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Latest status of the clinical and industrial applications of cell sheet engineering and regenerative medicine

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Abstract

Cell sheet engineering, which allows tissue engineering to be realized without the use of biodegradable scaffolds as an original approach, using a temperature-responsive intelligent surface, has been applied in regenerative medicine for various tissues, and a number of clinical studies have been already performed for life-threatening diseases. By using the results and findings obtained from the initial clinical studies, additional investigative clinical studies in several tissues with cell sheet engineering are currently in preparation stage. For treating many patients effectively by cell sheet engineering, an automated system integrating cell culture, cell-sheet fabrication, and layering is essential, and the system should include an advanced three-dimensional suspension cell culture system and an in vitro bioreactor system to scale up the production of cultured cells and fabricate thicker vascularized tissues. In this paper, cell sheet engineering, its clinical application, and further the authors’ challenge to develop innovative cell culture systems under newly legislated regulatory platform in Japan are summarized and discussed.

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Abbreviations

AFFSAPS:

Agence française de sécurité sanitaire des produits de santé

CAPS:

Cell Aseptic Processing System

CPC:

Cell Processing Center

ECM:

Extracellular matrix

EMA:

European Medicinal Agency

ESD:

Endoscopic submucosal dissection

FDA:

Food and Drug Administration

GMP:

Good Manufacturing Practice

iPSCs:

Induced pluripotent stem cells

KUH:

Karolinska University Hospital

LCST:

Lower Critical Solution Temperature

MHLW:

Ministry of Health, Labour and Welfare

MPA:

Medical Practitioners Act

PAL:

Pharmaceutical Affairs Law

PIPAAm:

Poly(N-isoproplyacrylamide)

PMDA:

Pharmaceuticals and Medical Devices Agency

PAT:

Process Analytical Technology

SOP:

Standard Operating Procedures

3-D:

Three-dimension(al)

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Acknowledgments

This work was supported by grants from the Global Center of Excellence Program, Multidisciplinary Education and Technology and Research Center for Regenerative Medicine (MERCREM), and Formation of Innovation Center for Fusion of Advanced Technologies in the Special Coordination Funds for Promoting Science and Technology “Cell Sheet Tissue Engineering Center (CSTEC)” from the Ministry of Education, Culture, Sports Science, and Technology (MEXST), Japan, the Japan Society for the Promotion of Science (JSPS) through the “Funding Program for World-Leading Innovative R&D on Science and Technology (FIRST Program),” initiated by the Council for Science and Technology Policy (CSTP).

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Egami, M., Haraguchi, Y., Shimizu, T. et al. Latest status of the clinical and industrial applications of cell sheet engineering and regenerative medicine. Arch. Pharm. Res. 37, 96–106 (2014). https://doi.org/10.1007/s12272-013-0299-8

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  • DOI: https://doi.org/10.1007/s12272-013-0299-8

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