Stem Cells, and more specifically, stem cell therapies, are a field of medicine which over recent years has become more and more controversial. As more people become involved in the topic, whether it be through simple education, research, or medical operation, there beings to amass a growing voice for the many issues, and benefits, of this undoubtable medical marvel. The controversy is fueled by many factors, those being of ethics, power, money, and safety – and when considering the situation in Australia, there are many questions surrounding stem cell therapies, which are left unanswered. However in a field such as stem cells, there may never be one best answer. A technology that has the estimated potential of stem cells attracts the interest of many different stakeholders, all of which aim to benefit off of this treatment, and all of which have their different reasons and arguments for doing so.
Stem cells, by definition, are unspecialized body cells, with the ability to replicate themselves and also differentiate into another specialized cell when called upon. There are two main types of stem cells: Embryonic, and Somatic, and each cell as a select level of the property “potency”. Potency, in the context of stem cells, refers to the range of body cells a stem cell can differentiate into. The most powerful being pluripotent cells, which can differ into any type of body cell, and the next being multipotent cells, which can only differ into cells which relate to where they originated from. Embryonic cells are derived from the blastocyst of an embryo, and have the property of being pluripotent, while also being able to be cultured for a very long time under the right conditions – and are at of less risk to immune rejection then somatic cells. However, despite their outstanding advantages, there are certain ethical and safety concerns involving their research and implementation. The most obvious being where the cells come from – embryos, which are terminated during the process of extracting the cells. For some people who consider an embryo to be a living being, extracting embryonic stem cells from them is considered highly immoral and therefore unacceptable. In fact, in many countries, stem cell research using the human embryo is illegal in Germany, Austria, Ireland, Italy, and Portugal. Like embryonic cells, somatic cells also have their advantages and disadvantages. Somatic cells are multipotent, which means the only cells which they can specialize into, are those related to where they originate from. For example: a common somatic transplant used in the treatment of cancers and other illnesses, is that of bone marrow. The stem cells inside this marrow are multipotent though, and therefore the only cell types they can differ into are blood and immune related. However, while they may be harder to use, somatic cells are much more ethically approved. They do not require the termination of an embryo, and are instead derived from developed humans – also meaning that many more cells can be collected in a single dose, without the need to wait for allowing time to culture.
Also apart of the controversy, are so called Autologous stem cells, and their related therapies. These cells are simply somatic cells, but when used in cell therapy, they are extracted from the patients own body. This adds on another advantage for somatic cells, as transplanting one’s own biological material greatly reduces the risk of immune rejection, which if it is to occur, can lead to many more issues. One such example of an autologous stem cell therapy, is that of Lipoaspirate Prolotherapy – which is the treatment of chronic musculoskeletal conditions, such as the degradation of the bodies joints, by stimulating tissue repair in the target area – through the injection of autologous stem cells, which have been derived from the bodies own fat cells via liposuction.
Despite the promising potential of stem cells and their therapies, there are many countries which are against their research and implementation – but also countries, like Australia, which have left stem cells in a grey area in terms of their regulation. When considering Autologous stem cell therapies, most of which are still experimental, are exempt from the many regulations surrounding trial protocol – simply because they are autologous transplants. So while this exemption surrounding protocol allows for a much easier research process, it also allows for the mishandle, or bad practice of science, to find its way into stem cell research. This begs the question: Should Australian doctors be allowed to sell unproven stem cell treatments using the patient’s own cells (so called autologous ‘stem cell’ therapies) or should regulations be tightened to protect patients from physical and financial harm? This question can be handled in many different ways as per the different views of the stakeholders involved, and by the ethical/safety factors which surround it. The biggest, and to some: the only problem, is that the treatments are unproven. This means there is still not enough evidence from clinical trials which warrants these treatments as working and safe. Therefore, the view can be taken, that doctors who sell these treatments, are taking advantage of their clients money because the chance of succession is not properly documented and proven, or requires more evidence. DR DONALD KUAH, SYDNEY SPORTS MEDICINE CENTRE – when interviewed on SBS about Autologous stem cell therapies in Australia, gave insight into one of his preclinical trials, that was published in August 2012 looking at the secretions of the stem cells. Of the 30 people in the trial “about 75 percent of patients say they get pain relief at six and twelve months.” He concludes by stating: “I think in terms of osteoarthritis the evidence is still equivocal. Some studies find benefits, some do not. This is why we need to do these carefully controlled trials where we observe the patients very carefully over a long period of time to really get an idea whether the treatment is safe and effective.”
This question can also be looked at from the perspective of a corporation or business, which may be involved in the manufacture of stem cells. Certain businesses, if given the chance, may undoubtedly take advantage of stem cells and their benefits. When research is complete, and trials bear positive results, mass manufacturing can commence for the “miracle treatment,” taking advantage of the potential for high demand and low supply. If money is involved, it seems right to be skeptical and assume dirty play. There is always the possibility that companies looking to gain a push-up in the race, could use their money and/or influence to help support people who push for the success of stem cell therapy, so mass production can begin. A 2010 published article – “Tracking the rise of stem cell tourism” – which aimed to sought to categories and characterize the individuals who traveled overseas for unproven therapies, began to take data from the many blogs written by these patients. One such conclusion from the data, yielded the concern that “ the prominence of blogs associated with one Chinese company, Beike Biotechnology.” Beike, a provider of stem cells to several different clinics in China, encourages its patients to blog, and it was found that “patients who traveled to one of the several clinics affiliated with Beike Biotechnology accounted for 115 (71%) of the blogs we identified.” This information, raised concerns that “the site manager may choose to list or highlight blogs presenting favorable outcomes.”
Another question to be asked, is that of: If we tighten Australian regulations would that mean that more patients will be forced to travel overseas? Like the previous question, there are many ways in which all different stakeholders can approach this question. From the very start, the simple stance can be taken by people in charge of the policy, that a shift in Australian regulation will not force anyone to go anywhere or do anything. They can still seek treatment, but will simply find it a more difficult and/or rigorous process. This question, once again, is surrounded by ethical and safety. A stance could be taken from the Governments point of view. Supposedly, they want what is best for the people to whom they have been elected in by, but as previously mentioned, when money is involved, views begin to change. Governments could be for the restrictiveness of stem cell therapies, and this would help prevent the many unregulated treatments going on in Australia right now, some of which take advantage of their clients, but also slow the progress of legitimate research. At the same time, Governments could push for a lesser grip on treatments. With more room to work, research could happen faster, then the drug may be proven, and if so, governments, like some large corporations, could take advantage of the massive demand surge, and begin making money off taxes and/or regulating sales. For many Australians however, the current regulations surrounding stem cell therapies, are already too much to handle, and many have gone overseas to get their treatments. This has returned both positive, and negative news. One such case of positive overseas results, is that of patient Kristy Cruise, who traveled to Russia for an autologous stem cell treatment, to halt her Multiple Sclerosis. She did not have the procedure in Australia, as she was deemed to not be in need of the treatment, as she was still showing signs of health, and mild onset of MS, not heavy. After a few weeks of returning from Russia after a successful transplant, Kristy was restored to near full health – exercising and going about her day as if she never suffered from MS. However, one successful case of overseas therapy cannot support the negative cases of overseas therapy, who have left some Australian patients in a worse condition then when they started. One such patient is Annie Levrington, who was diagnosed with MS in 2007. Desperate to do something to halt the progression of the illness, Annie took to the internet. She discovered the XCell-Centre in Cologne, Germany, which treated patients with their own stem cells. However, from the very start, Annie recalls feeling uncertain about her procedure that took place in Germany. After handing over $15,000, she was told that her stem cells has been transplanted to the target area, and that she would feel the positive effects “within the next three weeks to a year.” However after consulting with both a neurologist and a hematologist, there was no evidence that she had undergone a transplantation of any sort. When interviewed about the matter on ABC, Megan Munsie from Stem Cells Australia comments “I think we have to be very aware of Dr Google and I also think we have to be aware of patient testimonials.” In another incident, Brisbane mother Kelly van Meurs died of a heart attack while receiving stem cell treatment in Moscow for her rare neurological disorder, Stiff Person Syndrome. Munsie says that “The concern is we don't really know. We're not learning from it. People are prepared to put themselves at risk to participate in these experimental treatments, but we're not finding out any answers, we're not learning from it.” However, despite all this, it must be made clear that Governments are not supposed to be forcing anyone into any decision. Whether it is ethical or not, there may always be another option then Stem Cells – and in addition the previously referenced, “Tracking the rise of stem cell tourism” article, also found that “many patients were aware of skepticism of these treatments by physicians in their home country and chose to pursue these unproven treatments despite warnings about potential health risks and concerns about limited efficacy.”