STEMin1™ A Defined, Serum-free, Xeno-free medium for expansion of human stem cells w/L-Glutamine and Sodium bicarbonate Part A: Basal medium Part B: Growth Supplement

A Defined Serum free (SF) Xeno-free (XF) medium for in vitro culture of human mesenchymal stem cells. STEMin1™ meets special requirements including product specifications requiring a production process compatible with good manufacturing practice (GMP). Stem cells present multiple potential applications in regenerative medicine and are the subject of intense research. They constitute a very promising part of regenerative medicine and have many potential clinical applications. Harnessing their ability to replicate and differentiate into many cell types can enable successful treatment of diseases that were incurable until now. Therapeutic applications of MSCs requires a wide range of in vitro conditions that mimic their in vivo human conditions demands in order to reach appropriate cell numbers that can achieve therapeutic outcomes. Thus, identification of optimal culture conditions is a prerequisite for MSC clinical applications. Addition of fetal bovine serum (FBS) to culture media provides the cells with vital nutrients, attachment factors, and growth factors. However, utilization of animal derived products bears critical limitations and safety concerns, such as animal derived (Xeno) antigens and infectious agents present in FBS that can lead to a risk of infusion reactions and transmission of zoonotic diseases to the recipient of MSCs therapy. STEMin1™ is a serumfree xenofree alternative designed for in vitro culture of human mesenchymal stem cells. As an advanced therapy medicinal product, STEMin1™ meets special requirements includsing product specifications requiring a production process compatible with good manufacturing practice (GMP).