Regenerative medicine and use of stem cells

Adult stem cells are nowadays considered as very promising approach for advanced cellular terapies for regenerative medicine with the aim to repair and/or to regenerate tissue functionality.

Adult stem cells are undifferentiated multipotent cells, able to give origin to different mature cell subsets.

Adult stem cells are present in differentiated tissues such as bone marrow, blood, adipose tissues etc.. they play a central role in maintaining homeostasis by generating new mature cells to increase tissue mass during pre and post natal growth and by replacing cell loss due to senescence or tissue damage.

In EU REG 1394/2007 and DIR 2009/120 CE advanced therapy products are more clearly defined and it is stated there that products for advanced therapies such as somatic cell therapy (including for example expansion of adult mesenchimal stem cells to be transplanted to cure several diseases) have to be produced in compliance with cGMP rules and guidelines.

According to principles described in cGMP, quality and safety of advanced cellular therapies need to be controlled by an appropriate “Quality Control” Unit independent from the Production Unit.

In this respect, Procelltech has implemented innovative quality Control assays to be applied to advanced cellular therapy products in compliance with cGMP requirements and validated in accordance to ICHQ2 guidelines.