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Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and Their Products According to Regulatory Requirements for FDA Approval

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Stem Cell Production

Abstract

Stem cells have unique properties that make them an exceptional source for regenerative medicine. Various types of stem cells and their products are used for therapeutic purposes, and they differ in their morphology, molecular markers, and functional characteristics. Nevertheless, to comply with regulatory requirements, strict criteria must be fulfilled. Here, we provide a comprehensive overview of the characterization criteria for human mesenchymal stem cells (hMSCs), human neural stem cells (hNSCs), human pluripotent stem cells (hPSCs), and human hematopoietic stem cells (hHSCs) that constitute the starting material for cell therapy products.

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Acknowledgments

This work was supported by the European Regional Development Funds—Projects ENOCH (No. CZ.02.1.01/0.0/0.0/16_019/0000868) and MAGNET (No. CZ.02.1.01/0.0/0.0/15_003/0000492). Supported by Ministry of Health of the Czech Republic, grant nr. NV18-08-00412. All rights reserved. Supported by the European Regional Development Fund—Project CZECRIN_4 PACIENTY (No. CZ.02.1.01/0.0/0.0/16_013/0001826). Tereza Souralova is a Brno Ph.D. Talent Scholarship holder and is funded by the Brno City Municipality.

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Correspondence to Irena Koutna .

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© 2022 The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.

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Souralova, T., Rehakova, D., Tesarova, L., Hampl, A., Koutna, I. (2022). Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and Their Products According to Regulatory Requirements for FDA Approval. In: Khan, F.A. (eds) Stem Cell Production. Springer, Singapore. https://doi.org/10.1007/978-981-16-7589-8_8

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