In the United States, authorities have grappled with a surge of clinics selling therapies that are unsupported by evidence and, in some instances, have harmed people. In Japan, however, the proliferation of stem-cell clinics is different: it is sanctioned and promoted at the top echelons of government, thanks to a pair of regulatory acts designed to stimulate business and position Japan as a world leader in regenerative medicine.
Five years after Japan adopted these regulations, more than 3,700 treatments, including many based on stem cells, are on offer at hundreds of clinics across the country, and a wave of foreign companies has set up shop there.
Many companies, however, are taking advantage of the regulatory paths to avoid rigorous testing of their therapies and get them on the market fast. Scientists say that people who use them are probably not getting effective treatments. Most of the therapies approved for serious illnesses are supported by scant evidence, and there have been at least four reports of adverse events, including one death. Even government researchers and academic scientists who support the regulations say that changes are necessary.
Read full, original post: The potent effects of Japan’s stem-cell policies