China is forging ahead to conduct human clinical trials of treatments using the CRISPR gene-editing tool, the Wall Street Journal reports. The first CRISPR trial began in China in 2015, while the first outside of China, likely to be at the University of Pennsylvania, has yet to begin, it adds.
The Journal says that researchers in China have fewer regulatory and other considerations to address prior to setting up and beginning trials than researchers in the US and Europe. Wu Shixiu at Hangzhou Cancer Hospital has been using CRISPR to treat, for instance, esophageal cancer patients only had to seek approval from his hospital ethics board, which the Journal notes is largely equivalent to an institutional review board in the US. Carl June at Penn, meanwhile, sought an assessment by a National Institutes of Health advisory committee — which asked for some changes before approving the study — before then entering discussions with the Food and Drug Administration as well as his hospital IRB. The Journal says June is expected the OK from the FDA this month.
While June tells the Journal that there is "regulatory asymmetry" between the US and China, he adds that "it is hard to know what the ideal is between moving quickly and making sure patients are safe" because CRISPR gene editing is untried.