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Quality Control for Mesenchymal Stromal Cells: Chondrogenesis as a Standard Condition?

Jana Müller, Jürgen Mollenhauer, Rocky Tuan and Karin Benz

Objectives: The application of mesenchymal stromal precursor cells (MSC) in clinical settings requires a pharmaceutical definition of cell quality including identity, purity, and potency of the individual preparations. In vitro chondrogenesis is presented to define identity and potency independently of specific laboratory conditions.

Methods: MSC obtained from 34 patients undergoing hip replacement surgeries were expanded and brought to chondrogenic differentiation in two laboratories in the USA and in Germany. Cell culture protocols were modeled along established procedures with local variations (primary isolation, serum, hormones, micromass and hydrogel cultures). Chondrogenic differentiation in micromasses and in hydrogel encapsulated cells was analyzed by mRNA quantification, and by determination of glycosaminoglycan content.

Results and Conclusions: The tested cell populations did not differ significantly in the patterns of differentiation between the two laboratories, indicating a strong genetic stability of the adaptive properties of the tested MSC. The results suggest that chondrogenesis may serve as a performance predictor in measures towards standardized quality control.