Stem-Cell Nanoengineering from Bench to Bed:
Regenerative medicine is an emerging field of medical practice applying recent advances in material science: engineering and stem-cell research to find solutions for healing of diseased or damaged tissue employing the body's own healing mechanisms. Within this field, regeneration of biological tissues happens through using human stem cells merged by supporting structures and/or bioactive biomolecules. Despite the great success of the field, current techniques used in stem-cell research hardly resemble the physiological complexity of the stem-cell niches. Employing nanoengineering allows development of novel, precise, and standardized tools that capture physiological details, resulting in greater control of stem-cell fate and the corresponding nanoengineered stem-cell products. These products are expected to have a considerable impact on medical practice as well as enhancing patients’ quality of life. Nevertheless, currently these products largely fall outside the scope of current legislation both in Europe and the United States. Detailed requirements and guidance have not yet been established thoroughly and the approaches taken by different countries vary. The aim of this chapter is to assess the status of stem-cell therapeutic products from regulatory approval and public perception perspectives. Short descriptions of the currently available nanoengineered stem-cell products or prototypes, as well as the role of nanostructures in clinical tissue regeneration, are also provided.