BEIJING - China's top health authority will strictly regulate the cutting-edge stem cell treatment, which attracts thousands of patients from abroad each year, to ensure patient safety and the orderly development of the technology.
A one-year overhaul highlighting self-examination among practitioners will be launched to detect and eliminate irregularities surrounding the issue, said Deng Haihua, spokesman of the Ministry of Health at a news conference on Tuesday.
"All medical research and clinical practices of stem cell therapy without approval from the ministry and the State Food and Drug Administration will be put to an end after the overhaul," he told China Daily.
Largely due to concerns over ethics, treatment efficacy, and a lack of relative laws and regulations, the health authority has never approved clinical use of the therapy on the mainland, Deng stressed.
However, the demand and practice of the treatment have existed for a long time and are rapidly increasing, said Yang Jian, CEO of the Shanghai Medical Tourism Products and Promotion Platform.
Industry analysis shows that at least 10,000 patients from other countries come to the mainland for the costly procedure each year and roughly 100 facilities are offering the service.
Yang said some hospitals exploit regulatory loopholes to carry out the controversial therapy, which experts warn has no guarantee for safety and efficacy, he added.
In China, stem cell therapy is mainly used to treat diabetes, spinal cord injury, cerebral palsy, brain injury and stroke.
A nurse surnamed Qiao with the stem cell transplantation department of the General Hospital of Chinese People's Armed Police Forces told China Daily on Tuesday that they now have 80 patients, including 10 expats, undergoing stem cell treatment.
Since 2003, Qiao's department has treated more than 4,000 patients from 15 countries.
Asked how the overhaul would affect their business, she said because of the hospital's affiliation with the Armed Police, it would not be subject to management by the Ministry of Health.
Many hospitals with a military background are carrying out the therapy, said Qiu Renzong, a leading bioethicist with the Chinese Academy of Social Sciences.
To date, only adult stem cells sourced from bone marrow and umbilical cords for treating blood cancer have been proven safe and effective, he said.
More scientific data in terms of safety and efficacy is needed before stem cell treatment can be applied to humans, according to the World Health Organization.
Wang Qingyun contributed to this