Fraudulent cell therapy. South Korea, trying to restore its tarnished image in the field, increases safety regulations
South Korea has been trying to restore its tarnished image in the field after the fall of one of its stellar stem-cell scientists, Woo Suk Hwang, who was convicted in 2009 for embezzlement and bioethics violations after falsifying results. The country has begun to regain confidence from a series of successful research projects, and is ranked in the world’s top ten for stem-cell and regenerative medicine research in terms of number and quality of publications. The South Korean government thinks that the country can be a top global competitor if the field is given enough support.
It is known that cell therapy is not free from risks (see our article on fraudulent cell therapy), and that possibilities are sometimes offered that do not comply with minimal safety regulations. In an attempt to avoid cell therapy fraud, South Korea has amended its safety regulations for the use of drugs that use stem cells, obliging manufacturers to meet strict requirements for their production and thus avoid potential risks, while following rigorous safety protocols when they are to be used in patients. These regulations will come into force in 2017 (Nature Biotechnology 34; 125, 2016).