China attempts to halt unproven stem cell therapies
Peter Aldhous, San Francisco bureau chief
Are the Chinese authorities finally going to get a grip on the proliferation of unproven stem cell treatments being offered by clinics in the country?
On 10 January, the Ministry of Health announced a regulatory crackdown expected to take a year to complete. Spokesman Deng Haihua told the China Daily:
On 10 January, the Ministry of Health announced a regulatory crackdown expected to take a year to complete. Spokesman Deng Haihua told the China Daily:
"All medical research and clinical practices of stem cell therapy without approval from the ministry and the State Food and Drug Administration will be put to an end after the overhaul."
China isn't the only nation wrestling with the problem of unlicensed stem cell clinics - the announcement comes hot on the heels of the indictment in the US of four men alleged to have conspired in providing unlicensed stem cell treatments to patients at a clinic in Mexico.
However, the situation in China is a particular concern because of a blurring of the line between legitimate clinical research and a lucrative business offering unproven therapies to wealthy Chinese and stem cell tourists. As New Scientist reported in 2007, even some of the surgeons in a network set up to run clinical trials for spinal injury to the highest international standards were also charging other patients for treatments that had not yet been shown to work.
China has been investing heavily in stem cell research - last year an analysis by New Scientist indicated that it led the world in clinical trials of one of the most promising types of adult stem cells, known as mesenchymal stem cells.
While the review gets under way, there will be a moratorium on new applications to run stem cell trials until 1 July. According to an analyst quoted by Bloomberg News, China may want to put its regulatory house in order so that the treatments that eventually emerge can be sold overseas.
But this isn't the first attempt to regulate the "wild east" of stem cell medicine. In 2009, Chinese authorities similarly tried to prevent clinics offering unproven treatments. One problem is that many of the clinics involved are linked to hospitals run by the military and police. Douglas Sipp of the RIKEN Center for Developmental Biology in Kobe, Japan, who studies the regulation of stem cell medicine, told Reuters:
While the review gets under way, there will be a moratorium on new applications to run stem cell trials until 1 July. According to an analyst quoted by Bloomberg News, China may want to put its regulatory house in order so that the treatments that eventually emerge can be sold overseas.
But this isn't the first attempt to regulate the "wild east" of stem cell medicine. In 2009, Chinese authorities similarly tried to prevent clinics offering unproven treatments. One problem is that many of the clinics involved are linked to hospitals run by the military and police. Douglas Sipp of the RIKEN Center for Developmental Biology in Kobe, Japan, who studies the regulation of stem cell medicine, told Reuters:
"I will be curious to see whether this combination of the Ministry of Health and the [Chinese Food and Drug Administration] is capable of exercising or enforcing the regulations on hospitals which are affiliated with the Chinese government.
http://www.newscientist.com/
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