China plans legislation for clinical trials involving stem cells

Publié le 26 Aug, 2015

The Chinese Government wishes to regulate private clinics proposing stem cell treatments[1], the efficacy of which has not been proven. To this end, on 21 August 2015, it announced research legislation governing stem cell research. Some scientists are delighted at the announcement of “long overdue” measures whereas others, who are more pessimistic, worry whether these measures are sufficiently restrictive for “dishonest” clinics who “abuse affluent patients”.


As far back as 2012, the Government appraised the situation and took action against treatments that “had not been approved” or new “dubious” clinical trials. However, since 2012, some clinics have continued to welcome “desperate” patients and offer them “probably ineffective” stem cell treatments. Conversely, other scientists were waiting for these recommendations in order to embark on clinical trials.

The new measures govern patient information and authorise clinical trials solely in certain specialist hospitals.  Advertising is forbidden.  The new trials will have to be registered with the Ministry for Health.  The latter will check the relevance of the studies and results of pre-clinical studies (in animals).  At present, the penalties for scientists who violate the law have not yet been defined.


 [1] This refers to all stem cells (embryo, adult and iPS), used within the scope of regenerative medicine.

Nature (27/08/2015)

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