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Dendritic cells (DC) are the most potent antigen-presenting cells and form a promising new treatment modality. Fully activated DC loaded with antigen are very useful in stimulating immune responses, in particular those to combat cancer. Immature DC can either cause immunological tolerance or induce regulatory T-cells, opening up future application in transplantation, autoimmunity, and perhaps chronic inflammation. For these clinical applications, generation of DC under Good Manufacturing Practice conditions and without the use of animal products is a main prerequisite. To date, there are many different DC culture protocols, which subsequently lead to different types of DC. Protocols differ not only in DC preparation techniques, but also many other variables, like maturation status, dose and timing interval, route of administration, and antigen loading. DC vaccination, although very promising, is far from standardized. In this chapter we discuss the usefulness of standardized clinical and immunological criteria and the need for careful study design to further optimize the use of dendritic cells and to unequivocally prove their efficacy. [ABSTRACT FROM AUTHOR]