China
has ordered a halt to all unapproved stem cell treatments and clinical trials,
state media reported on Tuesday, as Beijing seeks to rein in the largely
untested stem cell therapies now on offer across the country.
The Ministry of Health will stop accepting new
applications for stem cell programs, a ban that will last until July and comes
as China begins a one-year program to regulate the sector better, Xinhua cited
a ministry spokesman as saying.
A growing number of hospitals and clinics in
large cities in China have been offering stem cell therapies for treatment of
diseases ranging from cancer and Alzheimer's to spinal cord injuries,
treatments that are backed by little or no scientific evidence and which are considered
at best experimental.
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.
According to patients, doctors and relatives
of patients who spoke to Reuters earlier, patients have come away with little
or no improvement and a number have died. Receipts seen by Reuters indicate
that one of these hospitals is run by the Chinese army, or Peoples' Liberation
Army (PLA).
The ministry spokesman said health providers
could no longer charge money for experimental stem cell applications under the
new order, which was jointly issued by China's State Food and Drug
Administration (SFDA).
CAN
IT BE ENFORCED?
Stem cell scientists and experts on medical
ethics welcomed the development but they questioned how the health ministry
could enforce the new order and reign in powerful arms of the Chinese
government, like the army.
"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.
Sipp said treatments were normally only
introduced after they have proven to be effective in clinical trials and
obtained approval from regulatory bodies.
"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.
The proliferation of unapproved stem cell
therapies is not confined to China.
Experts have raised the alarm about patients
turning up at clinics and hospitals in Mexico, India, Turkey, Russia and
elsewhere for stem cell therapies that have not undergone clinical trials and
are not recognized as standard treatment.
Last week, the United States' Food and Drug
Administration issued a warning about unproven stem cell claims.
"This is a positive news because there
has not been enough regulation, which damaged the reputation of this type of
research," said David Siu, a cardiologist and stem cell expert at the
University of Hong Kong.
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