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Stem Cells International
Volume 2013 (2013), Article ID 678063, 5 pages
Review Article

Biodistribution of Mesenchymal Stem/Stromal Cells in a Preclinical Setting

1UMR5273 CNRS, UPS, EFS—INSERM U1031, STROMALab, Toulouse, France
2EFS Pyrénées-Méditerranée, Toulouse, France

Received 14 May 2013; Accepted 8 July 2013

Academic Editor: Mauro Krampera

Copyright © 2013 Luc Sensebé and Sandrine Fleury-Cappellesso. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Due to their multi/pluripotency and immunosuppressive properties, mesenchymal stem/stromal cells (MSCs) are important tools for treatment of immune disorders and tissue repair. The increasing uses of MSCs lead to the development of production processes that need to be in accordance with good manufacturing practices (GMP). In Europe, MSCs are somatic cell-therapy products, referred to as advanced-therapy medicinal products (ATMPs), and in the United States MSCs must comply with current good tissue practice requirements. The safety and efficacy of MSCs must be ensured, whatever the cell source, and studies of dose and biodistribution are important aspects of safety testing. Preclinical data on biodistribution and pharmacodynamics are mandatory for approval. It is important to demonstrate that MSCs do not have unwanted homing that could drive to inappropriate differentiation in some organ or to support cancer development as suggested in some experiments. All these aspects should be addressed in a risk-based approach according to recently published guidelines by EMA. In the present article, we summarize the main approaches for labeling and tracking of infused MSCs, report on current animal models, and give an overview of available results on biodistribution.