ABSTRACT
The advancement of regenerative medicine (RM) has become a popular goal. It is promoted and supported by patients, healthcare providers and governments in an effort to reduce the growing medical and fi nancial challenges in healthcare. This chapter aims to provide a general overview of the ethical, legal and social issues (ELSI) associated with regenerative medicine, beginning by defi ning the term and briefl y summarizing the state of the industry. It discusses issues arising from the use of human cells, challenges of clinical translation, and questions of social justice that emerge from innovations in the fi eld. Lastly, the chapter will turn its focus to the role of the regulatory system in managing the progress and development of regenerative therapies. It will review the ways in which select jurisdictions have adapted existing frameworks to incorporate product development in regenerative medicine, specifi cally cell-based and combination products, into their regulatory regimes. The chapter then considers elements important to creating a regulatory environment conducive to responsible innovation and international harmonization in RM.
