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Translating Research into Clinical Scale Manufacturing of Mesenchymal Stromal Cells
Joint Authors
Karagianni, Marianna
Kinzebach, Sven
Bieback, Karen
Source
Issue
Vol. 2010, Issue 2010 (31 Dec. 2010), pp.1-11, 11 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2011-01-20
Country of Publication
Egypt
No. of Pages
11
Main Subjects
Natural & Life Sciences (Multidisciplinary)
Abstract EN
It sounds simple to obtain sufficient numbers of cells derived from fetal or adult human tissues, isolate and/or expand the stem cells, and then transplant an appropriate number of these cells into the patient at the correct location.
However, translating basic research into routine therapies is a complex multistep process which necessitates product regulation.
The challenge relates to managing the expected therapeutic benefits with the potential risks and to balance the fast move to clinical trials with time-consuming cautious risk assessment.
This paper will focus on the definition of mesenchymal stromal cells (MSCs), and challenges and achievements in the manufacturing process enabling their use in clinical studies.
It will allude to different cellular sources, special capacities of MSCs, but also to current regulations, with a special focus on accessory material of human or animal origin, like media supplements.
As cellular integrity and purity, formulation and lot release testing of the final product, validation of all procedures, and quality assurance are of utmost necessity, these topics will be addressed.
American Psychological Association (APA)
Bieback, Karen& Kinzebach, Sven& Karagianni, Marianna. 2011. Translating Research into Clinical Scale Manufacturing of Mesenchymal Stromal Cells. Stem Cells International،Vol. 2010, no. 2010, pp.1-11.
https://search.emarefa.net/detail/BIM-453421
Modern Language Association (MLA)
Bieback, Karen…[et al.]. Translating Research into Clinical Scale Manufacturing of Mesenchymal Stromal Cells. Stem Cells International No. 2010 (2010), pp.1-11.
https://search.emarefa.net/detail/BIM-453421
American Medical Association (AMA)
Bieback, Karen& Kinzebach, Sven& Karagianni, Marianna. Translating Research into Clinical Scale Manufacturing of Mesenchymal Stromal Cells. Stem Cells International. 2011. Vol. 2010, no. 2010, pp.1-11.
https://search.emarefa.net/detail/BIM-453421
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-453421