While China Pulls Ahead In Regenerative Medicine Research, Its Loosely Regulated Stem Cell Treatment Centers Raise International Concerns

BEIJING - China's ascendancy as a world power in regenerative medicine has been marked by a rapid-fire increase in the writing of top-level papers in the field for international scientific publications, but also by the appearance of controversial stem cell centers that sometimes offer treatments that have not been tested in clinical trials.

High-speed progress that Chinese scientists are making in terms of research and in generating human stem cell lines has been overshadowed to some degree by an international debate over the safety and efficacy of stem cell treatments now being provided across China, according to four scholars at the University of Toronto.

While these treatments are triggering a worldwide stem cell tourism phenomenon, attracting patients from across the globe, "there is no clinical trial evidence nor peer-reviewed research publications supporting these therapies," said scholars at the university's prestigious McLaughlin-Rotman Centre for Global Health.

The four Canadian scholars, Dominique McMahon, Halla Thorsteinsdóttir, Peter Singer, and Abdallah Daar, studied Chinese research and applications in regenerative medicine via an extensive review of international and Chinese publications and government papers, and through interviews with four dozen leading Chinese experts.

The University of Toronto scholars, who published part of their research recently in the British journal Regenerative Medicine , stated that Chinese leaders are pumping funds into stem cell research while sponsoring headhunting trips across North America and Europe aimed at snaring the top Western-trained Chinese scientists in the field.

But health regulators have failed to keep pace with the emergence of stem cell treatments across China, which "hurt the credibility of stem cell therapies in China," they said.

Since mid-2009, though, "stem cell therapies have been classified in China as a Category 3 medical technology, indicating they require proof of safety and efficacy by clinical trial," the Toronto scholars noted.

While characterizing China as "a rising scientific powerhouse in the field of regenerative medicine," the Toronto scholars also outlined the country's challenges in terms of the controversial stem cell treatments and regulatory oversight in an interview (Also see "China Emerging As World Power In Stem Cell Research" - Scrip, 29 Jan, 2010.).

PharmAsia News: In your study "Cultivating regenerative medicine innovation in China," you and co-authors from the University of Toronto state: "China has been able to catapult itself into the forefront of regenerative medicine but needs to address current regulatory challenges in order to secure its position in this emerging field."

What are the most important regulatory challenges China needs to address to secure its position?"

Peter Singer : The most important regulatory challenge for China now is ensuring the implementation of the new clinical regulation of stem cell treatments. In May, 2009, the Chinese Ministry of Health changed stem cell therapies to a Category 3 medical technology, which means that scientific evidence of safety and efficacy would be needed before making these therapies publicly available. To our knowledge, the Ministry of Health is still designing the criteria for stem cell therapies, and then will need to evaluate any available therapies against these criteria, so it will take some time to see how the enforcement of these new regulations change the current practices of stem cell therapy centers in China.

PharmAsia News: Do you project that China will increasingly leave behind it the controversy of the first phase of stem cell treatments that have not undergone clinical trials?

Abdallah Daar : Whether China is able to shed the controversy of its stem cell treatment centers, which offer unproven therapies, will depend largely on the adoption and implementation of its new rules surrounding the clinical use of stem cells. The international community needs scientific evidence that any clinically available stem cell therapies are safe and effective.

PharmAsia News: Do you think that Western press accounts of Chinese stem cell research have focused too much on stem cell tourism and neglected the real advances Chinese scientists have made in applied stem cell research?

Dominique McMahon : In the past decade, the Western media have focused on stem cell tourism in China. This focus on stem cell tourism has come at the expense of recognition of the scientific developments in China in this field.

Some Western scientists think stem cell tourism is the only thing going on in China, but our study shows that there is large amount of top-notch scientific research happening, making them the 5th largest publisher in the world on this topic in the international peer-reviewed literature.

PharmAsia News: You and the other co-authors of the study state: "The guidelines for embryonic research in China have generated international criticism. Because they are guidelines only, they have limited authority over researchers and are not legally binding."

Do you think it is vital for China to strengthen its regulations regarding stem cell research and treatments in order to restore international credibility?

Halla Thorsteinsdóttir : It is vital that China strengthens its regulations regarding stem cell treatments currently being marketed in order to restore international credibility. The safety of patients is a key concern both for China and the international community. It is essential that there be scientific evidence to support the efficacy and safety of regenerative medicine therapies as they are moved from the lab to the clinic.

International criticism of Chinese regulations has often unfairly lumped together research regulations and clinical regulations of stem cells. With respect to the research regulations for embryonic stem cells, we do not see a problem with the "liberal" or "permissive" nature of the regulations and our research indicates that most interviewees [among Chinese stem cell experts and policy makers] found these regulations to be adequate and binding.

These regulations have allowed researchers to pursue some types of research prohibited in other countries but are quite similar in nature to those of other countries, such as those in the United Kingdom. Our interviewees felt that these regulations may have given them an initial advantage in regenerative medicine. For example, due to the lack of cultural or religious opposition, embryonic stem cell research was allowed in China long before it received federal support in the United States.

One concern our interviewees pointed out is that these regulations are considered "guidelines" and not "law" and so have little regulatory oversight, and some interviewees felt improvements could be made to the implementation and enforcement of these regulations. We did not, however, find any evidence that would indicate that these regulations were not followed.

PharmAsia News: How important has the ability to attract Western-trained Chinese scientists back to China been in the overall advancement of stem cell research?

Peter Singer: The overall advancement of stem cell research in China has relied heavily on building up human resources by attracting Chinese researchers trained at the foremost stem cell research centres in the world.

Most of the top-notch scientists in China's regenerative medicine sector spent at least some time being educated abroad and many have extensive working experience in the public and private sectors in Western countries. We do believe that China's recruitment policy for overseas returnees has made an important contribution to regeneratve medicine, and could be a strategy for other developing countries to reverse the brain drain phenomena.

PharmAsia News: Back to your initial assessment - is it possible that China is on the road toward becoming one of the world's top powers in terms of applied stem cell research?

Abdallah Daar: China has placed a strong focus of its research towards developing new therapeutic applications in regenerative medicine for specific diseases. Researchers have now begun testing animal and human clinical trials for these new therapies, which are desperately needed globally.

There is no doubt that China is amongst the leading countries in the world in the race to develop regenerative medicine therapies.

Academic researchers in China have emphasized the development of therapeutic applications for stem cells. These are just beginning animal and human clinical trials, and it will be some time before they are available to the public.

This focus on application though, has allowed Chinese research to develop the expertise in applied science that will be needed to translate these therapies to the clinic, so they are well positioned to excel in product development. To do this successfully, they will need to overcome technical difficulties that may require more basic science, an area China has put little investment. They will also need to prove to the international community that any stem cell therapies that come out of this research are safe and effective using evidence based and scientific approaches.

- Kevin Holden ([email protected])