Stem-Cell Tests Must Show Success
May 30, 2018
(Nature) – As we report in a News story this week, Japan is set to push ahead with a promising treatment for heart disease that relies on stem cells. It could soon be made available under a fast-track approval system that the country put in place in 2014. Designed to speed access to regenerative therapies, the law allows prospective treatments to be marketed and used as long as they have been proved to be safe. Only a suggestion of efficacy is required — with more-convincing data supposed to be gathered retrospectively from patients who have been given the approved treatment. The system has its critics — Nature among them (see Nature 528, 163–164; 2015). The latest move adds further concerns.