSC. BR and SB work for Terumo BCT.

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Correspondence to Markus Thomas Rojewski .

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Barckhausen, C. et al. (2016). GMP-Compliant Expansion of Clinical-Grade Human Mesenchymal Stromal/Stem Cells Using a Closed Hollow Fiber Bioreactor. In: Gnecchi, M. (eds) Mesenchymal Stem Cells. Methods in Molecular Biology, vol 1416. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-3584-0_23

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  • DOI: https://doi.org/10.1007/978-1-4939-3584-0_23

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-3582-6

  • Online ISBN: 978-1-4939-3584-0

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