The Governance Of Stem Cell Translational Research

The current cutting-edge stem cell science brings people immense hopes and expectations. However, there are also many risks and uncertainties in the advancement of stem cell research, which continuously pose new challenges for the governance of stem cell translational research. This thesis argues that stem cell translational medicine is a complex technological system. The simple linear "from bench to bedside" translation model ultimately is not able to move biomedical knowledge acquired from laboratory to clinical application. Translational research not only has to solve intra-scientific hurdles, but also needs the co-production of science and social order. From the perspective of co-production, I argue that the success of stem cell translational research needs a mode of governance, and multiple interactions of different actors in the scientific/technological field, the medical/health field, the industrial-economic field, the legal-ethical, and the socio-political field to face various challenges. Based on this hypothesis, I build three separate translation models of the university research institutions, the stem cell companies, and the stem cell industrialization to analyze the Chinese cases. My case studies find that besides in-vitro development, animal studies, and clinical trials, the scientists in university research institutions have to look for resources out of laboratory; the stem cell companies need business models, and represent stem cells in the public; the stem cell industrialization must build an innovation system to make full use of the advantages of each sector. As a whole, they all need favourable political culture, reasonable healthcare system, public understanding of stem cells, meanwhile, try to deal with intellectual property rights, and to protect and respect patients and research participants. Finally, I propose some recommendations on how to govern stem cell translational research according to my designed models and first-hand interviews. China tends to be blamed as "Wild East" by Western countries for the lack of regulation and ethical governance in biomedical research. My case studies show that it is not the real fact. In China, as in other European countries and America, the stem cell translational research had lengthy uncertain regulatory context in the past, but the absence of state regulation has not led to a "Wild East" regulatory constellation, but rather to individualized regulatory strategies by a variety of stakeholders. The new regulation recently issued by China proves again that China has adopted efficient and legitimate strategies in bringing stem cell science to clinical application.