StemCell Therapy

"Ethical Issues in Human Stem Cell Research: Executive Summary" was published in September 1999 by The US National Bioethics Advisory Commission in response to a national debate about whether or not the US federal government should fund embryonic stem cell research. "Ethical Issues in Human Stem Cell Research" recommended policy to US President William Clinton's administration, which advocated for federal spending on the use of stem research on stem cells that came from embryos left over from in vitro fertilization (IVF) fertility treatments. Although NBAC's proposals never became legislation, the report helped shape public, private, and international discourse on stem cell research policy.

The National Bioethics Advisory Commission (NBAC) was initially created by President William Clinton on 3 October 1995 and was chaired by Harold T. Shapiro, former president of Princeton University and the University of Michigan. The committee aimed to deliberate on bioethical issues that arose from research on human biology and behavior, during a period of national debate surrounding stem cell research. The committee included members with backgrounds in law, medicine, philosophy, ethics, theology, and psychology.

As the NBAC compiled its report from November 1998 to September 1999, two US laws regulated federal funding of human embryonic stem cell research. First, the 1993 National Institutes of Health Revitalization Act gave the National Institute of Health (NIH) authority to fund human embryo research. Second, the 1995 Dickey-Wicker Amendment banned the use of federal funds for research that created embryos solely for research purposes or research in which human embryos are destroyed. Both of these policies helped cause debate in November 1998 after at least three publications described new possibilities of stem cell research and related ethical quandaries. Within one week, two independent research teams, James Thomson and colleagues at the University of Wisconsin, in Madison, Wisconsin, and John Gearhart and his colleagues at The Johns Hopkins University School of Medicine, in Baltimore, Maryland, stated that they had isolated and cultivated human embryonic stem cells. Furthermore, the New York Times announced that the biotech company Advanced Cell Technology of Worcester, Massachusetts, developed a human-cow hybrid cell by removing the nucleus of the cow egg, and replacing it with the nucleus of a human cell. President Clinton called upon NBAC to evaluate the recently published research on stem cell derivation and somatic cell nuclear transfer. He gave the commission nine months to deliberate, consult experts, balance ethical claims, and formulate policy recommendations, which were ultimately presented in the report published in September 1999.

"Ethical Issues in Human Stem Cell Research: Executive Summary" is organized into an introduction, thirteen recommendations, and a conclusion. In the introduction, NBAC distinguishes embryonic stem (ES) cells for other stem cells as capable of developing into nearly any cell type, whereas adult stem cells have more specific fates, such as renewing tissue in the lining of the gut, revitalizing skin cells and producing a range of blood cells. NBAC then describes the various methods with which researchers derive stem cells, and it lists applications of stem cells for treating disorders.

The report distinguishes between two types of embryos. The first type includes embryos created solely for research purposes though IVF using somatic cell nuclear transfer, a process by which researchers remove the nucleus from a reproductive cell and then transfer the nucleus from a non-reproductive cell into the enucleated egg cell. The second type includes embryos that are initially created for infertility treatment using IVF. NBAC says that adult stem cells are not a legitimate alternative to ES cells because adult stem cells lack the potential to develop into as many cells as ES cells.

The second section of the executive summary presents NBAC's stance as to whether each category of ES cells should be federally funded. The commission asserts that the federal government should fund research using stem cells derived from embryos remaining after IFV infertility treatments. However, they argue that the federal government should not fund research using ESCs when the embryo is created for research purposes by either in vitro fertilization or somatic cell nuclear transfer. These recommendations conflicted with the Dickey-Wicker Amendment, which since 1995 had banned funding that supported the derivation of ES cells. NBAC said that, as leftover embryos from IVF existed, there was no reason to fund scientists to create new embryos for research.

In the third section of the executive summary, NBAC advised private research organizations to employ consistent and ethical standards in its research. They recommended that any federally funded research proposals should be reviewed by the National Stem Cell Oversight and Review panel, to ensure that there is adequate justification for the use of the cell lines. This review panel would require that embryo donors give informed consent for their donation, and it would advocate that the US government create laws that prevent the buying or selling of embryos. In the executive summary, NBAC says that whether the federal government funds embryonic stem cell research or not, or if it decides to fund only certain types of research, privately funded research is exempt from the guidelines of federally funded research. The private sector could not be held to the same standards by the US government, as their funding was not federal. Instead, the private sector would have to voluntarily comply with the requirements that federally funded researchers are obligated to, but with no guarantee that they would do so.

On 14 July 1999 the White House released a statement rejecting NBAC's preliminary recommendations. This was not the first time Clinton rejected the recommendations from his advisory commission. In 1994 Clinton had banned the use of federal funds for embryos created for the sole purpose of researcha few hours after the National Insitutue of Health's Human Embryo Research Panel published their conclusions advising otherwise.

In January 2000, President George Bush took office. July 2001, Shapiro, former chair of NBAC, wrote President Bush to offer NBAC's assistance and to notify him of NBAC's "Ethical Issues in Human Stem Cell Research" report. One month later in President George W. Bush's Announcement on Stem Cells, he revealed that the federal government would only fund embryonic stem cell research from already-existing stem cell lines, and it would not allow funding for the derivation of any new stem cells, regardless of NBACs recommendations. This law was federal policy until President Barack Obama lifted the ban by signing Executive Order 13505 on 9 March 2009, returning to legislation similar to the Clinton administration guidelines from August 2000.

Since its publication, "Ethical Issues in Human Stem Cell Research" was cited by numerous scientific organizations in the US and internationally. In June 1999 UK's Chief Medical Officer, Liam Donaldson, established an Expert Group to give advice on what areas of embryonic stem cell research should receive funding. The group's report, "Stem cell research: Medical progress with responsibility," published a year later, cited NBAC's report as a comparative model. In 2000 the UK's Nuffield Council on Bioethics based their guidelines on restrictions proposed by NBAC regarding the buying and selling of human embryos. When the Canadian Institutes of Health Research deliberated about stem cell research from 1999 to 2000, they also reference NBAC's stem cell recommendations. During this same time, other countries such as Japan and Singapore studied the proceedings and conclusions of the US's National Bioethics Advisory Committee while formulating their own positions on various biomedical topics.

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QUESTION: What is the history of stem cell research?

ANSWER:

The history of stem cell research had a benign, embryonic beginning in the mid 1800's with the discovery that some cells could generate other cells. Now stem cell research is embroiled in a controversy over the use of human embryonic stem cells for research. In the early 1900's the first real stem cells were discovered when it was found that some cells generate blood cells.

The history of stem cell research includes work with both animal and human stem cells. Stem cells can be classified into three broad categories, based on their ability to differentiate. Totipotent stem cells are found only in early embryos. Each cell can form a complete organism (e.g., identical twins). Pluripotent stem cells exist in the undifferentiated inner cell mass of the blastocyst and can form any of the over 200 different cell types found in the body. Multipotent stem cells are derived from fetal tissue, cord blood, and adult stem cells. Although their ability to differentiate is more limited than pluripotent stem cells, they already have a track record of success in cell-based therapies.

A prominent application of stem cell research has been bone marrow transplants using adult stem cells. In the early 1900's physicians administered bone marrow by mouth to patients with anemia and leukemia. Although such therapy was unsuccessful, laboratory experiments eventually demonstrated that mice with defective marrow could be restored to health with infusions into the blood stream of marrow taken from other mice. This caused physicians to speculate whether it was feasible to transplant bone marrow from one human to another (allogeneic transplant). Among early attempts to do this were several transplants carried out in France following a radiation accident in the late 1950's. Performing marrow transplants in humans was not attempted on a larger scale until a French medical researcher made a critical medical discovery about the human immune system. In 1958 Jean Dausset identified the first of many human histocompatibility antigens. These proteins, found on the surface of most cells in the body, are called human leukocyte antigens, or HLA antigens. These HLA antigens give the body's immune system the ability to determine what belongs in the body and what does not belong. Whenever the body does not recognize the series of antigens on the cell walls, it creates antibodies and other substances to destroy the cell.

A bone marrow transplant between identical twins guarantees complete HLA compatibility between donor and recipient. These were the first kinds of transplants in humans. It was not until the 1960's that physicians knew enough about HLA compatibility to perform transplants between siblings who were not identical twins. In 1973 a team of physicians performed the first unrelated bone marrow transplant. It required 7 transplants to be successful. In 1984 Congress passed the National Organ Transplant Act, which among other things, included language to evaluate unrelated marrow transplantation and the feasibility of establishing a national donor registry. This led ultimately to National Marrow Donor Program (NDWP) a separate non-profit organization that took over the administration of the database needed for donors in 1990. The 1990's saw rapid expansion and success of the bone marrow program with more than 16,000 transplants to date for the treatment of immunodeficiencies and leukemia. Adult stem cells also have shown great promise in other areas. These cells have shown the potential to form many different kinds of cell types and tissues, including functional hepatocyte-like (liver) cells. Such cells might be useful in repairing organs ravaged by diseases.

In 1998, James Thompson (University of Wisconsin - Madison) isolated cells from the inner cell mass of early embryos, and developed the first embryonic stem cell lines. In the same year, John Gearhart (Johns Hopkins University) derived germ cells from cells in fetal gonadal tissue (primordial germ cells). Pluripotent stem cell "lines" were developed from both sources. The blastocysts used for human stem cell research typically come from in vitro fertilization (IVF) procedures. The ethical concerns over this type of embryonic stem cell research has been expressed in the following US legal regulations:

In 1973 a moratorium was placed on government funding for human embryo research. In 1988 a NIH panel voted 19 to 2 in favor of government funding. In 1990, Congress voted to override the moratorium on government funding of embryonic stem cell research, which was vetoed by President George Bush. President Clinton lifted the ban, but changed his mind the following year after public outcry. Congress banned federal funding in 1995. In 1998 DHHS Secretary Sullivan extended the moratorium. In 2000, President Bill Clinton allowed funding of research on cells derived from aborted human fetuses, but not from embryonic cells. On August 9, 2001, President George W. Bush announced his decision to allow Federal funding of research only on existing human embryonic stem cell lines created prior to his announcement. His concern was to not foster the continued destruction of living human embryos. In 2004, both houses of Congress have asked President George W. Bush to review his policy on embryonic stem cell research. President George W. Bush released a statement reiterating his moral qualms about creating human embryos to destroy them, and refused to reverse the federal policy banning government funding of ESC research (other than for ESC lines established before the funding ban).

In the November 2004 election, California had a Stem Cell Research Funding authorization initiative on the ballot that won by a 60% to 40% margin. It established the "California Institute for Regenerative Medicine" to regulate stem cell research and research facilities. It authorizes issuance of general obligation bonds to finance institute activities up to $3 billion dollars subject to an annual limit of $350 million.

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History of Stem Cell Research - Popular Issues

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*New 18 June 2012*: The EU ban on embryonic stem cell patents is legally flawed, argues a paper and public lecture by Aurora Plomer, Chair of Law and Bioethics at the University of Sheffield, UK. Find out more.

June 2011: Lately there have been several cases on the patentability of inventions related to human embryonic stem cells (hESC) in Europe. Now the first case has reached the European Court of Justice (ECJ), the highest European court, whose decision will be binding for all EU member states.

The judgement of the ECJ is still outstanding. However, the Advocate General Yves Bot offered his opinion on the case, which points towards a complete prohibition of patents for inventions relating to hESC. While the court does not have to follow the opinion, it does so in a majority of the cases.

The case history The current case arose in Germany from a patent of belonging to Prof. Oliver Brstle. The patent covers neural progenitor cells (precursors of nerve cells), neuronal cells derived from these progenitors, and a method for producing them from hESC lines. hESC lines are typically derived from surplus fertilized egg cells, which are produced in large numbers during in vitro fertilization (IVF) and otherwise discarded. Once established, hESC lines can be permanently maintained and proliferated and thus serve as a source of tissue-specific cells, such as neuronal precursors.

Brstles patent was originally filed in 1997 and granted by the German Patent Office in 1999. In 2004 Greenpeace filed a nullity action against the patent based on reasons of ordre public and morality. A decision of the German Federal Patent Court in 2006 rendered the patent partially invalid, eliminating all claims relating to cells derived from hESC lines. Following Brstles appeal against this decision, the German Federal Court of Justice referred the dispute to the ECJ, arguing that its decision in the case depends on the interpretation of Article 6 of the European Biopatent Directive (Art. 6).

The legal situation The EU Biopatent Directive (Directive on the Legal Protection of Biotechnological Inventions 98/44/EC) was meant to assure harmonized patent protection for biotechnological inventions in the EU. The directive also contains exemptions from patentability including Art. 6(1), which states that patents contrary to ordre public and morality are excluded from patentability. To provide national courts and patent offices with guidance on how to interpret this clause, an illustrative list of examples was incorporated in Art. 6(2) of the Biopatent Directive.

One of these examples has now proven to be key for the patentability of stem-cell-based inventions: Art. 6 (2) (c), which states that in particular uses of human embryos for industrial or commercial purposes shall be excluded from patentability. However, there is no definition of any of the terms used in this provision found within the Directive, neither of the term human embryo nor of what is to be understood by uses for industrial or commercial purposes.

Consequently and contrary to the aim of the European legislator to achieve harmonisation, there are significant differences in how the Directive has been implemented in the EU member states, and even more variation in how the corresponding provisions of national patent law have been applied in the member states. As a result, some countries have adopted a rather liberal approach to patenting. For example, in the UK about 100 patents on hESC-based inventions had already been granted by 2009 [1]. Others, such as Germany at least with the first instance ruling of the German Federal Patent Court - have so far opted for a much more restrictive interpretation of the Directive.

The opinion of the Advocate General Yves Bot European Court of Justice: Image by SsolbergjIn his opinion the Advocate General made a suggestion on how Art. 6 (2) (c) of the Biopatent Directive and its terms should be understood. Bot rightly argues that the concept of a human embryo must be subject to a common understanding in all EU member states. Furthermore, he states clearly that hESC are not included in that concept, because they do not in themselves have the capacity to develop into a human being. Nevertheless, he surprisingly took a restrictive approach on patenting of hESC-based inventions: even inventions based on legally established hESC lines are excluded from patentability due to the fact that hESC lines are originally derived from fertilized human eggs.

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Stem cell patents: legal aspects | Europe's stem cell hub ...

While these scenarios may once have seemed like futuristic science fiction, advances in stem cell technology are bringing them closer to possibilities, if not to probabilities. In fact, desperate patients across the globe are traveling to countries such as China, Mexico, and the Dominican Republic to participate in unproven stem cell therapies."

Recently, stem cell science has made rapid progress, revealing entirely new scientific opportunities that will enable the development of future treatments for a wide variety of medical conditions. Many of these experimental or medical breakthroughs will have an unprecedented societal impact. It is imperative to carefully evaluate these developments from diverse viewpoints including ethical, legal, religious, economic, cultural, political, as well as scientific perspectives. Together, these disciplines will shape both public policy and personal health decisions.

We believe that cell biologists, clinicians, and bio- and neuro-ethicists can work together to celebrate advances, while simultaneously helping to inform and protect patients and the broader community concerning what might be considered inappropriate or premature applications of novel stem cell technologies. This will not be an easy process. We must engage in ongoing reasoned and informed discourse to ensure safe and appropriate innovations and applications of this new technology.

These modules were initially designed to accompany the Columbia University classroom course: "Stem Cells: Biology, Ethics, and Applications". We have now adapted the course to supplement any university course that focuses on stem cell research and potential medical and scientific applications. Undergraduate and graduate students as well as all others who have an interest in stem cell science, bioethical and social implications, and regulatory issues should find this course informative.

Within the eight Modules and Supplements of the online course, the reader will find:

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Emerging stem cell science reflects a dynamic and often opposing balance between rapidly progressing and diverse scientific discoveries, and a host of bioethical and societal concerns. Important issues are raised at every level and stage of research, from manipulating a somatic cell into a stem cell, to enrolling a patient in a stem cell clinical trial, to educating legislators and the public. We hope readers of this on-line course will have their curiosity stimulated by the myriad of important and complex ideas raised, and carefully consider the ethical dilemmas generated by stem cell science.

"Stem Cells: Biology, Bioethics, and Applications" is supported by a grant from the New York State STEM Cell Initiative (NYSTEM). It provides information on a range of important and complex topics about stem cell science. We believe students, professors, health care professionals, and the public alike will find the online multidisciplinary course on the current and future research of stem cell technologies and its applications informative and stimulating. The content of this online course was written and prepared by John D. Loike, Ph.D., Director of Special Programs, Center for Bioethics, Columbia University and Ruth L. Fischbach, Ph.D. M.P.E., Director, Center for Bioethics, Columbia University with special assistance from Janet Mindes, Ph.D., Consultant, Center for Bioethics, Columbia University.

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Main article: Stem cell laws

Stem cell laws and policy in the United States have had a complicated legal and political history.

Stem cells are cells found in all multi-cellular organisms. They were isolated in mice in 1981, and in humans in 1998.[1] In humans there are many types of stem cells, each with varying levels of potency. Potency is a measure of a cell's differentiation potential, or the number of other cell types that can be made from that stem cell. Embryonic stem cells are pluripotent stem cells derived from the inner cell mass of the blastocyst. These stem cells can differentiate into all other cells in the human body and are the subject of much scientific research. However, since they must be derived from early human embryos their production and use in research has been a hotly debated topic as the embryo most likely is destroyed in the process.

Stem cell treatments are a type of cell therapy that introduce new cells into adult bodies for possible treatment of cancer, diabetes, neurological disorders and other medical conditions. Stem cells have been used to repair tissue damaged by disease or age.[2]Cloning also might be done with stem cells. Pluripotent stem cells can also be derived from Somatic cell nuclear transfer which is a laboratory technique where a clone embryo is created from a donor nucleus. Somatic cell nuclear transfer is also tightly regulated amongst various countries.

Until recently, the principal source of human embryonic stem cells has been donated embryos from fertility clinics. In January 2007, researchers at Wake Forest University reported that "stem cells drawn from amniotic fluid donated by pregnant women hold much of the same promise as embryonic stem cells."[1]

In 2000, the NIH, under the administration of President Bill Clinton, issued "guidelines that allow federal funding of embryonic stem-cell research."[1]

In 1973, Roe v. Wade legalized abortion in the United States. Five years later, the first successful human in vitro fertilization resulted in the birth of Louise Brown in England. These developments prompted the federal government to create regulations barring the use of federal funds for research that experimented on human embryos.[3] In 1995, the NIH Human Embryo Research Panel advised the administration of President Bill Clinton to permit federal funding for research on embryos left over from in vitro fertility treatments and also recommended federal funding of research on embryos specifically created for experimentation. In response to the panel's recommendations, the Clinton administration, citing moral and ethical concerns, declined to fund research on embryos created solely for research purposes,[4] but did agree to fund research on left-over embryos created by in vitro fertility treatments. At this point, the Congress intervened and passed the Dickey-Wicker Amendment in 1995 (the final bill, which included the Dickey Amendment, was signed into law by Bill Clinton) which prohibited any federal funding for the Department of Health and Human Services be used for research that resulted in the destruction of an embryo regardless of the source of that embryo. In 1998, privately funded research led to the breakthrough discovery of human Embryonic stem cells (hESC). Stem cells are cells that have not differentiated yet.

No federal law ever did ban stem cell research in the United States, but only placed restrictions on funding and use, under Congress's power to spend.[5]

In February 2001, George W. Bush requested a review of the NIH's guidelines, and after a policy discussion within his circle of supporters, implemented a policy in August of that year to limit the number of embryonic stem cell lines that could be used for research.[1] (While he claimed that 78 lines would qualify for federal funding, only 19 lines were actually available.[1])

In April 2004, 206 members of Congress, including many moderate Republicans, signed a letter urging President Bush to expand federal funding of embryonic stem cell research beyond what Bush had already supported.

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Stem cell laws and policy in the United States - Wikipedia ...

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Diane T. Duffy, Congressional Research Service Updated June 12, 2002

Summary

With certain restrictions, the President has announced that federal funds may be used to conduct research on human embryonic stem cells. Federal research is limited to 64 1 existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. No federal funds will be used for the derivation or use of stem cell lines derived from newly destroyed embryos; the creation of any human embryos for research purposes; or cloning of human embryos for any purposes. Several lawsuits have been filed relating to stem cell research, and questions have been raised concerning access to existing stem cell lines by federal researchers.

Human Embryonic Stem Cells. Human embryonic stem cells are "master cells" and are able to develop into almost any cell in the human body. Building on earlier stem cell research, in 1998, researchers at the University of Wisconsin isolated cells from the inner cell mass of the early human embryo, called the blastocyst, and developed the first human embryonic stem cell lines. 2 Research has focused on the potential that these cells can offer to treat or mitigate diseases and conditions and to generate replacement tissues for disfunctioning cells or organs. 3 Research efforts have focused on spinal cord injury, multiple sclerosis, Parkinson's disease, Alzheimer's disease, diabetes, and other diseases or conditions. Scientists hope to use specialized cells to replace dysfunctional cells in the brain, spinal cord, pancreas, and other organs. 4 The sources for stem cells include: one week old embryos (blastocysts) created via in vitro fertilization (IVF) to treat infertility; five to nine week old embryos or fetuses obtained through elective abortion; embryos created through IVF for research purposes; embryos created through cloning or somatic cell nuclear transfer (SCNT); and adult tissues (umbilical cord blood, bone marrow). Controversy surrounds the derivation of stem cells from human embryos and fetuses. In order to derive or extract the stem cells found within the embryo, the embryo is destroyed in the removal process. The earliest embryonic stem cells are called totipotent cells, which means they can develop into an entire organism, producing both the embryo and tissues required to support it in the uterus. At a later stage of development, pluripotent embryonic stem cells exist and can develop into almost any type of cell in the body. These stem cells cannot form the supporting tissues, as seen with totipotent cells. 5 Human embryonic stem cells found in the early stage embryo are believed to have a greater ability to become different types of body cells and have more uses than adult stem cells.

Background and Recent Presidential and Congressional Action

Executive Action. When President Bush took office in January, 2001, he announced he would conduct a review of the stem cell research issue and ordered the Department of Health and Human Services (HHS) to review the National Institutes of Health's (NIH) guidelines issued by the former administration. During the review period, NIH suspended its review of applications from researchers seeking federal funds to perform human embryonic stem cell research. On August 9, 2001, President Bush announced that federal funds would be available to support limited human embryonic stem cell research. The new policy provides that federal funds may be used for research on 64 existing stem cell lines that have already been derived or were already in existence as of the date of the announcement. In identifying the 64 stem cell lines as being eligible for federal funding, the President said these embryos, from which the existing stem cell lines were created, had been destroyed previously and could not develop as human beings.

Under the new policy, federal agencies, primarily NIH, will consider applications for funding if certain standards or eligibility criteria are met. The White House fact sheet setting forth the President's policy states: federal funds will only be used for research on existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. 6 The President directed NIH to examine the derivation of all existing stem cell lines and create a registry of those lines. Pursuant to this new policy, no federal funds will be used for: (1) the derivation or use of stem cell lines derived from newly destroyed embryos; (2) the creation of any human embryos for research purposes; or (3) cloning of human embryos for any purposes. The new policy replaces previously issued stem cell guidelines and policies. The policy also requires the creation of the President's Council on Bioethics to study stem cells and embryo research as well as other issues. NIH has listed entities that have developed stem cells lines that meet the President's criteria and are eligible for federal funding (the Human Embryonic Stem Cell Registry). The President also stated that in FY2001, the government will spend $250 million on research involving stem cells from other sources, e. g., umbilical cord, placenta, adult and animal tissues.

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Background and Legal Issues Related to Stem Cell Research

Stem cell laws are the law rules, and policy governance concerning the sources, research, and uses in treatment of stem cells in humans. These laws have been the source of much controversy and vary significantly by country.[1] In the European Union, stem cell research using the human embryo is permitted in Sweden, Finland, Belgium, Greece, Britain, Denmark and the Netherlands; however, it is illegal in Germany, Austria, Ireland, Italy, and Portugal. The issue has similarly divided the United States, with several states enforcing a complete ban and others giving financial support.[2] Elsewhere, Japan, India, Iran, Israel, South Korea, China, and Australia are supportive. However, New Zealand, most of Africa (except South Africa), and most of South America (except Brazil) are restrictive.

The information presented here covers the legal implications of embryonic stem cells (ES), rather than induced pluripotent stem cells (iPSCs). The laws surrounding the two differ because while both have similar capacities in differentiation, their modes of derivation are not. While embryonic stem cells are taken from embryoblasts, induced pluripotent stem cells are undifferentiated from somatic adult cells.[3]

Stem cell are cells found in most, if not all, multi-cellular organisms. A common example of a stem cell is the Hematopoietic stem cell (HSC) which are multipotent stem cells that give rise to cells of the blood lineage. In contrast to multipotent stem cells, embryonic stem cells are pluripotent and are thought to be able to give rise to all cells of the body. Embryonic stem cells were isolated in mice in 1981, and in humans in 1998.[4]

Stem cell treatments are a type of cell therapy that introduce new cells into adult bodies for possible treatment of cancer, Somatic cell nuclear transfer, diabetes, and other medical conditions. Cloning also might be done with stem cells. Stem cells have been used to repair tissue damaged by disease.[5]

Because Embryonic Stem (ES) cells are cultured from the embryoblast 45 days after fertilization, harvesting them is most often done from donated embryos from in vitro fertilization (IVF) clinics. In January 2007, researchers at Wake Forest University reported that "stem cells drawn from amniotic fluid donated by pregnant women hold much of the same promise as embryonic stem cells."[4]

In 2000, the NIH, under the administration of President Bill Clinton, issued guidelines that allow federal funding of embryonic stem-cell research.[4]

The European Union has yet to issue consistent regulations with respect to stem cell research in member states. Whereas Germany, Austria, Italy, Finland, Greece, Ireland, Portugal and the Netherlands prohibit or severely restrict the use of embryonic stem cells, Sweden and the United Kingdom have created the legal basis to support this research.[6]Belgium bans reproductive cloning but allows therapeutic cloning of embryos.[1]France prohibits reproductive cloning and embryo creation for research purposes, but enacted laws (with a sunset provision expiring in 2009) to allow scientists to conduct stem cell research on imported a large amount of embryos from in vitro fertilization treatments.[1]Germany has restrictive policies for stem cell research, but a 2008 law authorizes "the use of imported stem cell lines produced before May 1, 2007."[1]Italy has a 2004 law that forbids all sperm or egg donations and the freezing of embryos, but allows, in effect, using existing stem cell lines that have been imported.[1]Sweden forbids reproductive cloning, but allows therapeutic cloning and authorized a stem cell bank.[1][6]

In 2001, the British Parliament amended the Human Fertilisation and Embryology Act 1990 (since amended by the Human Fertilisation and Embryology Act 2008) to permit the destruction of embryos for hESC harvests but only if the research satisfies one of the following requirements:

The United Kingdom is one of the leaders in stem cell research, in the opinion of Lord Sainsbury, Science and Innovation Minister for the UK.[7] A new 10 million stem cell research centre has been announced at the University of Cambridge.[8]

The primary legislation in South Africa that deals with embryo research is the Human Tissue Act, which is set to be replaced by Chapter 8 of the National Health Act. The NHA Chapter 8 has been enacted by parliament, but not yet signed into force by the president. The process of finalising these regulations is still underway. The NHA Chapter 8 allows the Minister of Health to give permission for research on embryos not older than 14 days. The legislation on embryo research is complemented by the South African Medical Research Council's Ethics Guidelines. These Guidelines advise against the creation of embryos for the sole purpose of research. In the case of Christian Lawyers Association of South Africa & others v Minister of Health & others[9] the court ruled that the Bill of Rights is not applicable to the unborn. It has therefore been argued based on constitutional grounds (the right to human dignity, and the right to freedom of scientific research) that the above limitations on embryo research are overly inhibitive of the autonomy of scientists, and hence unconstitutional.[10]

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Stem cell laws - Wikipedia, the free encyclopedia

Stem Cells

A stem cell is essentially a blank cell, capable of becoming another more differentiated cell type in the body, such as a skin cell, a muscle cell, or a nerve cell. Microscopic in size, stem cells are big news in medical and science circles because they can be used to replace or even heal damaged tissues and cells in the body. They can serve as a built-in repair system for the human body, replenishing other cells as long as a person is still alive.

Adult stem cells are a natural solution. They naturally exist in our bodies, and they provide a natural repair mechanism for many tissues of our bodies. They belong in the microenvironment of an adult body, while embryonic stem cells belong in the microenvironment of the early embryo, not in an adult body, where they tend to cause tumors and immune system reactions.

Most importantly, adult stem cells have already been successfully used in human therapies for many years. As of this moment, no therapies in humans have ever been successfully carried out using embryonic stem cells. New therapies using adult type stem cells, on the other hand, are being developed all the time.

Source: 2010 Stemcellresearchfacts.org

Cloning-to-produce-children Production of a cloned human embryo, formed for the (proximate) purpose of initiating a pregnancy, with the (ultimate) goal of producing a child who will be genetically virtually identical to a currently existing or previously existing individual.

Cloning-for-biomedical-research - Production of a cloned human embryo, formed for the (proximate) purpose of using it in research or for extracting its stem cells, with the (ultimate) goals of gaining scientific knowledge of normal and abnormal development and of developing cures for human diseases.

Human cloning The asexual reproduction of a new human organism that is, at all stages of development, genetically virtually identical to a currently existing, or previously existing, human being. (CR)

Cloned embryo: An embryo arising from the somatic cell nuclear transfer process as contrasted with an embryo arising from the union of an egg and sperm. (CR)

Source: White Paper: Alternative Sources of Pluripotent Stem Cells The Presidents Council on Bioethics Washington, D.C., May 2005

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Stem Cells and Cloning | New Jersey Right to Life ...

Stem Cell Research in Jewish Law Daniel Eisenberg, MD

Stem cell research is among the most promising and controversial technological breakthroughs of our time. Most cells in the human body are differentiated and, if they maintain the ability to divide at all, have the ability to form only cells similar to themselves. Stem cells have the unique property of being able to divide, while maintaining their totipotent or pluripotent characteristics. Early in mammalian development, stem cells (under the proper conditions) have the ability to differentiate into every cell of the human body (totipotent), potentially forming an entire fetus. Stem cells derived from later stages of mammalian development have the ability to differentiate into multiple cell types, but not into an entire organism. If we were able to manipulate the conditions controlling cellular differentiation, we might be able to create replacement cells and organs, potentially curing illnesses such as diabetes, Alzheimer's disease, and Parkinson's disease.

The ultimate promise of stem cell technology would be to combine it with cloning. Imagine a man dying of liver failure. If we could take a somatic cell from his skin and place the nuclear DNA into a denucleated egg cell, we would have created an almost exact copy[1] of that sick man's cell, capable of differentiating into his clone. Instead of allowing the cloned cell to develop into a fetus, we might place it (or its stem cells alone) into the appropriate environment that would cause it to differentiate into a liver that would be virtually genetically identical to the sick man. If we could "grow" this liver to maturity, we could offer the sick man a liver transplant without the risk of rejection and without the need for anti-rejection drugs.

This sounds like a virtual panacea for many of man's ills. Yet we still do not know if we are able to successfully clone a human, nor are we sure what practical value can be derived from stem cells. We are currently in the realm of fascinating speculation. It will require years of very expensive, labor intensive research to determine the potential that stem cells hold for the treatment, palliation, and cure of human illness. While stem cells have been isolated from adults and aborted fetuses, the best source is the "pre-embryo," the small clump of cells that compose the early zygote only a few days following conception. Therefore, to best investigate the latent possibilities inherent in stem cells, scientists wish to use the approximately 100,000 "excess" frozen pre-embryos that are "left over" from earlier IVF attempts.

What is the halachic perspective on such research and what could the possible objections to such research be? There is little argument that the use of stem cells derived from adult somatic tissue pose few ethical problems. The issues raised by stem cell research involve the use of in vitro fertilized eggs which have not yet been implanted in a woman and the use of tissue from aborted fetuses.

The issues raised by stem cell research may be divided into several questions:

Artificial insemination has been dealt with a length by a spectrum of poskim (rabbis qualified to decide matters of Jewish law). While artificial insemination by a donor is generally strongly condemned, the use of a husband's sperm for artificial insemination in cases of necessity was accepted by most Rabbinical authorities.[2] The question of in vitro fertilization was dealt with later. A significant majority of authorities accepted in vitro fertilization under the same rubric and limitations as artificial insemination,[3] including the fulfillment of the mitzvah of procreation.[4] However, a fundamentally new question arose. What is the status of the "spare" embryos that are not implanted as part of the first cycle of IVF?[5] Must they be implanted in the mother as part of another attempt at pregnancy. May/must they be donated to another women to allow the pre-embryo its chance at life? May they remain frozen indefinitely?[6] Most importantly to our topic, the question arose - may pre-embryos be destroyed? To answer this question, we must first generally examine the Jewish approach to abortion.

Abortion in Jewish Law

The traditional Jewish view of abortion does not fit conveniently into either of the major "camps" in the current American abortion debate. We neither ban abortion completely, nor do we allow indiscriminate abortion "on demand." To gain a clear understanding of when abortion is sanctioned, or even required, and when it is forbidden, requires an appreciation of certain nuances of halacha (Jewish law) which govern the status of the fetus.

The easiest way to conceptualize a fetus in halacha is to imagine it as a full-fledged human being - but not quite. In most circumstances, the fetus is treated like any other "person." Generally, one may not deliberately harm a fetus, and sanctions are placed upon those who purposefully cause a woman to miscarry. However, when its life comes into direct conflict with an already born person, the autonomous person's life takes precedence.

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Jewish Law - Articles - Stem Cell Research in Jewish Law

A paper presented to the Oxford Society of Scholars Forum by Rollin A. Van Broekhoven, JD, LLM, DPhil, DLitt, DPS 29 September 2001

INTRODUCTION

In 1729, when the Irish were crushed by poverty, thanks to the brutal economic policies of their English overlords, Jonathan Swift the conservative Irish clergyman who became the worlds greatest satirist wrote up A Modest Proposal. In deadpan prose and in a kindly benevolent style, he suggested that Irish babies be sold for food. That way, he argued, there would be both more food to go around and fewer mouths to feed. Besides, baby skin would make a really soft leather, making possible a new industry that would create jobs and boost the Irish economy.

Swift, the Christian pastor, was lampooning the moral utilitarianism of the Enlightenment, which taught that anything could be morally justified if it were useful giving the greatest tangible benefit to the greatest number. Swift showed where this kind of thinking, if pursued logically, would lead. Indeed, his A Modest Proposal did wake up the conscience of a good number of his readers, who realized that no noble social end could possibly justify the consumption of babies, and no moral philosophy that could justify such a thing could possibly be valid.

...Thinking about moral issues in utilitarian terms has become so ingrained that many Americans are unable to think in any other terms. If something no matter how reprehensible has a positive outcome, it must be okay.1

This paper addresses issues concerning the utilization of human embryonic stem cells in research. Although research also involves adult stem cells, such research does not at the present confront society with the same ethical and legal issues present in human embryonic stem cell research. Two great questions confront the human race at the start of this biotech century.2 The first is whether we should use members of our own kind, namely, Homo Sapiens, in whatever stage of biological existence, for the purpose that is other than the good of the individual concerned. The second, perhaps only in the horizons of our thinking, is whether we should use our growing capacity to design, determine, and transform ourselves and our nature, toward a so-called post-human future.3 What is at stake is societys understanding of what it means to be human. Nevertheless, underlying consideration of this subject are the following questions: If a procedure or process is scientifically or technologically feasible, is it, or should it be morally permissible, or at least be regarded as morally neutral?4 If it is morally permissible or neutral, is it, or should it be legally permissible? For many of us, these questions are intensely personal as we deal with bioethical end of life or incurable disease issues in our own families.

The relation of the natural sciences and morality and religion and law is one of the most fascinating, challenging, controversial, and potentially enriching studies possible in contemporary Western life. At its broadest and most general meaning, science is knowledge that is accumulated, systematized, and formulated with reference to the discovery of general truths or the operation of general laws. At this level, a distinction must be made between the natural or physical sciences, such as physics, chemistry, or biology, and the normative sciences, such as the social sciences. A more specific definition of the natural science may be that it is any systematic field of study or body of knowledge that aims, through experimentation, observation and deduction to produce a reliable explanation of phenomena with reference to the material or physical world.5 Philosophy of science deals, in very general terms, with the philosophical issues associated with the natural sciences.6

The natural sciences tended to be neutral towards religion. They did not require prior or consequent acceptance or rejection of any religious beliefs. As a result, most natural scientists assume that considerations of divine influence upon or involvement within natural order are largely irrelevant to the specific task searching for a natural explanation to patterns observed in nature. A significant philosophical distinction important to understanding the development of the natural sciences concerns rationalism and empiricism.7

On the one hand, rationalism with its emphasis on reason and view that all truth has its origins in human thought, unaided by any form of supernatural intervention or appeal to the experience of the senses, promoted the view that certain truths were universal and necessary. The alternative to rationalism, on the other hand, was an appeal to experience, generally known as empiricism. The issue emerging from the debate between rationalism and empiricism is whether certain truths (assuming there is such a thing as truth) are a priori or a posteriori. The same debate exists in religion and in moral thought, namely is the knowledge of God a priori, implanted there by God, or a posteriori, derived by reflection on experience or divine revelation. How one approaches the question of the morality of stem cell research is in large measure derived from ones a priori understanding of the nature of God and His commands, or ones a posteriori understanding of God based on ones experiences, including experience with God.

Where once there was a dialogue between religion and science, with certain shared assumptions, now there is a growing sense of conflict between religion and science. While the nature and the reasons for this conflict are beyond the scope of this paper, there are four considerations that may be noted that reflect the growing realization of insecurity in the inherited assumptions on which prior prevailing understandings rested.8 These include: the cultural shift reflected in the rise of postmodernism; the growing dissatisfaction with philosophical foundationalism; the influence of the negative direction of the conflict models and imageries; and the tendency to perpetuate outdated and misleading stereotypes often dependent upon incorrect assumptions, findings, and assertions in earlier works.9

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Stem Cell Research, Morality, and Law

Today, a man lies dying of liver failure in a hospital. There is little expectation that he will be one of the lucky few to receive a transplant before he becomes too ill to save. Even if he did receive a transplant, he will be burdened with taking multiple anti-rejection drugs for the rest of his life, which in and of themselves would significantly compromise his health.

Tomorrow, scientists develop a method to build this man a new liver, one that would be a perfect match for him, requiring no anti-rejection drugs whatsoever. There is a catch. To perfect such a solution would require the destruction of other lives. Would Judaism sanction such a solution?

Jewish law clearly forbids the taking of one life to save another. The Talmud forbids saving one's life at the expense of another by asking how one knows that his life is more valuable than his neighbor's. Perhaps your neighbor's life is more valuable.

When The Fetus Is A Threat To Life

But, what if the life that would need to be sacrificed was that of a fetus? May we permit abortion to save the life of an already born person? The Mishna clearly states that if the life of a woman in labor is threatened by her fetus, the fetus should be aborted. But once a portion of the baby has emerged, we may not abort the fetus, because "one may not set aside one person's life for the sake of another."

The principle behind this ruling is that one may kill someone who is unjustly pursuing a third party to kill him. Since the fetus, who is not yet considered a "complete" person, is "pursuing" the mother in a way that will inevitably result in her death, we may kill it first. But, once it has even partially emerged, it is considered a full-fledged person. Now we are faced with a dilemma, states Rabbi Moshe Feinstein, one of the most respected rabbis of the 20th century: who is pursuing whom?

When Pursuing Each Other

Imagine that you are transported back in time to Weehawken, New Jersey, on July 11, 1804. As you step out of the time machine you see Aaron Burr, pulling out a revolver to shoot Alexander Hamilton, former U.S. Treasury Secretary. Simultaneously, you see Hamilton also drawing his revolver to kill Burr! What should you do? Kill Burr? Kill Hamilton? Jewish law would rule that you may kill neither, because they are pursuing each other and you do not know which one, if either, is an innocent party.

In our case of the baby struggling to be born at the expense of the mother and the mother struggling to survive at the expense of the fetus, are not the baby and the mother each "pursuing" the other? In such a case, the general rule is that we may not choose either, since each is a complete and autonomous person, and each is both the pursuer and the pursued. Luckily for us, these scenarios are very rare occurrences in our day thanks to Caesarian sections.

But, since the rationale for abortion in Jewish law is based on the fetus being a pursuer of the mother, a life-threatening situation for another adult would not justify our killing a fetus, since the fetus does not threaten the life of anyone except the mother. Therefore, we cannot allow abortion, even to save the life of our patient with liver failure.

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Is Stem Cell Research Ethical ? Ethical issues stem cell ...

In the US, legislation and funding for stem cell research are closely entwined. At a federal level, scientists can't use government money to create new embryonic stem cell lines. All publicly funded work is confined to the 61 stem cell lines already in existence in 2001, when the ban on deriving new lines was implemented.

In July 2006 President Bush vetoed a Bill lifting that ban, based on his opposition to the use of public funds for projects involving the destruction of human embryos - the first time in his presidency he had refused to sign into law a Bill approved by Congress. Individual states have the authority to pass laws to permit human embryonic stem cell research using state funds. Several states have changed their legislation accordingly, including Connecticut, Massachusetts, California, and Illinois. This has enabled the establishment of California's $3 billion Institute for Regenerative Medicine.

Private funding of embryonic stem cell research in the US has never been prohibited leaving this sector largely unregulated.

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Stem Cells and the law - Europe's stem cell hub | EuroStemCell

Many countries around the world have enacted laws to govern stem cell research (SCR) (see map). Stem cell laws are commonly found in dedicated statutes (for e.g., in Australia and Germany) or in legislation which deals primarily with reproductive technologies (such as in vitro fertilization (IVF)) and related research (as is the case in Canada and the United Kingdom).

Most SCR laws also place criminal sanctions on various research activities, especially those that raise unresolved social, scientific, ethical, and legal questions (such as the controversy over the moral and legal status of the embryo, and over whether embryos should be used for scientific research). Some of the SCR techniques covered in stem cell legislation include the derivation of stem cells from spare human embryos remaining after the IVF process is completed, the creation of human embryos for stem cell derivation, somatic cell nuclear transfer (SCNT), and inter-species somatic cell nuclear transfer (SCNT, using animal ova).

There is a great deal of variation in the laws governing SCR in countries around the world. Such variations exist even among countries with similar socio-political, economic, and cultural environments, such as Canada, Australia, the United States, Germany, and the United Kingdom. Stem cell laws range from restrictive to permissive policies depending on the number of restrictions placed on various SCR techniques. Canadian law (The Assisted Human Reproduction Act), is classified as intermediate because it allows some research practices (research on spare IVF embryos, animal-human hybrid embryos, etc.) while prohibiting others with criminal sanctions (creation of embryos for research, somatic cell nuclear transfer, etc.). Countries on the permissive end of the legislative spectrum include the United Kingdom, Israel and Singapore, and on the restrictive end, there is Germany, France and Italy.1 The United States is in a unique position with respect to stem cell regulation while there is no explicit legislation at the federal level governing SCR, current U.S. federal executive policy forbids the use of public funds for many SCR activities. However, several states, such as California, New Jersey, and Massachusetts have passed legislation which can be described as permissive.

What kind of matters are covered in stem cell research legislation?

Irrespective of the range of research techniques allowed, most legislation provide for a strict oversight and licensing scheme. What this means is that researchers must first obtain a license from a government regulator (such as Health Canada and the U.K. Human Fertilisation and Embryology Authority) before engaging in research, and must conduct their research in accordance with strict guidelines laid down by the government regulator or in research ethics documents (such as the Canadian Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans). These guidelines include substantive, procedural and ethical safeguards which serve to ensure research integrity, protect research participants, and promote the safe and ethical conduct of research.2 In the case of embryo-based stem cell research, most (if not all) stem cell laws prohibit the implantation of research embryos in humans, as well as the development of the embryo beyond a certain period after fertilization (usually 14 days, or until the appearance of the primitive streak, whichever is earlier).

Unresolved issues

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Stem Cell Research and the Law | Hinnovic

Stem cells are undifferentiated biological cells that can differentiate into specialized cells and can divide (through mitosis) to produce more stem cells. They are found in multicellular organisms. In mammals, there are two broad types of stem cells: embryonic stem cells, which are isolated from the inner cell mass of blastocysts, and adult stem cells, which are found in various tissues. In adult organisms, stem cells and progenitor cells act as a repair system for the body, replenishing adult tissues. In a developing embryo, stem cells can differentiate into all the specialized cellsectoderm, endoderm and mesoderm (see induced pluripotent stem cells)but also maintain the normal turnover of regenerative organs, such as blood, skin, or intestinal tissues.

There are three known accessible sources of autologous adult stem cells in humans:

Stem cells can also be taken from umbilical cord blood just after birth. Of all stem cell types, autologous harvesting involves the least risk. By definition, autologous cells are obtained from one's own body, just as one may bank his or her own blood for elective surgical procedures.

Adult stem cells are frequently used in medical therapies, for example in bone marrow transplantation. Stem cells can now be artificially grown and transformed (differentiated) into specialized cell types with characteristics consistent with cells of various tissues such as muscles or nerves. Embryonic cell lines and autologous embryonic stem cells generated through Somatic-cell nuclear transfer or dedifferentiation have also been proposed as promising candidates for future therapies.[1] Research into stem cells grew out of findings by Ernest A. McCulloch and James E. Till at the University of Toronto in the 1960s.[2][3]

The classical definition of a stem cell requires that it possess two properties:

Two mechanisms exist to ensure that a stem cell population is maintained:

Potency specifies the differentiation potential (the potential to differentiate into different cell types) of the stem cell.[4]

In practice, stem cells are identified by whether they can regenerate tissue. For example, the defining test for bone marrow or hematopoietic stem cells (HSCs) is the ability to transplant the cells and save an individual without HSCs. This demonstrates that the cells can produce new blood cells over a long term. It should also be possible to isolate stem cells from the transplanted individual, which can themselves be transplanted into another individual without HSCs, demonstrating that the stem cell was able to self-renew.

Properties of stem cells can be illustrated in vitro, using methods such as clonogenic assays, in which single cells are assessed for their ability to differentiate and self-renew.[7][8] Stem cells can also be isolated by their possession of a distinctive set of cell surface markers. However, in vitro culture conditions can alter the behavior of cells, making it unclear whether the cells will behave in a similar manner in vivo. There is considerable debate as to whether some proposed adult cell populations are truly stem cells.

Embryonic stem (ES) cells are stem cells derived from the inner cell mass of a blastocyst, an early-stage embryo.[9] Human embryos reach the blastocyst stage 45 days post fertilization, at which time they consist of 50150 cells. ES cells are pluripotent and give rise during development to all derivatives of the three primary germ layers: ectoderm, endoderm and mesoderm. In other words, they can develop into each of the more than 200 cell types of the adult body when given sufficient and necessary stimulation for a specific cell type. They do not contribute to the extra-embryonic membranes or the placenta.

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Stem cell - Wikipedia, the free encyclopedia

Wednesday, Oct. 17, 2012

Nobel laureate Shinya Yamanaka has been awash with admiration, receiving offers of financial support for his research on induced pluripotent stem cells, and now he may get an unlikely gift from members of the government.

Science and education minister Makiko Tanaka said Tuesday she has proposed that Cabinet ministers present Yamanaka with a new washing machine.

The offer comes after it was learned that Yamanaka, a 50-year-old professor at Kyoto University, was in the middle of repairing his washing machine when he got the phone call on Oct. 8 to tell him that he had won the 2012 Nobel Prize in physiology or medicine.

"I suggested that we split the cost (of a new washing machine) among Cabinet ministers," Tanaka revealed at a news conference.

Tanaka said a contribution of 5,000 to 10,000 each from the 19 Cabinet members would probably be enough to buy a new washer.

No one objected to her proposal, according to Tanaka.

Still, she noted, before making such an offer, the ministers need to check whether there are any legal issues involved.

JIJI

Shinzo Abe, president of the Liberal Democratic Party, denied having any deep ties with a man linked to a yakuza syndicate.

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Ministers may split cost of new washing machine for Yamanaka: Tanaka

An important issue pushed into the background.

Stem cell issues: still important issues. Photograph: Getty Images

In a US election year dominated by economic issues, research using human embryonic stem cells (hESC) has received far less attention in 2012 than in previous election years just another social debate pushed into the background, despite its ethical controversy and the fact that it could have major implications for the treatment of conditions as serious and widespread as diabetes, cancer, heart disease and dementia.

Although stem cell research isn't exactly on top of this year's election agenda, the result when America goes to the polls on 6 November could have a major impact on hESC research in the US. The main issue at hand is not whether embryonic stem cell research should be banned both Obama and Romney agree that this research is legal but whether it should be federally funded through the National Institutes of Health (NIH).

President Obama has effectively made his position clear during his time in office. In 2009, he reversed a directive from his predecessor George W Bush that denied federal funding to research on any stem cells created after 2001, limiting researchers to the 21 stem cell lines (a family of constantly dividing cells) that had been derived from embryos up to that point. Obama's legislation re-opened the 1,000 or more stem cell lines that have been created since then to federally-funded research, a move welcomed by the scientific community and condemned by pro-life campaigners and conservative Republicans.

In reality, despite Obama's 2009 legislation, under the Dickey-Wicker amendment introduced in 1996 it is still illegal in the US to pursue any research that involves the creation, destruction or discarding of human embryos, meaning that although American scientists can conduct research on stem cell lines derived from embryos, they are barred from using embryos to create their own lines. The Dickey-Wicker amendment remains an obstacle to embryonic stem cell research in the US and it's unclear if the president would have the clout to do away with it if re-elected.

Romney's personal view on hESC seems to broadly follow the pro-life stance of his party; he supports stem cell research in general, but opposes the destruction of embryos for the purpose. In a Republican presidential candidates' debate for the last election in 2007, Romney stated that he wouldn't use federal funds to finance hESC research. This would essentially take the US back to the same situation as under George W Bush, and there's no reason to think that Romney has changed his position between 2007 and now.

The Republican candidate has consistently extolled the benefits of adult and umbilical cord stem cells, which, he asserts, provide the benefits of creating pluripotent cells without the "moral shortcut" of destroying an embryo in the process. Alternatives to embryonic stem cell research are Romney's perfect political solution, allowing him to appear to support stem cell research without losing the religious right by excusing the destruction of embryos.

From a scientific standpoint, his position is less tenable. Researchers have said that the development of non-embryonic stem cell types is actually dependent on embryonic stem cell research as a complementary process. So by plugging adult stem cell research alternatives as the exclusive answer to the field's ethical issues, Romney may be unwittingly damaging their development by depriving researchers of important side-by-side embryonic research.

Whatever the outcome of the elections on 6 November, the US is unlikely to live up to its stem cell research potential when compared to world leaders in the field. If Obama wins, there will at least be federal funding to study existing embryonic stem cells, but the Dickey-Wicker amendment will maintain the ban on creating new stem cell lines. If Romney turns the tide and emerges on top, American stem cell researchers will likely have to suffer through four more years in the unfunded wilderness.

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Stem cells: this election's neglected child

By Dennis Normile, ScienceNOW

Want baby mice? Grab a petri dish. After producing normal mouse pups last year using sperm derived from stem cells, a Kyoto University team of researchers has now accomplished the same feat using eggs created the same way. The study may eventually lead to new ways of helping infertile couples conceive.

This is a significant achievement that I believe will have a sustained and long-lasting impact on the field of reproductive cell biology and genetics, says Amander Clark, a stem cell biologist at University of California, Los Angeles.

The stem cells in both cases are embryonic stem (ES) cells and induced pluripotent stem (iPS) cells. The former are taken from embryos and the latter are adult tissue cells that are reprogrammed to act like stem cells. In theory, both can produce all of the bodys cell types, yet most researchers have been unable to turn them into germ cells, precursors of sperm and eggs.

The Kyoto group, led by stem cell biologist Mitinori Saitou, found a process that works. As with the sperm, the group started with ES and iPS cells and cultured them in a cocktail of proteins to produce primordial germ cell-like cells. To get oocytes, or precursor egg cells, they then mixed the primordial cells with fetal ovarian cells, forming reconstituted ovaries that they then grafted onto natural ovaries in living mice. Four weeks and 4 days later, the primordial germ cell-like cells had developed into oocytes. The team removed the ovaries, harvested the oocytes, fertilized them in vitro, and implanted the resulting embryos into surrogate mothers. About 3 weeks later, normal mouse pups were born, the researchers report online today in Science.

It is remarkable that one can produce oocytes capable of sustaining complete development starting with embryonic stem cells, says Davor Solter, a developmental biologist at Singapores Institute of Medical Biology. Clark adds that the immediate impact of the work will be on understanding the molecular mechanisms involved in forming germ cells. Saitou says that with a bit more progress in understanding the complex interactions at work, they may be able to coax the cells through the entire oocyte development process in a lab dish. If successful, we may be able to skip the grafting, he says.

Further in the future, the technique could lead to a new tool for treating infertility. This study has provided the critical proof of principle that oocytes can be generated from induced pluripotent stem cells, Clark says. If applied to humans, it could lead to the ability to create oocytes from iPS cells taken from infertile women. But Saitou cautions that moving on to human research will require resolving thorny ethical issues and technical difficulties. Solter says that at the extreme, the new approach could lead to the production of human embryos from cell lines and tissue samples. Still, he notes, defining the status of such parentless human embryos and the biological, ethical, and legal issues they will raise defies the imagination.

This story provided by ScienceNOW, the daily online news service of the journal Science.

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Dish-Grown Sperm and Eggs Produce Mouse Pups

HOUSTON, June 27, 2012 /PRNewswire/ --After an invitation from Celltex Therapeutics Corp., the Food and Drug Administration (FDA) visited the Celltex laboratory for two weeks in April, 2012. TheFDA studied Celltex operations in depth in accordance with the "good tissue practices" (GTP) standards, as it routinely does with inspections of facilities such as Celltex which are registered pursuant to 21 CFR Part 1271. In their close-out report given to Celltex on the last day of their visit, the FDA had 14 main observations that it requested Celltex resolve.

Celltex has worked closely withtheFDA both during its visit and since to provide requested details and documentationto answer its questions. We have resolved many of the FDA observations, and we are working to address the remainder. We have an open line of communication with the FDAand expect to maintain that in our cooperative relationship.

Celltex continues to provide stem cell banking and multiplication services without interruption and has not received any disciplinary action from the FDA.

Celltex's laboratory is currently operated by its licensing partner RNL Bio (dba Human Biostar), with lab technicians and scientists from RNL's Seoul, Korea headquarters. The main issues in the FDA observations arose from a language barrier. RNL scientists extensively document procedures, including validations, but they are recorded in Korean and were not able to be provided in English to FDA during its visit. Since the FDA's visit, the RNL procedures and other documents have been translated to English by an independent, professional translation service, and supplied to the agency. We are confident that the translated documents demonstrate the thoroughly validated scientific process that underpins the Celltex laboratory operations.

Celltex continues to strengthen its documentation and laboratory operations and has added to its staff Celltex personnel experienced in U.S. FDA compliance.

Some media reports and social media chatter suggest that Celltex is somehow acting illegally or providing unapproved treatments. These statements are inaccurate. Celltex is registered with the FDA as a facility that multiplies human cells and cellular products (HCT/Ps); in particular, adult mesenchymal stem cells. The FDA does not require a company to obtain FDA approval prior to distribution of its HCT/Ps. 21 CFR Part 1271. In addition, the FDA does not issue "licenses," so any reference that Celltex provides "unlicensed" procedures is inaccurate. Celltex's process for reproducing adult mesenchymal stem cells is legal, and there is no requirement that the cells be approved or licensed.

Celltex ensures that all of the cells it provides to physicians for therapeutic use are sterile, viable, intact mesenchymal stem cells. RNL's quality control scientists examine each patient's cells for their integrity and sterility prior to release, documenting those findings. Celltex and its partner RNL Bio process stem cells in a safe, sterile laboratory with procedures that ensure cell viability and integrity.

Celltex has taken the initiative to make autologous adult mesenchymal stem cell multiplication services available to physicians outside of academia for use with their patients. Celltex firmly believes in the great therapeutic potential for autologous mesenchymal stem cell multiplication services in regenerative medicine.

For more information, contact Celltex, 713-590-1000.

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Celltex Responds to Media Reporting on FDA Visit

Last year Peyton Manning flew to Europe on a private jet, not for tea and crumpets or to see the Louvre, but for an experimental stem-cell treatment on his injured neck.

The procedure, one that isn't even legal in the United States, allegedly took his own fat cells and used them to try to regrow damaged neck tissue:

"There are many proposed therapies that are being tested in clinical trials, and there are more to come," Dr. Lawrence Goldstein, director of the stem cell program at the University of California, San Diego, told ABC News. "But in the absence of reliable evidence, it is impossible to know whether the 'treatment' will make Manning better or worse or merely financially poorer."

TheNFL doesn't have any rules specifically banning illegal procedures that an athlete can have done in foreign locales. Kobe Bryant, the NBA's aging lion, had similarly cutting-edge treatment on his arthritic knee in Germany. It's called "Biologic Medicine,"and in addition to Bryant, super-agent Ari Emanueland the late Pope John Paul II were ardent believers.

There are a ton of controversial treatments possible where science collides with loose regulation. Bone marrow injections filled with those miracle-working stem cells can be injected into the body. Blood can be heated up, spun and spun in an incubator, the healing agents isolated and injected. The 34-year-old Bryant felt like a new man after first undergoing the procedure, like Manning's one not approved by the FDA:

He even recommended the treatment to Alex Rodriguez, which led the baseball star to undergo the same treatment on his knee late last year. Bryant hasn't commented publicly on the treatment, but A-Rod has described the feelings of his friend.

Bryant "was really adamant about how great the procedure was for him," Rodriguez told reporters."I know that he was hurting before, almost even thinking about retirement, that's how much pain he was under. And then he said after he went to Germany he felt like a 27-year-old again. I was still a little apprehensive about it, and he kept staying on me about it."

Athletes at the highest levels will do almost anything to maintain that edgeto feel younger, sprier and as explosive as they did in their primes. And with the right money and resources, they are extending their careers further than any of their predecessors would have dared dream. Is it any wonder athletes in mixed martial arts are doing the same?

Frank Mir on TRT

In that sport, some of the UFC's top aging stars have undergone Testosterone Replacement Therapy (TRT), looking to bring their bodies' natural level of testosterone back to the levels they enjoyed in their 20s. Top contenders like Dan Henderson (41), Chael Sonnen (35) and Frank Mir (33)have all undergone the procedure. Former middleweight champion Rich Franklin (37)is considering it.

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The UFC's Supposed Testosterone Epidemic: Critics Living in the Past

COMMENTARY | The ever-heated abortion debate brings out the beast in both sides. Occasionally, key quotes from one side may actually advance the cause of the other, as the latest controversy suggests. Maybe this one just makes the issues more obvious.

Headlines exploded after two ethicists published "After-birth abortion: Why should the baby live?" in the Journal of Medical Ethics (JME), a British medical journal February 23.

The authors, Alberto Giubilini and Francesca Minerva, essentially said no ethical difference exists between a fetus and a newborn. Either both are real humans or neither are. Following this logic, abortion and infanticide would be considered equal.

"Merely being human is not in itself a reason for ascribing someone a right to life," the article read. "Many humans are not considered subjects of a right to life: spare embryos where research on embryo stem cells is permitted, fetuses where abortion is permitted, criminals where capital punishment is legal."

Pro-lifers jumped on the idea, as The Sun reported. Giubilini and Minerva never indicated an age at which child-killing would be considered immoral. Could babies be offed at a month, six months, a year or more?

Would infanticide, relabeled after-birth abortion, lead to even more legal killings? "This slope has far more room left down which we could slide," Catholic Moral Theology writer Charles Camosy concluded.

Journal editor Julian Savulescu told The Telegraph the ethicist pair had received death threats. The two posted a somewhat side-straddling response in the JME blog on March 2. "We had no idea that our paper would raise such a heated debate," they wrote. "It was meant to be a pure exercise of logic: if X, then Y."

Could the two have played a devil's advocate, either inadvertently or intentionally, reigniting the age-old debate on when personhood begins?

"The Catholic Church has been making the same logical connections between abortion and infanticide for ... 2000 years," Camosy claimed in a post for Oxford University's Practical Ethics.

Giubilini and Minerva may have added ammunition to the pro-life camp by suggesting equality between the newly born and the unborn. Killing is either wrong or right. If life matters after birth, perhaps the ethical and medical communities will reexamine pre-birth existence.

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After-Birth Abortion Claim Points Instead to Pre-Birth Humanity