The Chinese Ministry of Health is to introduce new regulations governing the use of stem cells in clinical therapies, according to the US journal Nature. They will come into force from 1 May 2009, and will place stem cell injections in the same Category 3 class of medical technologies as gene therapy, sex changes or surgical treatment for mental disorders. The Ministry will take direct responsibility for monitoring all such procedures.
Stem cells can be made to grow into many different cell types and could potentially be used to regenerate damaged tissues or organs. However, this area of medicine is still in its infancy, and the safety and effectiveness of new stem cell therapies remains unproven. Despite this, some clinics in China and elsewhere have already started offering stem cell treatments to patients.
Any Chinese institute that wishes to offer stem cell treatments will now have to prove they are safe through clinical trials, which must be approved by a regulator linked to the Ministry. If they fail, they must wait 12 months before reapplying. The penalties for not obeying the new rules have not been made clear but will probably include fines and/or the loss of their medical licence, according to Renzong Qiu, a bioethicist based at the Peking Union Medical College in Beijing.
There are worries that some institutes might get around the new rules by classifying their treatments as research, or that they will get approval from local government or their own review boards, which are not suitably qualified to assess the treatment. According to Qiu, there are between 100-150 clinics offering stem cell therapy in China. It is still unclear whether the companies providing the stem cells will also be monitored.
Beike Biotechnology is one such company, offering stem cells derived from both umbilical cords and adult tissues to 27 clinics worldwide. Their treatments are expensive and as yet unproven by clinical trials. They would not respond to any requests from Nature to comment on the new regulations or on the existence of any evidence to prove their therapies worked safely or not.
China was the first country to give governmental approval to gene therapy. It is hoped that 'these regulations will make people understand that the Ministry of Health and many scientists in China are concerned about these unverified procedures', says Ching-Li Hu, a paediatrician and senior adviser to Shanghai Jiaotong University's medical school.