ABSTRACT
Ischemic Heart Disease (IHD) is the most prevalent cause of death worldwide. In recent years, cardiac stem/progenitor cell (CPC)-based therapies have emerged as one of the most promising treatments for IHD, due to their well-documented cardiac regenerative properties and the success of preclinical studies in small and large animal models. Although phase I and II clinical trials are already being conducted, several technological challenges still remain, including the lack of expertise on CPC manufacturing as well as on the identification of tools for characterization of cells’ quality attributes. This is imperative to ensure consistent generation of clinically relevant numbers of high quality cells to support phase III clinical trials and, ultimately, subsequent commercialization. In this chapter, we review and discuss the clinical relevance of CPCs and the methodologies currently being applied for isolation, culture and characterization of these cells, stressing the use of bioreactor systems for the expansion of CPCs in three-dimensional (3D) culture strategies and on the available analytical tools for cell-based product and process characterization.
