Stem cell research in the US: research

The first stem cell was isolated in 1998 by a research group led by Dr. James Thomson at the University of Wisconsin. The same group also developed a technique for growing the cells. This happened only 13 years ago, which means that stem cell research still is in an early stage. The NIH funded a basic human embryonic stem cell study in 2002. The outcome of this study has been used to begin developing different stem cell-based therapies.

Some research has come as far as clinical trials. As of March 22, 2011 there are three clinical trials registered by the NIH. First out were Geron, a biotechnology company, who are testing the safety of using human embryonic stem cells for restoration of the spinal cord. Special cells derived from human embryonic stem cells will be injected into the patient’s spinal cord, and oligodendroglia will develop from the precursor cells.

Researchers at ACT derive embryonic stem cells by taking a single cell from an embryo (top image). Retinal pigment epithelial cells (bottom image) derived from human embryonic stem cells might slow vision loss in people with macular degeneration.

Another biotechnology company, ACT, got two clinical trials going. The first trial was announced on November 22, 2010, and will use retinal cells derived from human embryonic stem cells to treat Stargardts Macular Dystrophy (SMD). SMD causes vision loss and is the most common form of inherited weak sight. The disease is caused by the death of photoreceptors in the macula, or degeneration of the macula, and therefore decreases the sharp central vision. The other trial ACT got going is set to treat patients with age-related macula degeneration. This is also uses retinal cells derived from human embryonic stem cells. The trial was announced on January 3, 2011, and is therefore the most recent.

Stem cells have however been used in therapy for several decades. When treating blood cancer and other blood diseases, such as anemia and inherited immune system disorders, new blood cells are needed. Blood-forming stem cells (hematopoietic stem cells) are found in the bone marrow, and can give rise to all blood cell types. Another source for blood-forming stem cells is umbilical cord blood, which is also used in treatment.

References:

Stem Cell and Diseases. (2011). Retrieved on March 21, 2011, from http://stemcells.nih.gov/info/health.asp

Highlights of Stem Cell Research. (2011). Retrieved on March 14, 2011, from http://stemcells.nih.gov/research/scilit/highlights/

Horowitz, MM. (2004). Uses and Growth of Hematopoietic Cell Transplantation. In KG. Blume, SJ. Forman, FR. Appelbaum (Eds), Thomas’ Hematopoietic Cell Transplantation. (3rd ed, 9-15). Mass: Blackwell.

Photo:

Singer, E. (2011). Patients Facing Blindness to Test Therapy with Stem Cells. Technology Review – Biomedicine. Retrieved on March 14, 2011, from http://www.technologyreview.com/biomedicine/27040/page1/

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Stem cell research in Norway: Political History and current legislation

The Nordic countries are made up of Norway, Denmark, Sweden, Iceland and Finland and are in the lead of biomedicine. These countries have numerous stem cell research projects in progress. Public support and government funding for science and research has led to a leading position in this field. In contrast to Norway’s Nordic neighbours however, Norway distinguishes itself by having a strict legislation regarding
embryonic stem cell. The debate about embryonic stem cell research has been huge. Through history, Norwegians have been afraid of becoming a “sorting society” which is reflected through a preamble in Norway’s biotechnology. This declares that the purpose of the law is to ensure that the medicinal use of biotechnology is utilized to the benefit of everyone in a society in which there is room for all. On the other side Norway has had a liberal abortion law since the late 1970s that have been under debate ever since. These two opposite forces have created political controversy where stem cell research has been looked at as something extraordinary, and not as a normal branch within medicine.

The first biotechnology-related law in Norway was introduced in 1987, concerning artificial insemination. The law also included a ban on embryonic research as a mean of protecting the fertilized egg and prevents it from only being used for the purpose of research. The Norwegian Parliament passed the first official biotechnology Act in 1994 and this Act was one of the first in the world that regulated the medicinal use of biotechnology. The Parliament upheld the prohibition on embryonic research from 1987. This on the other hand, was not according to the wishes of the Government and the Committee on Social Affairs at the time which suggested a use of embryos for research, although very limited. The Parliament decided that the Act was to be revised after five years, since the development within modern medicine is so rapid that there are small opportunities to foresee which area that would need legislation. The biotechnology law only regulates research on embryonic stem cells, while research on adult stem cells is allowed in Norway. Stem cells from umbilical cord, umbilical cord blood, foetus and induced pluripotent stem (iPS) cells are not regulated by the law.

Dolly the Sheep

After the world breaking news in 1997 about Dolly the sheep being cloned successfully, ban on the reproductive cloning of humans was included in the biotechnology act in 1998; this ban was also extended to therapeutic cloning. Scientists were hoping for a liberalisation of embryonic research when the Labour Party (Ap) came into power in 2000. The Labour Party had indicated that they wanted a softening of the Biotechnology Act. The Health Minister from the previous Government, Dagfinn Høybråten from the Norwegian Christian Democratic Party (KrF), wanted to ban the use of cells and tissue from aborted foetuses to research and treatment before the Labour Party came into office, this was however never implemented. The Labour Party minority government only lasted one year and a coalition government with the Norwegian Christian Democratic Party (KrF) in the lead came to power. As a consequence, the legislation in Norway became even more limited; from 2001 to 2005 Norway had the strictest stem cell legislation in Europe.

The majority of people in the Norwegian Biotechnology Advisory Board, an independent consultative body appointed by the Norwegian government in 2000, wanted to allow research on fertilized eggs and therapeutic cloning. In 2002 the Norwegian Government, with Krf in the leading position, instead proposed an amendment which specified that the ban on stem cell research also should include research on cell lines from fertilized eggs and therapeutic cloning. This amendment was implemented.

The Mehmet-case in 2004 was the final push the politicians to lift the ban on embryonic stem cell research. Mehmet was in 2004 a six year old boy with Talassemi, a common hereditary disease, and he needed stem cells from umbilical cord or a bone marrow transplant from a healthy sibling with a compatible tissue type. No one in his family however, had the same tissue type and the family whished to have a new baby through preimplementation diagnosis that could guarantee that the baby did have the same tissue type, but did not have Thalassemi. A year later it was suggested by an appointed public committee that the Mehmet’s family could go abroad for therapy.

IVF

The Norwegian Parliament wanted the government to propose a revised biotechnology Act which would pave the way for limited research on embryos left over from in vitro fertilization (IVF), and a limited use of preimplementation diagnosis. The Minister of Health and Care at the time, Silvia Brustad (Ap), said that ”the government believes it is important to use the opportunities offered by science to gain knowledge that can be used to treat serious illnesses in the future”, on the proposed legislation. Fourteen years after the first biotechnology Act was passed in 1994, the ban on research on leftover fertilized eggs was lifted on January 1st 2008. Importing embryonic stem cell lines was also made legal. The law states that it is only allowed to use fertilized eggs that have been created in IVF treatment, and does no longer fulfil its purpose. Research on fertilized eggs can not be carried out later than 14 days after the egg has been fertilized. It is also important that it is not allowed to fertilize a human egg solely with the purpose of performing research on it. Left over fertilized eggs can only be utilized in research when the goals are to:

1) to develop and improve new methods and techniques for IVF

2) preimplementation diagnostics

3) attain new knowledge about new treatments against serious illnesses in humans

In a survey carried out by Perduc assigned by the Department of Health showed that there is an agreement in the Norwegian public that stem cell research has a great potential to a positive development. On the other hand stem cell research should be carried out under strict legislation as there are a lot of ethical issues surrounding the subject. At the present, from being on the most conservative countries in Europe in regards to stem cell research, Norway is now more in tune with its neighbouring countries.

References:

Det Kongelige Helsedepartement (2002). Ot.prp. nr. 108 (2001-2002) Om lov om endringar i lov 5. august 1994 nr. 56 om medisinsk bruk av bioteknologi (forbod mot terapeutisk kloning m.m.). Retrieved March 9, 2011 from  http://www.regjeringen.no/Rpub/OTP/20012002/108/PDFA/OTP200120020108000DDDPDFA.pdf

Det Kongelige Helse- og omsorgsdepartementet (2005). Ot.prp. nr. 26 (2006–2007) Om lov om endringer i bioteknologiloven (preimplantasjonsdiagnostikk og forskning på overtallige befruktede egg) Retrieved March 9, 2011 from http://www.regjeringen.no/pages/1929395/PDFS/OTP200620070026000DDDPDFS.pdf

Folge, L.L. (2006). Mehmet-saken – en seier for pressen? Retrieved April 12, 2011 from http://www.bionews.org.uk/page_12970.asphttp://tidsskriftet.no/index.php?seks_id=1357839

Khadija Ibrahim (2007). Norway could lift ban on embryonic stem cell research. Retrieved March 30, 2011 from http://www.bionews.org.uk/page_12970.asp

Lovdata (2011). Lov om humanmedisinsk bruk av bioteknologi m.m. (bioteknologiloven). Retrieved February 24, 2011 from http://www.lovdata.no/all/tl-20031205-100-001.html

Nordforsk (2007). Stem Cell Research in the Nordic Countries  Science, Ethics, Public Debate and Law. Retrieved April 13, 2011 from  http://www.nordforsk.org/_img/nordforsk_pb2_web.pdf

Perduco (2010). Bioteknologiloven Undersøkelse om holdninger til etiske problemstillinger. Retrieved March 30, 2011 from  http://www.helsedirektoratet.no/vp/multimedia/archive/00302/Bioteknologiloven_-_302019a.pdf

Photos:

Imperial Collage London (2007). 1997 – Scientist Clone Sheep. Retrieved May 2, 2011 from http://www.imperial.ac.uk/centenary/timeline/1990.shtml

Mulkas Helsereiser (2009). IVF – Fertility. Retrieved May 5, 2011 from http://www.mulkasgroup.com/health/ivf-fertility/

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Word of the week: Reproductive cloning

Reproductive cloning is the manipulation of genetic material in order to achieve the reproduction of a human being and includes nuclear transfer or embryo splitting for such purpose. The living being is a genetic replica of the source of genetic material.

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Ethical issues in South Africa

By virtue of South Africa having a Christian majority, several issues have been raised in the courts against embryonic stem cell research. According to South African common law however, a legal personality is one who has been born and is completely separated from its mother and must have been alive, even if for just a short period. These arguments possibly influence the law which bans reproductive cloning. According to the South African constitution, everyone has the right to bodily and psychological integrity, which includes the right to make decisions regarding reproduction. The constitution also states that every person has the right to life. The law does not however fully describe what constitutes a person. It also does not refer directly to embryos or fetuses or even define these terms.

This had led to a moral dilemma where the Christian majority believes that the embryo is a living entity and therefore has a right to life. From a Christian point of view, embryonic stem cell research is distasteful as it involves the sacrificing of an embryo which could have developed into a baby. The belief that the embryo is a living thing from conception has also led to the argument that it has a right to life.

There have been debates on when life begins with some saying it begins with conception and others 24 hours after, to mention some of the standpoints. In 1998, the Christian lawyers association also strongly opposed embryonic stem cell research using the arguments above about the constitutional rights of “everyone”.  They also protested against the legalization of abortion using the same arguments. This became a court case where they sued the Minister of Health. The case was however dismissed due to a procedural ruling.

Tug of cells

References:

Republic of South Africa (2003). National Health Bill (B 32B-2003). Retrieved March 9, 2011 from http://www.doh.gov.za/docs/bills/b32b.pdf

Republic of South Africa (2004). National Health Act No. 61, 2003 in: Government Gazette No. 26595. Retrieved March 9, 2011 from: http://www.doh.gov.za/docs/legislation-f.html

International Consortium of Stem Cell Networks (2008).  Global regulation of human embryonic stem cell research and oocyte donation. Retrieved March 9, 2011 from: http://icscn.files.wordpress.com/2008/09/global-regulation-hesc-research-oocyte-donation-sep-08.pdf

Swanepoel, Magdaleen (2006). Embryonic stem cell research and cloning: A proposed legislative framework in context of legal status and personhood. Magistic Legum dissertation submitted to the Faculty of Law, University of Pretoria. Retrieved March 9, 2011 from: http://upetd.up.ac.za/thesis/available/etd-07312007-150150/unrestricted/00dissertation.pdf

Roppen, H.J  & Bishop, A.E (2004). Embryonic stem cells. In Cell Proliferation Vol 37, 1

Statistics South Africa  (2003). Census 2001. Census in brief (PDF). Rep. 03.02.03 (2001) Retrieved March 9, 2011 from: http://www.statssa.gov.za/census01/html/CInBrief/CIB2001.pdf

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Word of the week: Cell line

A cell line is a group of constantly dividing cells. They are obtained from human or animal tissue and can replicate in vitro for a long period of time. One of the more common cell lines is HeLa, which was obtained from Henrietta Lacks, who died of cervical cancer in 1951.

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Stem cell research in the US: religious views

The main reason for the US’s opposition to stem cell research is based on their culture. Immigration has been the major source of population growth since the 16th century, when Europeans immigrated to the US in search of a better life. Later on, immigrants from other continents started arriving, leading to a mixture in both cultural background and religion. However, the majority are Christians (76%), where 51% identify themselves as Protestants and 25% as Catholics. Non-Christian religions, like Judaism, Islam, Hinduism and Buddhism, make up 3.9% to 5.5 % of the adult population. These figures are taken from the Pew Forum on Religion & Public Life. Protestantism, Catholicism, Judaism and Islam will be discussed further in this article.

Compared to other countries the USA is a religiously active nation, where people often attend religious services. A research showed that 40% of the population attended religious services weekly, compared to the UK where only 5% where in church on a weekly basis. The survey also took scientists in the genetic field into account, and 36% of these attended services at least once a month. This research shows how important religion is in the US, and also explains the anti-abortion movements’ position in the country.

The main topics in the ethical debate are:

  1. Does the fetus have intrinsic value in whatever development stage it is in, and wherever it is (in womb or dish)?
  2. Can stem cell research be separated from the abortion debate?

There are of course other questions as well, but the political debate has focused on these so far. They are also more interesting from a religious perspective, since they vary a lot. The National Conference of Catholic Bishops is one of the most vocal participants in the debate. These are however, very conservative, and do not represent all Catholics. A worldwide survey conducted by the Boston Globe even suggests that 63% of people with a Catholic belief approve of stem cell research and funding. Roman Catholic doctrine says that embryos have an intrinsic value. This led the Pope to publicly express his disapproval of this kind of research after President Bush’s speech to the nation on stem cell research and funding. The Popes disapproval was not made public ex cathedra, which would have made it Gods word, and therefore become Catholics belief. This view have started to mellow, and some theologians evens suggests that human embryos less than 14 days old cannot be considered as individualized human entities. At approximately 14 days the primitive streak is formed, which marks the point when the clump of cells turn into embryo and placenta. This is based on Old Catholic tradition, where the soul is not embodied early in the development. Protestants in the US have, on the other hand, always supported science. This is based on the belief that the world God created is faulty, and that humans and God have to cooperate to create a better world. Denominations like the Presbyterian Church and United Church of Christ support stem cell research based on this, while more conservative groups, like Missouri Synod Lutheran Church and United Methodist Church believe in the intrinsic value of the fetus. In Jewish law there is a difference between a fetus in the body and outside, and for the first 40 days the fetus is described as “water” in Jewish tradition. This makes it easier for people of Jewish origin to accept stem cell research, since such research can treat disease and give access to treatment.  Muslims also have a more liberal view and mean that the fetus becomes an individual 120 days (see post on stem cell research in Iran) into the pregnancy, but this has been discussed in an earlier blog post.

These cultures have very different beliefs, and a compromise between them in the future is highly unlikely. Several attempts on legalizing both research and funding have been made, but have always been stopped. The main argument from the Conservatives has been that this will encourage murder. Bush made a fair attempt in 2001, by suggesting that federal funding should only be permitted on stem cells that had been derived before the date of his speech. From the Bush administrations point of view, this would not encourage murder. This statement was illogical from a scientific point of view, and was rather a political attempt of calming conservatives and scientists.

On March 9 2009 Barack Obama overturned Bush’s ruling, which led to several conservative groups expressing their dissatisfaction. Among them was The National Conference of Catholic Bishops. People still feel very strongly about this case, and would rather use adult/pluripotent stem cells for research than embryonic. There is however not much they can do, since they are not in any strong political position.

References:

Wertz, DC. (2002) Embryo and stem cell research in the United States: history and politics. Gene Therapy 9, pp. 674-678.

Wertz, DC. (2002) Embryo and stem cell research in the USA: a political history. TRENDS in the Molecular Medicine, Vol. 9 No. 3, pp. 143-146.

Pew Forum on Religion & Public Life. (2007) U.S. Religious Landscape Survey. Retrieved on March 14, 2011, from http://religions.pewforum.org/pdf/affiliations-all-traditions.pdf.

Secretariat of Pro-Life Activities. (2009) Points to consider: The New NIH Guidelines for embryonic stem cell research. The National Conference of Catholic Bishops.

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Stem cell legislation in South Africa

South Africa is by far the most developed African country, and owes much of its ‘modernity’ and industrialization to the early influx of external European influences. Contributions from indigenous African tribes and migrants from Asia have also played an important part. This melting pot of cultures has led to making it very diverse and open to technological advancement.

The first human heart-to heart transplant was carried out in 1967.  Stem cell research in Africa is really prominent in South Africa. There are stem cell banks which “store” cells of clients for future use. It is the only country in Africa so far with significant advances into stem cell research and its applications. South Africa has adopted the “intermediate approach” to stem cell research and use, where research is allowed, but has some level of restriction by the government. 79.9% of the population professed to be Christians in the 2001 national census. This huge majority largely skews parliamentary debates on controversial medical issues. South Africa is a parliamentary republic and legislations are subjected to strict parliamentary debate.

In the area of stem cell research, South Africa allows the derivation of human embryonic stem cells from excess In vitro fertilization (IVF) embryos, and also allows for the creation of human embryos for research. Speaking generally, South Africa has a ban on reproductive cloning, but not for therapeutic cloning. Stem cell facilities found serve therapeutic purposes, and all research involving human participants must be reviewed by ethics committees. The Human Tissue Act, which was amended in 1985, was the first kind of legislation concerning stem cell research or use. It makes provision for the use of tissues and gametes which are removed from living donors for medical purposes. This act also prohibited the use of the placentas’ fetal tissue for medical purposes. The prohibition took into account transplantation, therapeutic, diagnostic or prophylactic substances. Exceptions can be made with consent of the Minister or his nominee. The law also prohibited the genetic manipulation of gametes or zygotes outside the human body.

In 2003, the Ministry of Health passed a law which became known as the National Health Act. This law specifically spelt out the regulations which were to regulate stem cell research and utilization in South Africa.  Several sections of the health act state whether tissues from dead persons can be used, at which age embryos can be obtained, and where to obtain permission.

The National Health Act (Act No. 61, 2003) stipulates  that a person may not remove tissue, blood, a blood product or gametes from the body of a another living person.  Section 56 states that it can be done with the written consent of the donor, and if it is done in the prescribed manner and conditions.

Such samples should not be taken from a mentally ill patients or patients whose tissues may not be replaceable by natural processes. It further states that placenta, embryonic or fetal tissue, stem cell or umbilical cord may not be used. An exception is made with stem cells derived from umbilical cord progenitor cells. Progenitor cells have limited differentiation and are highly specialized.

On reproductive cloning, the act prohibits the manipulation of genetic material (including human gametes, zygotes or embryos), or things like nuclear transfer or embryo splitting for the purpose of the reproductive cloning of a human being. The Minister however, has the right to permit therapeutic cloning using utilizing adult or umbilical cord stem cells.  This therapeutic research is permitted on stem cells and zygotes less than 14 days old, if written consent is obtained from the donor. Offenders face up stiff fines and a jail term of up to five years if the law is violated.

References:

Republic of South Africa (2003). National Health Bill (B 32B-2003). Retrieved March 9, 2011 from http://www.doh.gov.za/docs/bills/b32b.pdf

Republic of South Africa (2004). National Health Act No. 61, 2003 in: Government Gazette No. 26595. Retrieved March 9, 2011 from: http://www.doh.gov.za/docs/legislation-f.html

International Consortium of Stem Cell Networks (2008).  Global regulation of human embryonic stem cell research and oocyte donation. Retrieved March 9, 2011 from: http://icscn.files.wordpress.com/2008/09/global-regulation-hesc-research-oocyte-donation-sep-08.pdf

Swanepoel, Magdaleen (2006). Embryonic stem cell research and cloning: A proposed legislative framework in context of legal status and personhood. Magistic Legum dissertation submitted to the Faculty of Law, University of Pretoria. Retrieved March 9, 2011 from: http://upetd.up.ac.za/thesis/available/etd-07312007-150150/unrestricted/00dissertation.pdf

Roppen, H.J  & Bishop, A.E (2004). Embryonic stem cells. In Cell Proliferation Vol 37, 1

Statistics South Africa  (2003). Census 2001. Census in brief (PDF). Rep. 03.02.03 (2001) Retrieved March 9, 2011 from: http://www.statssa.gov.za/census01/html/CInBrief/CIB2001.pdf

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