China Halts Unapproved Stem Cell Treatments

As the industry for stem cell research grows, the Health Ministry has shut down unapproved stem cell treatments. The ministry is attempting to regulate the industry through this order and a year-long campaign against unauthorized stem cell therapy and trials. China has previously had a relatively relaxed policy on stem cell therapy trials. The Washington Post reports:

Stem cell therapies introduce new cells into damaged tissue in order to treat disease or injury. Patients, including some from overseas, can pay tens of thousands of dollars in a bid to restore such things as back functions or sight.

Ministry spokesman Deng Haihua told a news briefing that for stem cell tests already approved by the State Food and Drug Administration, “the clinical trials should not be altered and be charged for.”

Any unapproved stem cell research of clinical applications must be stopped immediately, Deng said, according to a transcript of the news briefing.

Despite the growing number of hospitals offering treatment, the ministry has stopped accepting new applications for treatments and clinical trials until July, but there is doubt that the government’s attempt to regulate the industry will be effective. Reuters adds:

Some of these involve large general hospitals where patients pay thousands — or even tens of thousands — of dollars for treatments that are advertised online, which attract both Chinese patients and those from overseas, sparking what experts say is a dubious type of medical tourism.

“One thing that is clear about the practice of stem cell medicine in China is that a lot of hospitals are affiliated with government organizations such as the army, the PLA, and the domestic police forces,” said Doug Sipp, a researcher into the ethics of stem cell applications at the RIKEN Center for Developmental Biology in Japan.

“I will be curious to see whether this combination of the Ministry of Health and the SFDA is capable of exercising or enforcing the regulations on hospitals which are affiliated with the Chinese government,” Sipp told Reuters by telephone.

Tuesday’s announcement is similar to one made in 2009 when China ordered hospitals and clinics offering advanced medical technology to obtain approval or face closure, Sipp said, adding that the order back then did not make much impact.

China’s stem cell industry began in 2007 and had fairly loose policies on research and trials. There is speculation that the government is attempting to make the products produced from stem cell research available overseas. Bloomberg adds:

China has adopted a four-way approach to build its stem- cell industry since 2007, including permissive policies on stem cells, recruiting back Chinese expatriates into local research, and providing annual funding of about $320 million, said Ipshita Chakraborty, a Calcutta-based industry analyst for Frost & Sullivan. A more stringent regulatory system will allow Chinese institutions to sell products overseas, Chakraborty said in a telephone interview.

“One industry shortcoming for a long time was a lack of a globally compliant regulatory system,” said Chakraborty, who tracks technology and investment opportunities in the stem cell space for the Mountain View, California-based consulting company. “The regulatory system is the most important, so if they focus on that, that’s good news for them: they’re putting focus on their investment in the right direction.”

Stem cells have the ability to become any type of cell in the human body, and researchers around the world are studying them to see whether they can cure disease. The potential of Chinese stem-cell research is high, Chakraborty said.

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