A Stem-Cell Race That No One Wins

September 26, 2019

(Nature) – It is five years since Japan passed laws regulating stem-cell clinics; in that time, some 3,700 treatments have received the green light. From Hokkaido to the islands of Okinawa, companies in Japan can extract stem cells from skin biopsies and use them in injections for complex conditions such as heart disease. But the vast majority of these therapies have not passed a randomized, controlled, double-blind clinical trial, the global standard to prove that interventions are safe and effective, and the foundation for most medical regulation. Instead, Japan’s 2014 Act on the Safety of Regenerative Medicine and a second law, the 2014 Pharmaceutical and Medical Device Act, provide a fast track to market approval.