Figure 2. Research strategy draft for clinical translation of tissue restoration in stroke.

After identification of the target patient population, a stroke model well reflecting this population is selected. The tissue restoration strategy, ideally combined with a supportive strategy, is then applied to this model in a basic (exploratory) efficacy trial. In the second step, the typical comorbidity and confounder profile of the target patient population is simulated in the stroke model for an advanced (confirmative) efficacy test, which should also include a thorough safety endpoint. If required, large animal modeling can be used for advanced safety assessments or therapy optimization before moving on to clinical investigations.