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Controversy shakes stem cell research in China

Doubts about the application of biomedical therapy of Chinese origin are growing

In only eight years, Chinese researchers have multiplied by 30 the number of articles on stem cells and regenerative medicine in scientific journals of international scope and already publish more than Canada or Australia. With 1,116 articles in 2008, they are in fifth position, behind the United States, Germany, Japan and the United Kingdom.

Malén Ruiz de Elvira | 2 February 2010


Photo: The Journal of Cell Biology
During these years the Chinese government has taken a great leap forward in R&D, as it has multiplied the investment by eight approximately and is financing as a priority the areas of stem cells, tissue engineering and gene therapy , and also decides how it is spent. The public financing, which is the main part, is much directed to the development of applications and clinic products. 78% of the money intended for regenerative medicine is reserved for the development of products and 16,8% to applied research.
 
The outlook is bright for the Asian giant but this fast growth is not without problems, according to the members of an institute of the University of Toronto (Canada) where they analyze China's situation in this field with first hand data. For their analysis they have met with researchers, regulators, politicians, doctors and business managers. The result is the first detailed analysis of China as emerging power, as explained by the signatories of the study McLaughlin-Rotman Centre for Global Health, published in the journal “Regenerative Medicine”.

Success without results

The main problem the researchers refer to is an implantation of therapies and products without concluding results. One example is gene therapy. In China the first ones to be commercialized in the world have been approved, intended to reduce the size of head and neck tumours and respectively destroy tumour cells. Some Chinese researchers believe that it has all gone too fast, without waiting to have clear evidence on its medical benefits exceeding those from other therapeutic options.

The fact that the Chinese advance in stem cells may be due to more permissive and non-mandatory regulations has been criticized Another case is the high number of hospitals (more than 200) that do stem cell therapies mainly developed by companies, whose efficiency is not proven although it increases the medical tourism each year. They are treatments for a wide range of diseases, going from ataxia to diabetes, Parkinson, autism or multiple sclerosis. "There are no results of clinical trials or scientific articles revised by pairs to endorse these therapies”, the authors of the study affirm. In May 2009 the government regulated them by law and since then clinical trials are required before their application, but until now the situation doesn't seem to have changed much.  

Spinal cord injuries constitute one of the most controversial and important focuses of the Chinese efforts in regenerative medicine.  In an institute in Beijing they inject foetal cells as treatment and have published results in international journals, but they are inconclusive. Once more, the efficiency on humans is not proven.

Doubts about the regulation

Some scientists of other countries have criticized that the Chinese advance on stem cells and regenerative medicine, in their opinion, might be due to the regulating in this field being more permissive than in other countries and not mandatory. The authors of the study report that it is not quite like that, as the regulations are very similar to the ones applied in the United Kingdom, a bit more permissive than the Spanish.

In the Asian country therapeutic cloning is allowed, the usage of discarded embryos or those from abortions, as well as the ones created through cloning. However, contrary to most part of the countries, in China a type of cloning which implies the fusion of human genetic material with animal eggs is also allowed. Nevertheless, reproductive cloning, research with embryos older than 14 days, fertilization between different species and implantation in human or animal uterus of embryos created for research are not allowed. 

But there are more differences, and they are cultural this time. In Chinese culture, the notion of an embryo being a person is out of place “so that the creation and use of embryos are not constrained by the so discussed ethical problems like in other places of the world", the authors explain.

There are other potential problems in the horizon. Some Chinese scientists are of the opinion that applied research is being promoted too much and the development to the detriment of basic research, to which in all areas an average of 5.2% come from the R&D budget, and that in short term this defect will stop applications. An important example is that not much is being done in trying to know about the control bases of the differentiation of stem cells.

BETWEEN SCEPTICISM AND SUSPICION The current situation in China is based on an already long tradition in research on reproduction and animal cloning which started in 1963 when Dizhou Tong cloned a carp, the first fish and second animal to be cloned in the world. Another important factor in the last years has been the recovery for the country of a high number of scientists formed abroad and the building of large primate facilities.

However, the fast growth of the results about regenerative medicine in China still causes certain scepticism in the rest of scientific powers, including for the journals having to publish them. In part this scepticism is due to the increase in the number of cases of misconduct, plagiarism and fraud discovered in the last years and in the lack of confidence in the official mechanisms of approval for new therapies and drugs. The researchers know that without international recognition, it is as if their work would not exist, but the problems are major. “It is the Yin-Yang of a scientific power mixed with controversial clinical applications of stem cell therapies”, says Peter A. Singer, director of the McLaughlin-Rotman Centre. “The scenario is currently ambiguous, but in the future, given the measures that are being implanted, it is expected that science will increase and controversy will diminish.”

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