Schematic outline of functional therapeutic approaches for stem cell based-therapy. Development of therapeutic approaches for stem cell-based therapy in consideration of the parameters to be optimized and validated for beneficial clinical outcome. The preliminary approach of the selection of most potential stem cell source (autologous or allogeneic) is followed by characterization for the physicochemical, biological, pharmacokinetics and pharmacodynamics properties of these cells at in vivo and in vitro levels before clinical trials. To further enhance the therapeutic potential of these cells at clinical trial stage, certain concepts from pharmaceutical drug therapies like preconditioning, co-administration, route of delivery, dose and duration of treatment is to be optimized and validated for more effective outcomes. Therapeutic benefits like bioavailability, bioequivalance, targeted delivery and dose associated disease response are to be anticipated by such clinical approaches to enhance the efficacy of the treatment.