China stops unapproved stem cell treatments
BEIJING (Reuters) - 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.
(Additional reporting by Tan Ee Lyn in Hong Kong; Editing by Yoko Nishikawa)