alexa Do we Need Standardized, GMP-Compliant Cell Culture Pro
ISSN: 2157-7552

Journal of Tissue Science & Engineering
Open Access

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Review Article

Do we Need Standardized, GMP-Compliant Cell Culture Procedures for Pre-Clinical In vitro Studies Involving Mesenchymal Stem/Stromal Cells?

Melanie L Hart1, Juliane Brun1, Katrin Lutz1, Bernd Rolauffs2 and Wilhelm K Aicher1*

1 Department of Urology, Eberhard Karls University, Germany

2 Siegfried Weller Institute for Trauma Research, BG Trauma Clinic, Eberhard Karls University, Germany

Corresponding Author:
Wilhelm K Aicher
Department of Urology
Eberhard Karls University
Tuebingen, Germany
Tel: +49 70712987020
Fax: +49 70712925072
E-mail: [email protected]

Received date: March 05, 2014; Accepted date: March 24, 2014; Published date: March 26, 2014

Citation: Hart ML, Brun J, Lutz K, Rolauffs B, Aicher WK (2014) Do we Need Standardized, GMP-Compliant Cell Culture Procedures for Pre-Clinical In vitro Studies Involving Mesenchymal Stem/Stromal Cells? J Tissue Sci Eng 5:135. doi:10.4172/2157-7552.1000135

Copyright: © 2014 Hart ML, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author andsource are credited.



At present worldwide there are more than 350 clinical trials involving human Mesenchmal Stem/Stromal Cells (MSC). These trials involve the regenerative potential of hundreds of diseases or syndromes. However, only approximately 10% of the conditions explored are investigated in more than 10 clinical trials, while most of the maladies are investigated in 3 trials or less worldwide. In addition, the MSCs used in pre-clinical studies versus those used in the clinical trials are produced by variable procedures. In the majority of conditions under investigation the outcome of the studies is therefore cumbersome to evaluate. Standardizing in vitro cell culture procedures for definition and production of MSC could help to facilitate the evaluation of these cells in the clinical context, especially in those clinical trials that are minimally addressed. We advocate consistent Good Manufacturing Practice (GMP) compliant procedures for production of MSC in the context of all pre-clinical experiments, especially since clinically, GMP-compliant production of cells is the standard anyway.


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