Mesenchymal Stem Cell Manufacturing for Clinical Use

Abstract

Mesenchymal stromal/stem cells (MSCs) are adult, self-renewable, multipotent cells that can be isolated in various tissues, most commonly bone marrow (BM) and adipose tissue. Because of their capacity for self-renewal and differentiation into tissues of mesodermal origin and due to their immunomodulatory ability, MSCs are used in many preclinical and clinical studies as possible new therapeutic agents for the treatment of a very broad range of conditions, including heart, hepatic, and neurodegenerative diseases. Whatever the tissue of origin or the clinical application, the MSCs must be expanded in vitro to obtain sufficient cell numbers, also when multiple doses are needed. The MSC manufacturing process for clinical use should comply with the principles of Good Manufacturing Practice (GMP). This ensures that cell preparations are produced and controlled, from the collection and manipulation of raw materials, through the processing of intermediate products, to the quality controls, storage, labelling and packaging, and release. The application of GMP to manufacture medicinal products such as MSCs must ensure that clinical trials are unaffected by inadequate safety, quality, or efficacy arising from unsatisfactory manipulation of the cells.