Journal of Tissue Science and Engineering

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

Abstract

Melanie L Hart, Juliane Brun, Katrin Lutz, Bernd Rolauffs and Wilhelm K Aicher

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.