Regenerative medicine is a fast growing multidisciplinary field aiming at the regeneration or replacement of damaged cells, tissues, or organs. Adult multipotent mesenchymal stromal cells (MSCs) are often used as a principal therapeutic tool in this field. Along with differentiation potency, MSCs secrete a wide spectrum of paracrine factors and extracellular vesicles participating in tissue repair and regeneration. Thus, for injuries that require trophic stimulation, cell survival support, and/or resident stem cells activation to be restored, one can apply MSC-conditioned medium, a combination of products and extracellular vesicles in cell culture growth medium, secreted by MSC. It could mediate most of beneficial regenerative effects of MSC without possible side effects of using MSC themselves. However, before the clinical application of this promising biopharmaceutical, several issues such as manufacturing protocols, quality control, and others must be addressed. Subsequently, we highlight the questions considering donor material variability, manufacturing, cell culture medium and auxiliary components selection, and potency tests development.
Part of the book: Biopharmaceuticals