Biodistribution of Mesenchymal StemStromal Cells in a Preclinical Setting
Joint Authors
Fleury-Cappellesso, Sandrine
Sensebé, Luc
Source
Issue
Vol. 2013, Issue 2013 (31 Dec. 2013), pp.1-5, 5 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2013-10-10
Country of Publication
Egypt
No. of Pages
5
Main Subjects
Natural & Life Sciences (Multidisciplinary)
Abstract EN
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.
American Psychological Association (APA)
Sensebé, Luc& Fleury-Cappellesso, Sandrine. 2013. Biodistribution of Mesenchymal StemStromal Cells in a Preclinical Setting. Stem Cells International،Vol. 2013, no. 2013, pp.1-5.
https://search.emarefa.net/detail/BIM-489728
Modern Language Association (MLA)
Sensebé, Luc& Fleury-Cappellesso, Sandrine. Biodistribution of Mesenchymal StemStromal Cells in a Preclinical Setting. Stem Cells International No. 2013 (2013), pp.1-5.
https://search.emarefa.net/detail/BIM-489728
American Medical Association (AMA)
Sensebé, Luc& Fleury-Cappellesso, Sandrine. Biodistribution of Mesenchymal StemStromal Cells in a Preclinical Setting. Stem Cells International. 2013. Vol. 2013, no. 2013, pp.1-5.
https://search.emarefa.net/detail/BIM-489728
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-489728