Chapter 19 - Regulatory Developments for Nonhematopoietic Stem Cell Therapeutics: Perspectives From the EU, the USA, Japan, China, India, Argentina, and Brazil

Abstract

This chapter explores regulatory developments for nonhematopoietic stem cell therapies in Japan, China, India, Argentina, Brazil, the USA, and the European Union. The chapter illustrates that the research methods, ethical standards, and approval procedures for the market use of nonhematopoietic stem cell interventions that have undergone an important process of global diversification. Section I introduces the regulatory conditions for nonhematopoietic clinical stem cell research and applications in each of the above countries. Section II discusses these findings and discerns three dynamics of regulatory diversification. Section III reflects on the advantages and disadvantages of different regulatory approaches across countries. The fourth and final section examines some of the roadblocks that presently prevent the clinical translation of nonhematopoietic stem cell–based therapies.