Biological validation of the stem cells product into bioreactor to use in clinical therapy.

The mesenchymal stem cells (MSCs) are in advance clinical testing for a number of indications and are entering clinical use for the repair and regeneration of a range of damage tissue and organs. The expansion of MSC to clinical therapy need of a scalable, automated and fully closed process. The overall objective of our project is to develop and validate a closed, aseptic automated system for the manufacture of therapeutic stem cells.

In this project we will implement the: i) in vitro characterization of the cell product to determine identity, purity, potency; ii) in vitro investigation of the cell secretome for verification of trophic therapeutic factors and their therapeutic potential; iii)in vivo ectopic validation of cell product in a subcutaneous mouse model and diabetic mouse fracture repair mode, respectively.