Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations

In this article, we explore regulatory developments in stem cell medicine in seven jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the EU. We will show that the research methods, ethical standards and approval procedures for the market use of clinical stem cell interventions are undergoing an important process of global diversification. We will discuss the implications of this process for international harmonization and the conduct of multicountry clinical research collaborations. It will become clear that the increasing heterogeneity of research standards and regulations in the stem cell field presents a significant challenge to international clinical trial partnerships, especially with countries that diverge from the regulatory models that have been developed in the USA and the EU.Fil: Rosemann, Achim. Center For Education Studies; Reino Unido. University of Warwick; Reino UnidoFil: Bortz, Gabriela Mijal. Universidad Nacional de Quilmes. Departamento de Ciencias Sociales. Instituto de Estudios Sociales de la Ciencia y la Tecnología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Vasen, Federico. Universidad Nacional de Quilmes. Departamento de Ciencias Sociales. Instituto de Estudios Sociales de la Ciencia y la Tecnología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional Autónoma de México; MéxicoFil: Sleebom Faulkner, Margaret. University of Sussex; Reino Unid