offer stem cell therapies in China.
The Ministry of Science and Technology in conjunction with the Ministry of Health issued ethical guidelines for human embryonic stem cell research in 2003. As in most countries, reproductive cloning was forbidden. Embryos for stem cell research must originate from voluntarily donated germ cells, gametes or blastocysts spared from in vitro fertilization procedures, blastocysts obtained by somatic cell nuclear transfer, or fetal cells from terminated pregnancies (whether by abortion or miscarriage). While funding is more limited than in the West, many costs are significantly lower.
Stem cell research does not face the same taboo in China that it does in many other nations. While Western researchers contend with the idea, espoused by Catholicism and many other Christian denominations, that a human embryo is a human life, the Confucian worldview dominant in China explicitly rejects this and states that life begins at birth. The Chinese government has perceived an opportunity to make up for decades of lagging behind the West by doubling down research in an area the West has thus far found ethically complicated. Regenerative medicine is one of China’s primary focuses in medical research, and by 2008 China was the fifth-largest source of stem cell research papers.
Untested stem cell therapies vary in their specifics, but they generally boil down to the same approach: treating the injection of stem cells into a patient as a panacea, one the efficacy of which is dependent on the stem cells developing into exactly the right kind of cells the patient needs to remedy his condition. Despite the proven efficacy of stem cell therapies in many contexts, this magical-thinking approach to medicine not only threatens to bilk patients and insurers, but casts a pall on the reputation of legitimate stem cell therapies and researchers. Further, many untested stem cell therapies are offered for conditions that have no other reliable cure or treatment, which complicates things when other, legitimate treatments for those conditions become available. One famous patient receiving untested stem cell therapy in China was supermodel Janice Dickinson, who subsequently sued the Rite Aid corporation in 2013 for the cost of her stem cell treatment for damage to her neck, shoulder blades, back, and knee, after she slipped and fell in a Rite Aid parking lot.
One of the most well-known providers of untested stem cell therapies in China is Beike Biotech, which has marketed extensively online and promised stem cell treatments for conditions including cancer, spinal cord injury, cerebral palsy, arthritis, autism, and baldness. According to a 2012 study of Canadian medical tourists, Beike’s hospitals in China and Thailand had treated 900 foreign patients. One patient spent about $33,000 ($30,000 of which went to Beike, the rest on travel expenses and incidentals) for four weeks of treatment consisting of six stem cell injections for multiple system atrophy. Like many other hospitals offering untested treatments, Beike made no guarantee of positive results, and the patient’s atrophy continued to progress, after short-term improvement that was ascribed to the physiotherapy she received in conjunction with the stem cell injections.
Prior to the institution of new regulations in 2012, the legal infrastructure surrounding stem cell therapies in China was so uncertain that science journal Nature reported in 2010 that during its investigation into Beike Biotech, chief executive Alex Moffett requested that the journal direct him to any formal applications for Ministry of Health approval for his company, since he was unaware of whether they existed. While investigations in years previous of other Chinese government agencies had uncovered numerous problems with corruption, in the case of Chinese stem cell treatments, corruption simply wasn’t necessary because there were too few official obstacles in their way.
Medical tourism has threatened the reputation of Chinese research, by conflating all Chinese stem cell work with the unproven therapies unscrupulous institutions sell to wealthy Westerners. The recent regulations have been an attempt to respond to this, although the repercussions for violating them are mild. Under the regulations, stem cell therapy is categorized as “category 3 medical technology,” the same category as sex-reassignment surgery, gene therapy, and surgical treatment of mental illness. Medical institutions offering category 3 treatments must first demonstrate their effectiveness in clinical trials, as well as the safety of their protocols and procedures. However, the fines for noncompliance can be as little as a few hundred dollars.
In 2013, Children’s Hospital Los Angeles conducted a study on children with optic nerve hypoplasia who had received stem cell therapies in China. Interestingly, the study was requested in part by Beike, who needed to test the efficacy of its therapy in order to comply with new Chinese regulations. Optic nerve hypoplasia is the leading cause of pediatric blindness in the West, as well as the only cause of pediatric blindness that is becoming more common: an effective treatment for it would indeed be a medical breakthrough. The Children’s Hospital study compared 10 children who received stem cell therapy from Beike with controls. The Beike patients received six infusions of mesenchymal stem cells over 16 days, and daily infusions of related medications. No improvement to visual acuity, optic nerve size, or pupil response to light was found one month, three months, or nine months after treatment.
In 2009, researchers at the Chinese Academy of Sciences and Shanghai Jiao Tong University produced fertile mice from inducible pluripotent cells, which offered the possibility of conducting stem cell research without embryos, and of growing replacement organs from a patient’s tissue sample. Further research on making induced pluripotent stem cells as versatile as embryonic stem cells was pursued at Peking University and published in a 2013 paper in Science. The method uses chemical injection rather than the gene insertion method previously in use. Ten thousand small molecules were screened in search of a combination that would be as effective as gene insertion without introducing new complications. Small molecules have the benefit of passing easily through cell walls without affecting the immune system. Because they can easily be synthesized and standardized, they’re also cost-effective. Screening and fine-tuning took several years before a cocktail of seven small compounds was shown to convert.2 percent of adult tissue cells into inducible pluripotent stem cells, the same conversion rate found in gene insertion. As of the paper’s publication, work had only been done on mice, and work remained to be done to demonstrate the utility of the process with human tissue.
Stem cell research has been instrumental in reversing some of the brain drain China has experienced in the past. Brain drain is a phenomenon commonly experienced in the developing world as well as in less prosperous or urban regions within the developed world, in which local young men and women, educated at local expense, leave for the West (or within the West, for the big cities) either to continue their education or to pursue a job that pays better or offers better opportunities than they can find at home. Brain drain can slow the progress made in improving the scientific community and research infrastructure of a country, as the best students keep leaving for other countries instead of remaining and continuing to contribute to the growing community. In China’s case, new investments in stem cell research have led Chinese-born scientists who had been working or educated abroad to return to China to pursue their research. Joy Zhang, in her work The Cosmopolitanization of Science, uses Chinese stem cell research—and the boom in Asian biotech in general—as an example of the way “globalization” is not always “westernization.” “The development of China’s stem cell research,” she argues, “exhibits neither linear globalization as ‘China becoming the West’ nor simple globalization as ‘global research with Chinese characteristics.’ Rather, it is a cross-border dialectic process in which existing Chinese characteristics are being reiterated and transformed. Concurrently, this transformation from a developing country alters the global research paradigm” (Zhang, p. 3).
Bill Kte’pi
Independent Scholar
See Also: Beike Biotechnology; Japan; Korea; Peking University; Taiwan.
Further Readings
Aldhous, Peter. “China Attempts to Halt Unproven Stem Cell Therapies.” New Scientist, January 11, 2012.
