State-announced regulations aim to rein in uncontrolled stem cell clinics and unregulated trials
In recent years, controversy has been building over the perceived malpractice of certain stem cell scientists and research centers across China. Previous reports have suggested that some clinics have been offering costly stem cell treatments to desperate patients despite insufficient evidence of their efficacy. Some of these therapies were being mislabeled as clinical trials in a bid to cover the activities but continue to charge patients.
The Chinese government first implemented a ban on the use of unapproved stem cell therapies in January 2012, at which time they also called a moratorium on new clinical trials, with the promise of establishing a clear framework to regulate the commencement of future trials. However, in the intervening years, a number of unregulated stem cell clinics are believed to have continued operating.
On 21 August 2015 a message from China’s National Health and Family Planning Commission, promising a straightforward path towards clinical studies, was announced through state media. The measures presented outline requirements for stem cell studies involving humans, including obtaining informed patient consent and requiring use of clinical-grade cells that have been approved for human use by an independent body. Clinical stem cell studies can only be performed at authorized hospitals and such studies cannot be advertised or paid for by patients. Pilot studies will also fall under new regulation, with the health ministry now requiring evidence that sufficient animal study data is available to support new human trials.
These new regulations have been largely welcomed by Chinese researchers. However Douglas Sipp, a policy researcher from the RIKEN Center for Developmental Biology, has expressed concerns over how the regulations will be followed. He explained: “In principle, I applaud any efforts to rein in practice of predatory clinics that take advantage of patients. But the fact that these new rules do not appear to have penalties leaves open the question of how effective they will be. I have seen China crack down on stem-cell clinics at least twice in the past, and the results were inconclusive.”
— Written by Hannah Wilson
Source: China announces stem cell rules. Nature News: www.nature.com/news/china-announces-stem-cell-rules-1.18252