We demonstrate the success of large clinical-scale culture of human adipose-derived mesenchymal stem cells in an industrial single-use vessel at a 3.75-L working volume. The vessel provides a precisely regulated environment for the growth of stem cells under carefully controlled simulated physiological conditions. The monitoring of the cultures allowed us to accurately regulate their performance, optimizing their growth while at the same time demonstrating appropriate stem cell markers coupled with differentiation assays performed at the end of the culture period. With a view to future cellular therapy exploitation, every step from initiation to conclusion in the expanded bioreactor vessel was performed with single-use disposables.

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