Abstract
Clinical grade human mesenchymal stem cells (MSC) are manufactured and used in clinical trials for a range of regenerative and inflammatory diseases. Human MSC have now been derived from tissues other than bone marrow, such as placenta, as described in this laboratory protocol. It provides instructions for clinical grade MSC manufacturing according to the Code of Good Manufacturing Practice (cGMP) principles and according to policies and procedures of our internal Quality Management System (QMS), which is based on the International Organization for Standardization (ISO) standard requirements. Relevant organizational structure and QMS elements are presented.
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Acknowledgments
The authors would like to acknowledge funding from the Inner Wheel Australia, Mater Foundation and Mater Health Services for making this work possible.
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© 2011 Springer Science+Business Media, LLC
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Ilic, N. et al. (2011). Manufacture of Clinical Grade Human Placenta-Derived Multipotent Mesenchymal Stromal Cells. In: Vemuri, M., Chase, L., Rao, M. (eds) Mesenchymal Stem Cell Assays and Applications. Methods in Molecular Biology, vol 698. Humana Press. https://doi.org/10.1007/978-1-60761-999-4_8
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DOI: https://doi.org/10.1007/978-1-60761-999-4_8
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Online ISBN: 978-1-60761-999-4
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