Mainland tightens rules on stem cell therapy

PUBLISHED : Tuesday, 10 July, 2012, 12:00am
UPDATED : Tuesday, 10 July, 2012, 12:00am
 

A member of the Chinese Academy of Sciences who helped draft the mainland's first regulations on clinical trials of stem cell treatments says the authorities are considering centralising such treatment and research in 50 hospitals and institutes.

Dr Wu Zuze said yesterday the Ministry of Health planned to select 50 hospitals and institutes as research bases. Other hospitals or research institutes that wanted to conduct clinical trials could only do so inside the 50 bases after their applications had been approved by the health authorities.

'A guidance note on clinical trials involving stem cell treatments and administrative rules on research bases have already been finished by the Ministry of Health and are expected to be released soon,' Wu said.

The move is part of a year-long crackdown on unscrupulous hospitals that had been cashing in on desperate patients with unproven therapies.

Launched by the ministry in January, the crackdown included a six-month ban on registering new stem cell projects.

Many foreigners have flocked to mainland hospitals for expensive but untested stem cell treatments that are offered far more freely than in the United States and other Western countries. Experts estimate several hundred hospitals and clinics are providing such treatments to mainland and foreign patients.

Ministry of Health spokesman Deng Haihua said in Beijing yesterday that although the ban on registering new stem cell projects had expired last week, unscrupulous hospitals and clinics would not be able to launch unproven treatments as easily as before.

'All unproven stem cell therapies launched by hospitals themselves have been halted,' he said. '[Given China's technology level], it's far from turning stem cells into clinical and other applications.

'The ministry and the State Food and Drug Administration (SFDA) are working together to draft regulations on clinical trials involving stem cell treatments.'

Deng said that only a few hospitals and research institutes were allowed to provide stem cell therapies after a joint team from the health ministry and SFDA, as well as provincial-level agencies, inspected regional hospitals, clinics and medical institutes.

In January, the ministry ordered that all unauthorised and unproved stem cell clinical trials and applications be immediately suspended, and that those approved by the SFDA should strictly follow the authorities' instructions, with changes to the trials and profit-seeking banned. It also said that all clinical trials should be free of charge.

Mainland media have reported that some patients died after receiving untested stem cell injections and some found their conditions worsened after receiving therapies that cost up to US$20,000.

Deng admitted at an earlier press conference that the health authorities had found many problems in the mainland's handling of stem cell treatments.

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For this many years, bone marrow, and more recently umbilical cord blood stem cells, have been used to treat leukaemia and lymphoma

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