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cGMP-Compliant Transportation Conditions for a Prompt Therapeutic Use of Marrow Mesenchymal Stromal/Stem Cells

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Stem Cells and Good Manufacturing Practices

Part of the book series: Methods in Molecular Biology ((MIMB,volume 1283))

Abstract

We recently described conditions for safe 18-h manufacturer-to-patient transportation of freshly harvested hBM-MSC expanded under cGMP protocols using human platelet lysate (hPL), that allowed prompt use as an advanced therapeutic medicinal product. Here we outline important considerations when comparing different transportation conditions, highlighting that although cell transportation may involve a reduction in viability, this did not undermine the ultimate bone-forming regenerative potential of the cGMP-hBM-MSC population.

Author contributed equally with all other contributors.

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Acknowledgments

We are very grateful to the members of the European consortium REBORNE in providing the cGMP grade cells used to set up the protocol, in particular to Rosaria Giordano, Philippe Burin, and Hubert Schrezenmeier. We thank Biomatlante that provided the MBCP+â„¢ scaffolds. This work was supported by a grant (HEALTH-2009-1.4.2-241879) from the 7th Framework Programme of the European Commission REBORNE (REgenerating BOne defects using New biomedical Engineering approaches).

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    Authors and Affiliations

    1. Department of Medical and Surgical Sciences for Children and Adults, University-Hospital of Modena and Reggio Emilia, Via del Pozzo, 71, 41100, Modena, Italy

      Elena Veronesi, Jorge Sans Burns, Alba Murgia, Olivia Candini, Valeria Rasini, Ilenia Mastrolia, Fabio Catani, Paolo Paolucci & Massimo Dominici M.D.

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    1. Elena Veronesi
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    2. Jorge Sans Burns
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    3. Alba Murgia
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    4. Olivia Candini
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    5. Valeria Rasini
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    6. Ilenia Mastrolia
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    7. Fabio Catani
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    9. Massimo Dominici M.D.
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    Correspondence to Massimo Dominici M.D. .

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    1. Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

      Kursad Turksen

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    Veronesi, E. et al. (2014). cGMP-Compliant Transportation Conditions for a Prompt Therapeutic Use of Marrow Mesenchymal Stromal/Stem Cells. In: Turksen, K. (eds) Stem Cells and Good Manufacturing Practices. Methods in Molecular Biology, vol 1283. Humana Press, New York, NY. https://doi.org/10.1007/7651_2014_105

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    • DOI: https://doi.org/10.1007/7651_2014_105

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    • Publisher Name: Humana Press, New York, NY

    • Print ISBN: 978-1-4939-2434-9

    • Online ISBN: 978-1-4939-2435-6

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