Consigned to a wheelchair and rapidly losing motor functions, 9-year-old Kara Anderson, who suffers from cerebral palsy, faced an uncertain future in her native US. With doctors recommending invasive surgery that would sever tendons, nerves and ligaments to help restore mobility, her family began searching overseas for alternatives.
After months of research, her uncle David Mair, who is also CEO of a medical tourism company, suggested stem cell therapy in China. This largely experimental field of medicine uses undifferentiated (or “blank”) cells that can take on the functions of depleted or damaged cell lines and repopulate within the patient’s body. While many stem cell treatments remain years, if not decades away from being approved as safe in the West, a combination of more lenient regulations and a distinctly different model of medical ethics has seen a surge of these advanced procedures in China over the past decade.
With her options limited at home, Anderson traveled to a medical center in Beijing where she was injected with approximately fifty million stem cells harvested from umbilical chords. The treatment was combined with medication and physical therapy to direct the cells to areas where they could begin to repair and repopulate. The improvements exceeded even the most optimistic of expectations, according to Mair, who accompanied his niece to China.
“Since [Kara’s] treatment she now has independent use of her left arm and can use her hand for most major motor functions,” he explains. “She only uses a single crutch to get around and, on occasion, doesn’t use one at all. She can’t thread a needle but then again, neither can I.
“She has improved coordination and motor skills. The only downside is that in the four years since treatment she’s needed to have her glasses replaced three times, but that is only because of improvements in her vision.”
While medical tourism for advanced treatments has traditionally seen people traveling to the West for the latest technology and leading physicians, the flow of patients is reversed in the field of stem cell medicine. In 2010 it was estimated that there were over 200 clinics and hospitals across China administering experimental treatments for a range of chronic and degenerative conditions, including Parkinson’s disease, multiple sclerosis and muscular dystrophy, procedures which remain in the early stages of clinical trials in the US and Europe.
Figures showing the scale of medical tourism are difficult to verify, but one of Beijing’s most well-known clinics, the Wu Medical Center, claims to have treated 2,800 patients over the past six years, of whom 96 percent were from abroad. China has emerged as the most popular destination for those unable to receive stem cell treatments at home. It is believed to account for 86 percent of the world’s stem cell tourism.
Scientists and doctors whose activities are restricted in the West are also believed to be moving to China “in the hope of carrying out their research and realizing their ambitions,” according to deputy head of the Chinese Hospital Association’s legal department, Zheng Xueqian.
But although few researchers in the West deny the potential of these strands of medicine, the lack of information about their long-term effects have led to regulatory caution. There remains a huge amount of uncertainty about the safety and efficacy of the types of procedures being carried out in China.
Posing as a patient with a spinal chord injury and paralysis, That’s Beijing approached the Hope Hospital in Zhuhai, Guangdong, providing less than 50 words about our condition and symptoms. The local, non-Government-affiliated hospital responded within hours, recommending “rapid treatment” and claiming that stem cells provide the “only chance to cure spinal chord injury.”
For USD26,000 the hospital suggested a three-week inpatient program with a series of eight lumbar, intravenous and intramuscle injections. The correspondence claims that 85 percent of such patients saw a “dramatic reduction in symptoms” in two to three weeks, with the other 15 percent experiencing improvements within two to three months. Collectively, this implies a 100 percent success rate for an unproven and potentially dangerous treatment which is still being tested on animals in the US.
After expressing concerns about the safety of the procedure, That’s Beijing’s fictional patient was assured that there are “absolutely no side effect” (sic). The hospital also assured us that stem cell treatments were “safe for all age and many diseases” and that there would be “no drug reaction [and] no discomfort.” When we questioned therapy's legal status, we were told that delays in global clinical trials were only the result of the US being “entangled in politics and public misunderstanding.”
But caution in the West is largely the result of medical, not political, concerns, argues Keith Pollard, the CEO of Intuition Communications, publisher behind the titles International Medical Travel Journal and Treatment Abroad.
“The treatment is very unlikely to be clinically tested or proven, despite what some clinics may claim,” he explains.
To highlight the risks of unproven and loosely-regulated treatments, Pollard cites the example of a British family that made contact with Treatment Abroad after traveling to a local Beijing clinic with their severely autistic son. They spent over RMB20,000 on a month-long program which saw the 4-year-old receive daily injections for a glucose drip and four spinal injections of stem cells. The therapy had no discernible effect, and because the boy had been taken into a private room for the injections to be administered, his parents remain uncertain as to whether he even received the full treatment. Although the parents were not willing to talk further about their ordeal, Pollard reports them telling him: “We have lost our money, and our child suffered so much.”
The effectiveness of such therapies to treat autism remains in question in Western medical circles. There are, however, a limited number of other well-tested stem cell treatments available in the US and Europe, and bone marrow stem cells have been used against leukemia for over 30 years. But without stringent regulations on new therapies’ administration, there are fears that patients may be at risk. Europe’s largest stem cell clinic, the XCell Center in Germany, which exploited a legal loophole to charge patients for experimental trials, was shut in May 2011 when a baby died after receiving an injection to the brain.
Chinese authorities are not oblivious to the dangers. Far from it. New stricter guidelines emerged amid concerns about patient safety and the proliferation of local, unlicensed clinics using medical trials for commercial gain. In 2012, the Ministry of Health halted unapproved treatments and trials, and stopped accepting new applications for stem cell programs, explains the Chinese Hospital Association’s Zheng Xueqian.
The lab at Beijing Puhua International Hospital that will shortly be helping patients regrow damaged cartilage using stem cells harvested from their own belly fat.
“Before 2012, the whole industry was out of control because of a lack of regulation and supervision,” she says. “Then in 2012, guidelines were released and a crackdown was implemented.
“But although there are now guidelines, it is difficult to monitor which treatments go against regulation. Without a defined law, the line between what can and cannot be done is very vague.”
A debate on whether stem cells qualify as drug therapies or medical technologies has also created uncertainty around which department will be responsible for regulation. The Ministry of Health and the China Food and Drug Administration (CFDA) are jointly preparing more concrete and enforceable laws but Zheng says that it will “definitely take a very long time.” In the meantime, unproven therapies are still openly promoted and carried out by local clinics, many of which are staffed by foreign doctors.
But the existing guidelines differ depending on how the stem cells are sourced. Director at the Beijing Puhua International Hospital, Dr. James Quinlan, has been working with a medical team in South Korea to treat severe joint problems with stem cells harvested from patients’ own belly fat, rather than donor umbilical chords or embryos. He plans to launch the therapy commercially in China this year.
Currently, patients with damaged cartilage in their knees or hips often face complete joint replacements, major surgical procedures that the American doctor describes as “barbaric.” He claims that the new treatment can regrow cartilage and delay, perhaps indefinitely, the need for surgery.
Quinlan’s research places global demand somewhere between heart disease and diabetes. Critical of the “conservative” approach to clinical trials in the West, he believes that China’s medical mindset benefits from its patient-centric pragmatism.
“One of the reasons I came to China was to try and take part in things that make a difference,” he explains. “[China] is the last frontier, the last free country.
“We have a thousand patients who have been [treated] using this technique with a 90 percent success rate. The point is the stuff works. It works without significant complications and it’s predictable and its do-able. We don’t really need to wait for someone else to say that it works to know it works. It’s self evident.
“If I kick a rock my foot will hurt. I don’t need the FDA [Food and Drug Administration in the US] to tell me that. We know from many, many patients that we have a technique that can help hundreds of thousands of people in China, let alone worldwide.
“If you need prospective human data you’re going to be waiting, not until hell freezes over but until it gets pretty chilly, to get information that’s approved and publicly sanctioned for clinical use [in the West],” he says.
A 32-year-old American patient, Albert, who would only give his first name said: “Given my young age [the cartilage] procedure was life changing for me.” He recommended the treatment to other patients in his position, telling us that “there are so many things that can go wrong with a total hip replacement.”
But the moral dilemma of whether patients with serious conditions should have the right to try experimental treatments is less straightforward if they are sold as effective and proven. A number of unlicensed medical centers’ websites across China are littered with unverifiable data on success rates and patient testimonials laden with words like “hope” that arguably exploit those in desperate circumstances.
Investigations by That's Beijing also found that a number of the patients whose stories appear on Chinese medical centers' websites have subsequently died. Although there is no evidence linking their deaths to the treatments, the case studies' continued use highlights the incomplete and misleading information offered to patients. The way that stem cell therapies are promoted skews the ethical debate, according to Intuition’s Keith Pollard.
As well as researching potential uses of stem cell therapy, US-born Dr. Quinlan has ihmself undergone anti-ageing treatment to "rejuvenate and replenish" depleted cell lines.
“The problem is that [stem cell therapies] are not sold to patients as experimental and unproven treatments,” he says. “They are promoted and sold as safe, effective treatments which deliver a miracle cure. The patient is not given the whole truth.”
But one patient who is well versed on the risks and benefits is Dr. Quinlan himself. While in China he has undergone anti-ageing stem cell treatment which he believes may prolong his lifespan through the cells’ ability to “rejuvenate and replenish” the body. He claims that celebrities and leading figures in the Chinese medical community have also undergone the therapy.
“As our cell lines wind down and peter out, so do we,” he explains. “We can repopulate [them with] cells that can look around, adapt, fit in and repopulate with fresh genetic material. I can produce stem cells but they are in their sixties. How nice to have stem cells that are zero.”
Coupled with our growing understanding of how to manipulate human genetics, these advances could ultimately justify Dr. Quinlan’s belief that stem cells represent “one of the most important revolutions in the history of medicine.”
“With stem cells and genetic engineering you will have the possibility of being able to grow new organs. If you’re flexible about how you define life it could be infinite,” he says, although his main concern is having time to complete the 20 years unfinished work that he hopes lies ahead.
Regardless of whether the future of the field lies in immortality or not, it is widely considered to be promising. It is a future that may soon come to be led by China, a possibility that the Government is embracing, according to researcher at the RIKEN Center for Developmental Biology, Doug Sipp.
“The Chinese Government has been interested in expanding innovative sectors of the Chinese economy, including biotechnology,” he says. “For more than a decade now, stem cells have been considered to be one of the hottest fields in biomedical research so China has invested – like many other countries in Europe and elsewhere – in a concentrated fashion.”
While the sums involved may remain modest compared to the US, the Government-affiliated National Natural Science Foundation of China funded 226 stem cell projects between 2009 and 2011 . This number rose to over six hundred in 2012 alone.
The financial gains for Chinese firms could be vast. The global stem cell market is estimated to reach USD120 billion by 2018. But besides economic incentives, state backing for research and development may also be motivated by the public health challenges posed by a large and ageing population. Treatments for conditions affecting the elderly, such as Alzheimer’s disease, have the potential to substantially reduce the imminent burden on Chinese healthcare services. Therapies claiming to help patients produce insulin could also provide a more affordable way to deal with the reported 114 million Chinese people suffering from diabetes.
Differing medical ethics offer China a unique advantage over the West in this regard. Controversy, particularly in the US, is often centered around the creation, and subsequent destruction, of human embryos to harvest stem cells. Religious concerns and the pro-life movement have stalled the progress of many strands of research. But Chinese culture does not bestow moral value on embryos in the same manner. In Confucian thought, life begins with birth, not conception.
This may prove significant. Although not all treatments rely on foetal cells, they are believed to have huge potential due to their ability to take on the behavior of other cell types (unlike many adult stem cells that are limited to the functions of their tissue of origin). China’s comparatively pragmatic attitude toward this moral quandary has seen it escalate its focus in this area of research.There are still regulations on where embryonic cells are sourced, but restrictions are comparatively loose, says Dr. Quinlan.
“You could buy foetel stem cells," he tells us. "There's a lot of material floating around China from legal abortions. If you need to study neural stem cells you can get them.”
The ethical question this poses is just one of many facing China’s biotechnology sector and society at large. Opinion is likely to remain divided over whether the industry represents a dangerous “wild East” or the future home of the most promising developments in the history of modern medicine.