Long-awaited regulations may curb rogue clinics offering unproven treatments.
Chinese stem-cell scientists have welcomed long-awaited measures that, state media claim, will rein in rogue use of stem cells in clinics while allowing research.
The measures — announced on 21 August by China’s National Health and Family Planning Commission through state media — offer a straightforward path towards clinical studies, researchers told Nature. But some also warn that the measures do not have the teeth needed to stop clinics offering unproven and unapproved treatments.
For years, clinics around China have been ignoring government regulations and warnings from the scientific community, offering desperate patients costly and, according to experts, probably ineffective treatments. These were often labelled as clinical trials as a cover to charge patients. Other countries have experienced similar problems.
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In January 2012, the government took stock of the situation. It implemented a ban on unapproved stem-cell therapies and a temporary moratorium on new clinical trials, promising to establish a clear framework for future trials. Since then, however, many rogue stem-cell clinics have continued to operate, while stem-cell scientists with valid research agendas have waited for a way to move forward.
Many scientists have been itching to get started.
Qi Zhou, a stem-cell and cloning scientist at the Chinese Academy of Sciences (CAS) Institute of Zoology in Beijing, has been waiting for the guidelines so he can move his research from animal models to humans. In unpublished work, his team has already implanted dopamine-producing neurons derived from stem cells into monkeys that have been chemically induced to show symptoms similar to those of Parkinson’s disease. The monkeys have shown some improvement, and he now hopes to try the treatment on humans. “I think it’s time, time to start doing some clinical research,” he says.
http://www.nature.com/news/china-announces-stem-cell-rules-1.18252