The End

As mentioned in the introduction, our blog’s life span is limited. In fact, it has already come to an end. The EiT course is finished, and therefore also our blog. Through working with the blog we have learned a lot about regulation of stem cell research in different parts of the world. To conclude we have therefore chosen some of our observations, which sum up the situation well.

The articles about current research in the different countries show that research on stem cells and associated technologies can help to treat challenging diseases of the future. Laws and legislations need however to be clarified to avoid misinterpretations and conflicts. Conflicts with the general public and lawmakers are typical problems of today. Vague laws can also prevent results in research, since this will make it more difficult for countries to cooperate. A way of controlling research is by using strict penalties in case of violations or unethical applications of the technology.

The intrinsic value of the fetus has been the major obstacle in religions of the western world, when it comes to embryonic stem cell research. One religious country that has shown great strides is Iran. Iran got a well defined stem cell law, which has made it possible for the technology to thrive. This shows that religion may aid stem cell research, as well as being a major obstacle.

Another important factor is that the public understands what stem cell research is and both its advantages and disadvantages. Decisions made on stem cell research should mirror this majority, and not only influential people in leadership position.

At the end of our project it is evident that money is an important factor for results. Funds should be made available where possible, and not only advance research but encourage it as well. This will lead to a healthy and broad development of this interesting field.

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Comparing stem cell research in the US, Iran, South Africa, South Korea and Norway

In our project we wanted to explore how far certain countries have come in stem cell research. When comparing Iran, Norway, South Africa, South Korea and The United States of America we raised the question: How far has each country come in stem cell research and why have they not gotten further? Is it due to religion, political views, economy or other obstacles?

Religion has for a long time been one of the main obstacles for stem cell research. This has however changed, as common knowledge concerning stem cells has increased. Over 84% of the Norwegian population is a member of the Church of Norway, compared to 76%  Christians in the US. The members of the Norwegian church are however less active. The US is a church-going nation with 40% attending church every Sunday; in Norway only 3% attend church weekly. Both countries also had a strong anti-abortion campaign in the 1970’s, which has been linked to the aversion to stem cell research, but in today’s Norway these are a minority. Federal funds have been stopped in the US, due to a court order arguing that embryonic stem cell research is research executed on cells from an embryo once destroyed, hence violating the Dickey-Wicker Amendment. Governmental backing is minor in Norway as well, and the field is therefore small. The will to invest in the oil industry is huge, which has made stem cell research a field where the government is unlikely to place their money. Although only a small percentage of Norwegians attend church regularly, the Norwegian Christian Democracy Party dominated politics in the early 2000s, and their Christian values have hindered a more liberal stem cell research policy. Lack of funding has led to a slow-down in stem cell research in Norway, while this kind of research has  been driven to the private sector in the US.

A country with strong religious beliefs does not necessarily mean it is an obstacle for stem cell research. Iran, which is a constitutional Islamic republic, is a good example of a country with a strong religion, but where stem cell research flourishes. There are no laws in Islam regulating stem cell research. Instead there are legislations based on opinions stated by an Islamic scholar founded on Islamic law and its interpretation, also called a Fatwa. Ayatollah Khamenei, Iran’s religious leader issued a stem cell fatwa in 2002 stating that experimentation with human embryonic stem cells is consistent with Shiite Islam, thus making stem cell research possible in Iran. Stem cell research therefore got both religious and political backing in Iran, and by this also funding. Muslims believe that life begins after the soul has taken place in the body. This different view of the fetus’s intrinsic value makes it possible for the Islamic faith and research on embryonic stem cells to co-exist. Iran can therefore be seen as quite liberal regarding stem cell research.

When it comes to religion and its impact on stem cell research in South Korea, it is comparable to Norway. Almost half of the population of approximately 49 million is non-religious, the other being mainly Christians and Buddhists. South Korea is a country where biotechnology is an important industry, and stem cell research is set as a government priority and receives large amounts of funds. The pressure of producing results, however, has been huge, something that may have been a contributing factor to the infamous Hwang scandal in 2005. The Hwang scandal was a huge set back, not only for the South Korean biotechnology community, but also across borders. The published results, which were later revealed as fake, gave such big hopes for a revolution in the medical field and treatment of difficult diseases, as well as a basis for a new and very lucrative industry. Although mostly negative, the scandal also had some positive effects on biotechnology research in South Korea. The establishment of the Bioethics and Safety Act set some clear laws and regulations for the research and use, and the field of stem cell research is once again flourishing. Once regarded as a country where stem cell research, especially with embryos, was very liberal, South Korea is now more in line with other western countries with strict laws and regulations.

Stem cells are also a hot topic in South-Africa, with three private stem cell banks storing umbilical cord blood and bone marrow. The stem cells stored can be used by the donor, or others that match, in case of an illness. One major draw-back is that most donations are made by Caucasians, and a match for people of black African descent is therefore difficult to find. The banks also execute research on therapeutic applications of stem cells. South-Africa allows creating human embryos especially for research, as well as therapeutic cloning, and their National Health Act clearly states what is allowed and not. This seems to be an excellent starting point for great development in stem cell research, but due to certain policies it is difficult to do much research.

It seems, that in the last couple of years several countries have softened to the idea of using stem cells for therapy, and new sets of regulations have been made. Policies and religion is tightly linked, but as important is funding, both private and governmental. Norway has the same legislations as other countries, but the lack of governmental backing has led to a slow development. This is also the situation in South-Africa. Governmental backing has led to a development in the field in both Iran and South-Korea, while stem cell researchers in the US heavily rely on private funding. This has given results, since the private sector in the US is both huge and wealthy, and three clinical trials are under way.

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Current Stem cell research in Norway

Researching the possibility to replace injured cartiliage in knees

Research on adult stem cells has been a focus area in Norway since 2002. As a result of new initiative and governmental backing, the Norwegian Center for Stem Cell Research (NCS) was established in 2003. The goal was to bring the stem cell researchers in the Nordic and Baltic areas together through joint research projects. The Research Council of Norway have granted 170 million Norwegian kroner in the 2002-2013 period, however they also finance other stem cell research through other programs. In 2010 six new projects were funded with 3 million Norwegian kroner. One project was to look at stem cells for tissue engineering of bone at the University of Oslo. In 2004/2005 the Norwegian government created a program whose main task was to increase the Norwegian contribution to global knowledge on science. In 2008/2009 the same government also started a new program called climate for research were the main goal was to increase the funds for research and science.

After the ban on embryonic stem cells research was lifted in 2008 the Government wanted to increase the focus on stem cell research. The Research Council of Norway has therefore increased the effort put into stem cell research, both on adult and embryonic stem cells through the program called the stem cell research program 2008-2012. An important part of the program was to establish the National Centre for Stem Cell Research in 2009, and the centre was given 28 million Norwegian kroner over a five year period. The projects started by the centre will be for the welfare of the patients, as well as showing that stem cells can be effective in medicinal treatment. Another aim is to increase the understanding of basic processes tied to growth and differentiating of stem cells from different sources and to bring forth cells or cell lines which can be used in therapeutic approaches.

Norway has a lot of different projects going on when it comes to adult stem cells, as this have been a prioritised field. Norway has taken a big step when it comes to the use of mesenchymal stem cells in cartilage- and bone regeneration. A team of scientists at the University of Oslo has already shown that it is possible to create cartilage cells from stem cells. Although they can grow almost 50 million cartilage cells from about 300 000 stem cells derived from a patient’s bone marrow, it will take 12 to 18 months to grow enough cartilage cells. There are 50 patients in this clinical study and it will take them at least two years to get some answers, but Prof. Lars Engbretsen, the person in charge of this study, is optimistic and believes that the therapy will be standard treatment in a couple of years. At Oslo University Hospital Ullevål there is also a research team focusing on cornea stem cells and other types of stem cells from the eye. Today it is possible to regenerate corneal tissue in patients with unilateral limbal stem cell deficiency. Growth and differentiation of stem cells is also the focus of many research groups in Norway, since this is the second aim of the stem cell research program 2008-2012.

When it comes to embryonic stem cell research Norway is still in the initial phase, since research on embryonic stem cells was banned until 2008. Today, projects concerning embryonic stem cell research in Norway are aiming to make distinct nerve cell types from human embryonic stem cells. One project focuses on creating a nerve cell from stem cells that has a central role in the memory function. The other project focuses on trying to create a nerve cell from stem cells which produce serotin. Serotin is a signalling substance involved in an array of neurological and psychological diseases, like depression, bipolar disease and sleep disorders. There are no clinical trials in Norway yet.

Research on induced pluripotent stem (iPS) cells is also in an initial phase and iPS is therefore at the present used as a tool for studying sickness mechanisms. iPS-cells has been created from skincells in patients with Huntingtons disease, Parkinsons disease, Amyotrophic lateral sclerosis (ALS) and type 1 diabetes. There is not much research in stem cells from umbilical cord blood in Norway. At the moment Norway is considering joining a clinical trial where stem cells from umbilical cord are used in treatment for chronic bone marrow injury, which is an ongoing project between the US and China.

Norway has since 1985 treated blood cancer with bone marrow transplant, an established therapy based on stem cell. In 1989 one started to search for bone marrow donors outside the family and the Norwegians Bone Marrow Registry (NORDONOR) was established. Although NORDONOR have been very successful, when the question about establishing an umbilical cord blood bank in 2005 was raised it was voted against. The arguments against establishing such a bio bank is that stem cells from umbilical cord blood are already available for Norwegians through banks in 36 other countries from Europe, North- and South-America, Asia and Australia. This is, according to the report, enough to cover the need in Norway (find another word). As in South Africa the problem is that there are few suitable donors for a patient with a non-European origin, like African. Another point is that it will not be economically viable for Norway to establish a bio bank with umbilical cord blood. In Norway today there are some private companies, like Cryo-Save and StemCare that offers to freeze down stem cells from umbilical cords. The stem cells are however, saved in banks that reside in Belgium and Denmark.

References:

Brinch, L. (2003). Benmargtransplantasjonens historikk i Norge. Retrieved April 13.\, 2011 from http://kfin.no/benmargsforeningen/nyhet_vis.php?nh_id=12

Cryo-Save. Retrieved Mars 29, 2011 from http://www.cryo-save.com/no/#

Det Konkelige Kunnskapsdepartementet (2005). St.meld. nr. 20 (2004-2005) Vilje til forskning. Retrieved March 21, 2011 from  http://www.regjeringen.no/Rpub/STM/20042005/020/PDFS/STM200420050020000DDDPDFS.pdf

Det Kongelige Kunnskapsdepartementet (2009). St.meld. nr. 30 (2008-2009) Klima for forskning. Retrieved March 21, 2011 from http://www.regjeringen.no/pages/2178785/PDFS/STM200820090030000DDDPDFS.pdf

Norwegian Center for Stem Cell Research. Retrieved April 11, 2011 from http://www.stemcell.no/ncs.htm

Forskningsrådet (2010) Resultatet av søknadsbehandlingen i Program for stamcelleforskning. Retrieved April 11, 2011 from http://www.forskningsradet.no/servlet/Satellite?c=Informasjonstekst&cid=1253959691677&lang=no&pagename=stamceller%2FHovedsidemal

Fugelsnes, E. (2010). Vil reparere skadde knær med stamceller. Retrieved March 29, 2011 from http://www.forskningsradet.no/servlet/Satellite?c=Nyhet&cid=1253954854147&lang=no&pagename=stamceller%2FHovedsidemal

Glover, J.C. (2006). Norwegian expertise in stem cell research. Public Service Review Science & technology 06, 216-217. Retrieved April 8, 2011 from http://edition.pagesuite-professional.co.uk/launch.aspx?referral=other&pnum=&refresh=8Jq1F07w4n0Y&EID=d78d37a4-4556-4a57-9b18-8f168996cf9f&skip=

Helsedirektoratet (2011). Evaluering av bioteknologiloven Status og utvikling på fagområdene som reguleres av loven. Retrieved April 4, 2011 from http://www.helsedirektoratet.no/vp/multimedia/archive/00324/Evaluering_av_biote_324329a.pdf

Oslo universitetssykehus (2009). Nytt stamcellesenter åpnet. Retrieved April 2011, from http://old.oslo-universitetssykehus.no/modules/module_123/proxy.asp?C=1067&I=26587&D=2&mid=

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The Hwang scandal

Woo Suk Hwang is a South Korean researcher who in late 2005 became the centre of one of the largest investigations of scientific fraud known to history, when two of his articles containing ground-breaking results in the field of stem cell research was set under investigation and later revealed as fake. In the first article, published in 2004, it was reported that Hwang’s team had succeeded in deriving a pluripotent embryonic stem cell line from a cloned human blastocyst. In the second article, published in 2005, they described how they had successfully established eleven patient-specific embryonic stem cell lines by somatic nuclear transfer of skin cells, retrieved from eleven different patients with a specific disease or injury, into donated oocytes. The stem cell lines matched the patients DNA and were immunological compatible. In theory this means that the pluripotent stem cells from the established stem cell lines can be transplanted back into the sick or injured patient, where it will differentiate into new tissue, replace the sick or damaged tissue and cure the patient. As the stem cells is derived from the patients’ own cells and are immunological compatible, complications like immune rejection are also less likely to happen.

The results were ground-breaking, as cloning had previously only been done in sheep, mice, cows and other mammals. But the fact that it was possible with these mammals, gave hope to that it eventually could be done with humans as well. Hwang used well-known methods for cloning but with some modifications, which made the concept not too difficult to grasp. What was more surprising was the high success rate of cloning they achieved. Cloning had previously been very inefficient and required a lot of trial and error.
The problems for Hwang and his crew began a few months after the first paper was published, when the methods by which they had obtained egg cells were questioned in an investigation started by the scientific journal Nature. As other researchers around the world had a very limited access to eggs, Hwang’s team allegedly had heaps of eggs at their disposal. Where did they all come from?
Some time after the second paper was published in 2005, more problems arose for Hwang and his crew, as a tip from a former lab-worker of Hwang to a South Korean TV-station raised doubts about the validity of the results from the 2005 paper. Based on the suspicion of ethical breaches regarding the egg harvesting and the tip of a possible faking of results, a team of journalists started to dig deeper – uncovering more and more unpleasant details.

Investigations revealed that the obtainment of eggs had been exposed to clear ethical breaches in that several donors had been paid and that female junior lab-workers had been asked to contribute. The number of eggs used in the research also appeared to be grossly understated. For the 2004 study it was first reported that 242 eggs had been used, while for the 2005 study the number was 185. It was later revealed that the total number for these studies was 2061 eggs, from 129 different women. This was considered an ethical breach because the egg donation involves a treatment where hormones are given to the women to induce superovulation to produce more eggs. Side effects from this treatment can be very unpleasant and is not considered entirely risk free. The fact that payment was offered for the eggs could have contributed to women which normally wouldn’t want to donate, did so because of the offering of money. The participation of junior members of Hwang’s own team can also be considered unethical, as coercion could have been a factor.

When it comes to the question whether the results in the mentioned articles had been fabricated or not, a university committee was appointed to investigate. The conclusion was discouraging.
The cell line from the 2004 paper turned out to be derived from a parthenogenic embryo, where an embryo develops from an unfertilized egg cell, and not from a cloned embryo as claimed. Also in the 2005 paper the results were revealed as fake. The data was based on two cell lines, not eleven, and nor were they patient-specific as claimed.

The disclosures resulted in Hwang resigning from his position and an indicted of three charges: fraud by knowingly using fabricated data, violating the bioethics law and embezzling of research funds to buy eggs. He was not found guilty in fraud, but for the other two he was found guilty and sentenced to two years suspended prison sentence. Hwang admitted to buying eggs and faking data, but maintained that the techniques that were used for cloning are valid.

So why did he do it? There have been many speculations, but Hwang himself have not been very talkative on the issue. One theory is that Hwang was under a lot of pressure. His achievement as a researcher had given him stardom in South Korea – he was a stem cell superstar. But people expected even more. And to deliver ground-breaking results in human cloning and have it published in a top journal would give him status as one of the greatest researchers in history. Another theory say that the Korean culture may have contributed in the way that they are expected to do everything fast. But this was also Hwang’s personal desire. He was extremely hard working, always being the first to arrive and the last to leave the lab.

Hwang and his cloned dog Snuppy

Besides being revealed as a faker and sent home in shame, Hwang has also without a doubt done good things for science as well. Perhaps what he’s second most famous for is the cloning of the Afghan dog Snuppy, which was created by transfer of a nucleus from a somatic cell into an oocyte.

Also, although maybe not on purpose, Hwang was the first one to produce a human embryo from parthenogenesis, when he was actually trying to clone an embryo as described in the 2004 paper. So he wasn’t all bad ☺.

Last, but not least, the scandal in South Korea lead to a series of revisions of the current Bioethics and Safety Act in order to create a clear set of regulations and laws to regulate biomedical research.

References:

Woo Suk Hwang – Nature news, Nature Publishing Group (2006). Downloaded on the 23rd of March 2011 from http://www.nature.com/news/specials/hwang/index.html

Photo:

See Spot get cloned, ZDNet. Downloaded on the 8th of April 2011 from http://www.zdnet.com/photos/photos-see-spot-get-cloned/14772?seq=2

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Word of the week: Embryonic stem cells

These cells can develop into any of the cells found in adult organisms and are formed from the inner cell mass in the blastocyst, about 5 days after fertilization. These are among the most important in stem cell research because they can be changed and developed into specific tissues for therapeutic purposes; to help damaged body parts heal; form new tissue among others.

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Current state of stem cell research and its application in South Africa

Stem cells have currently become a “consumer item” of sorts; and private stem cell banks have been established.  These store tissue and stem cell rich blood which can be used later by donors to treat illnesses. It is therefore like a sort of “insurance policy”. Currently, plans are far underway to establish a public stem cell bank for South Africa. There are however, currently only three stem cell banks in Africa, with all of them concentrated in South Africa. These are private facilities and carry out therapeutic research and application into stem cells.

The first indigenous stem cell bank was established in September 2005 and is known as Lazaron Biotechnologies (SA) Ltd. Lazaron works in close collaboration with the University of Stellenbosch to commercialize the outcome of research carried out in the Department of Animal Sciences in the University. Lazaron specializes in the storage of infant umbilical cord blood storage and preservation for use in later years to treat diseases for which stem cells prove invaluable. According to the Lazaron website, their main focus is to “develop stem cell related biotechnologies” and come out with health enhancing knowledge and products through the compassionate, careful and concerned use of adult stem cells. They specialize in the cryopreservation (freezing to sub-zero temperatures using liquid nitrogen) of stem cells and store these preserved samples in the country for a fee. Parents usually bank the umbilical cord stem cells of their new born infants. Parents have the option of making a lump sum payment, yearly or monthly payments.

Netcells Cyrogenics is another stem cells bank.  It is private and South African owned, with their storage facilities in both South Africa and in the United Kingdom. They specialize in three different types of   cryogenic preservation.

(i)                  Baby stem cell banking: preservation and storage of  cord blood and umbilical cord tissue

(ii)                Adult stem cell banking: preservation and storage of peripheral blood (from blood stream for bone marrow transplants) and fatty tissue stem cells (mesenchymal)

(iii)               Reproductive cell banking: preservation and storage of eggs and sperm for future fertility treatments or artificial insemination purposes

The Netcells laboratory has also successfully processed over 100 peripheral blood stem cell collections for transplants in cases of leukaemia and other specific cancers as well as blood disorders.

Cryo-Save claims to be the oldest stem cell storage service in South Africa but stores its preserved cord blood and cord tissue stem cells at its parent facilities in Belgium. The company claims that it is more advantageous to do this abroad since it actually improves the quality of stem cells because South Africa has the possibility of future restrictive legislation on stems cells research. Netcells and Cryo- Save are accredited by the ISO (International Organization for Standardization) system, but Lazaron is in the process of gaining accreditation.

This is a very interesting claim, since in 2006; a BBC news item reported that a South African based stem cells company, Advanced Cell Therapeutics (ACT) was buying stem cells meant for research purposes from California and then storing them in the United Kingdom by a company known as CryoStore. These cells were then transported to South Africa and injected into patients for therapeutic purposes. This was probably a way of “going around” the restrictive legislation in South Africa concerning the use of stem cells for research or therapeutic purposes. It looks like ACT has been silent in South Africa since then, but a look at their website shows that it is still actively involved in stem cells research and medical biotechnology in the Western world. They are currently making inroads in China where they have been given a broad patent to use human embryonic derived stem cells technology for research and therapeutic purposes.

Currently, Netcare, which is the largest private hospital chain in South Africa and the United Kingdom has the largest stem cell transplant unit, and carries out 80 annual transplants on the average. This has helped treat many adults and children who have serious blood diseases and cancers.

Since South Africa has proven to be very far advanced in stem cells technology,  when it is compared to other African countries. It has become an important medical destination for people suffering from blood and bone marrow disorders as well as certain types of cancers. Ghana, a West African country was in the headlines in 2007 when a massive drive to establish a bone marrow registry was initiated to help find matches for leukaemia sufferers. This was because most of the available stem cells from South Africa were from white and mixed donors, making the finding of a match for a black person very difficult. Ghana however, lacks the logistics to start up a stem cell registry or bank, and so many people with these life threatening diseases inadvertently die or have  seek treatment elsewhere at a great cost to patients. One other big issue with stem cells research is superstition. In most African communities, the umbilical cord must be buried after birth because it is believed that anyone with access to it could exert some spiritual influence on the child. This has led to skepticism towards cord tissue and cord blood storage in most African societies. However with the success of these transplants making the headlines, more and more people are willing to donate adult stem cells to save other peoples’ lives.

The future for stem cell research in Africa is very promising, but the huge amount of investment and capital needed, together with religious beliefs will lead to slow advances in this field of research until the ethical debate can be resolved.

References:

ACT website. Retrieved 29th March, 2011 from: http://www.advancedcell.com/

Cryosave website. Retrieved 29th March, 2011 from: http://www.cryo-save.co.za/why_offshore.htm

Lazaron Biotechnologies (SA) Ltd. Retrieved 29th March, 2011 from:  http://lazaron.co.za.dedi412.your-server.de/news/

Netcells Cyrogenics website.  Retrieved 29th March, 2011 from: http://www.netcells.co.za/

Watts, Susan (2006). Stem cell treatment warning. Retrieved 29th March, 2011 from: http://news.bbc.co.uk/2/hi/programmes/newsnight/5299306.stm

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Word of the week: Therapeutic cloning

Therapeutic cloning is the manipulation of genetic material from either adult, zygotic or embryonic cells in order to alter the functions of cells or tissues for therapeutic purposes.

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