Wednesday, February 18, 2009

Dangers with Embryonic Stem Cell Clinical Trials



Here is a picture of a teratoma, a type of germ cell tumor, which has often been found associated with the use of embryonic stem cells in animal studies. These teratomas can contain mature processes such as limbs, hair, muscle and bone.

Today a story in Nature News provides an article entitled "Tumours spark stem cell review". In the Nature News article, they discover that a young boy who had received treatments of fetal neural stem cells for a neurodegernerative disease (ataxia telangiectasia) in Moscow was found riddled with tumors in his brain and spinal cord. The tumors came from his fetal neural stem cell treatment.
These types of dangers from embyronic stem cell treatments are widely known within the scientific community, but often are not discussed. Persons entering into future clinical trials with embryonic stem cells should understand the risks invovled. They are substantial.

22 comments:

  1. People don't think of cells from embryos as dangerous--but look how much they are. I think it has so much to do with the arrogance and greed of medical researchers, trying to play God.

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  2. People don’t think of cells from embryos as dangerous because scientists keep the dangers quiet…away from the public’s ear. Anyone that has studied embryonic stem cells knows for a fact that these cells and the current research and future clinical trials hold dangerous perspectives. They also know embryonic stem cells hold little hope for use as a therapeutic cure due to the limitations of epigenetic factors which regulate differentiation. But the scientific communality keep the dangers and the limitations of the research quiet in order to lure desperate patients as experimental guinea pigs and as an excuse to use the human embryo for other scientific exploitations …one of which is a tool for bio-warfare research.

    The ethics within the embryonic stem cell community have become appalling, using the media, political ties and unethical legal maneuvers to squash any claims against them. For example, scientists who raise bioethical or safety concerns within the embryonic stem cell research community can and have been fired with no recourse. There are no laws to protect these scientists and, therefore, no laws to protect public health and safety.

    The embryonic stem cell community does not care about embryonic life issues or public health and safety or scientist’s right’s. They care about "advancing science" at any cost. And one of the costs is the dehumanization of the embryo and thus a loss of human rights. It is a loss which will have dramatic effects for the future.

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  3. all i know is that picture looks nasty.

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  4. That would happen in moscow...
    But you guys think that medical researchers are evil! Hahaha how mistaken you are. They just want better ways to cure disease. People who receive these experimental treatments are informed of the dangers and participate at their own risk. They're usually the ones who would die due to lack of established treatments anyway. To say that the researchers are evil is a pretty warped view.

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  5. Jesus! Are there any scientists associated with this "watchdog on science" site? Is this site actually hiding an evangelical, antiscience bias? Just curious that no one is ranting about how fascintating this diagnosis is (even when there is no history of stem cell involvement!). Perhaps I have misunderstood . . . Do forgive. Anna

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  6. Dear Anna,

    Yes you have misunderstood. It is a documented scientific fact that embryonic stem trials in animals often lead to developments of teratomas. So it was not surprising to many embryonic stem cell scientists that after this young boy received an embryonic stem cell treatment, teratomas were found. Unfortunately, teratoma development is one of the dangers of using embryonic stem cells for clinical applications.

    The reason being is that in natural embryonic development of the egg within the womb, embryonic stem cells are guided by positional, epigenetic, and genetic effects from a community of cells as the embryo divides. Signals from this complex community of dividing cells provide necessary biological directions to neighboring cells for proper differentiation and proper placement of cells within the embryo. Without these signals from neighboring cells, the embryo will not form properly.

    Today scientists are trying to take an embryonic stem cell out of its natural environment and artificially force its differentiation in a petri dish to make heart, muscle, neurons or any variety of cells. This unfortunatley is a complex scientific task and a dangerous one. When an embryonic stem cell is used outside its “normal” developmental environment and instead is placed in an artificial experimental environment to force differentiation outside this community of cells, many developmental signals are missing which subsequently, misdirects the development and differentiation of the embryonic stem cell, leading to the formation of a teratoma. A teratoma is an embryo like tumor which has obviously tried to differentiate into an embryo but without proper directions to do so. Teratoma formation is a fact, not an evangelical anti-science statement.

    To my knowledge, there are no evangelical antisicence bias or hidden agendas on this website. Rather this blogsite is devoted to discuss human rights issues and human dignity issues in relationship to science, public policy and public health and safety. The writings from several authors on this website point toward educating the public and protecting the public against unethical clinical trials and dangers associated with technologies that can cause public health and safety threats.

    For more on public health and safety issues related to embryonic stem cell research see this video link: http://blip.tv/file/2061380.

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  7. Your reporting of events is riddled with bias.

    Please try to remain more neutral-- the pitfalls and benefits of stem cell research as of yet. I would have listened to your story more if you weren't so clearly against embryonic stem cell research.

    e.g. the benefits of the stem cells on the boy's ataxia telangiectasia.

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  8. Dear Anonymous,

    The story is not riddled with bias. This story was reported in national newspapers.

    I am not against embryonic stem cell research. But I do believe that the public has a right to understand the dangers associated with embryonic stem cell research. I also believe that this industry should and MUST be regulated with effective OVERSIGHT since it not only has ethical concerns but safety concerns that are tied to public health and safety threats.

    Dangerous research is part of the development of embryonic stem cell technologies. Clinical trials in using these technologies are also extremely dangerous.

    It is the scientific community who are being biased...promising the lame to walk and the blind to see...but unbelievably not mentioning the dangers associatted with both the clinical trials and the research to develop these technologies.

    The scientific community engaged in hype to sell embryonic stem cell research in order to use human embryos for researach. Now that they sold the public on the hype and biasness...now they have to convince the public that the lame and the blind will have to remain that way for quite some time...something they knew all along.

    Don't talk to me about hype and biasness. Talk to me about the truth.

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  9. Science may be dangerous, but what human endeavor is not? Through trial and error, we learn. Some people may have to bite the bullet right now, but the more we learn and the faster we learn it about stem cell research, the more it will benefit those in the future.

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  10. Dear Anonymous,

    Better to "bite the bullet" with full understanding of the dangers of ESC technologies and full consent rather than how it is being done presently. It is a shame that the embryonic stem cell community plays a hidden hand by obfuscating the dangers associated with this technology and not being responsible for worker safety or public health and safety.

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  11. Watchdog says: "The story is not riddled with bias. This story was reported in national newspapers." Just because the story was reported in national newspapers doesn't mean your summary of the article/comments don't contain a bias.

    If you read the original article from Nature News it says: "'This is the first documented case of tumours resulting from fetal-cell transplant,' says Wise Young, a neurosurgeon at Rutgers University in Piscataway, New Jersey." I don't think you can classify one incident as "often."

    Clinical trials and research has risks, that's why they're still in the beginning stages. And like the bioethicist says "People who undergo these cell-based therapies have a responsibility to share any adverse events that happen."

    Who exactly is this industry that "MUST be regulated with effective OVERSIGHT" that you talk of? Is the United States supposed to police all stem cell research? There are regulations here but it doesn't extend to everyone.

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  12. I don't see anywhere in the Nature News article or research journal article cited (http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000029) that describes the tumors as teratomas. But I guess it makes for a good picture. In the medical journal the tumors are described as a glioneuronal neoplasm.

    The problem with relying on wikipedia, google, blogs and even newspapers is the information is not always reliable. Do your research and trust credited, evidence based sources where the infomation is provided in an unbiased, educated way. It may be harder to read but sometimes it is a whole lot more accurate.

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  13. Dear Laura L,

    You ask a very good question when you wonder exactly WHO in this industry must be regulated with effective oversight. It carries a complex answer. Perhaps we can look at it in broader terms right now:
    1. The first would be to strengthen scientist’s rights to free speech and their ability at all levels to participate in proper safety oversight. Surprisingly, scientists do not have effective laws to protect them against adverse effects for their freedom of speech regarding safety or bioethical concerns. These important rights are relevant for public transparency and for public health and safety. In fact, scientists do not even have the right to obtain exposure records for healthcare from dangerous biological exposures incurred at work since “trade secrets” supersede their rights. This of course is a political maneuver to protect corporate and academic interests over public interests. It also is an unethical way to make biotech and embryonic stem cell research “appear” safer than it really is. The public should be alarmed at the glaring legal deficiencies to protect scientists, as well as, to ensure public health and safety.
    2. The second would be that all research entities (private and academia researchers) who wish to work on human embryos and human embryonic stem cells for basic or clinical research should be mandated to be registered with the federal government.
    3. Thirdly, we need government oversight on all academic and private groups using human embryos and the associated dangerous genetic technologies to document the “who, what, where and why” of human embryonic stem cell experimentation to ensure biosafety and bioethical compliance.
    4. Fourthly, we must increased public transparency with FOIA (Freedom of Information Act) so that information regarding any use of human embryos or human embryonic stem cells is available to journalists and the public, the only effective watchdog groups we have.
    5. Lastly, severe criminal penalties including jail time must be imposed on scientists and institutions that are in non-compliance with biosafety and bioethical laws.

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  14. Dear Laura L,

    Since we have had limited clinical data on human experimentation with human embryonic stem cells, this one documented incident confirms what the historical animal data proves: that embryonic stem cell treatments can cause tumors, cancers and teratomas.

    Most importantly, the fact remains that teratomas are often an undesirable byproduct found in experimental animals that have undergone embryonic stem cell treatments. This is a documented and well known fact within the embryonic stem cell community. It is a serious concern for any patient who might be considering entering into an embryonic stem cell clinical trial.

    Here are some references on teratomas and embryonic stem cells for your review:

    http://www.ncbi.nlm.nih.gov/pubmed/18393673

    http://www.cell.com/cell-stem-cell/fulltext/S1934-5909(07)00086-0

    Teratomas from pluripotent stem cells: A clinical hurdle.
    http://www.ncbi.nlm.nih.gov/pubmed/20665544

    Lastly…..

    Dr. Jonathan d. Moreno (who is a celebrated ADVOCATE for human embryonic stem cell research writes about the upcoming Geron human embryonic stem cell trial: “The greatest concern that experts have about the trial is that potent cells injected into the spine might develop into tumors called teratomas. This worry explains the FDA’s cautious approach. ... By contrast, owing to the potential harm, novelty, and public controversy, the Geron trial is surely among the most intensively reviewed proposed clinical trials in history.”
    http://www.scienceprogress.org/2010/08/one-small-step-for-embryonic-stem-cells/

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  15. Good ideas on regulation of stem cell research and therapy but the laws/regulations, FDA, federal goverment, and the FOIA only apply in the US. What do you do when the boy who prompted the hoopla in the first place is in Moscow?

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  16. Over-proliferation of stem cells can cause cancer but the under-proliferation of stem cells leads to tissue dystrophy, anemia, immuno-deficiency, or infertility. His lab has identified class of small RNAs called piRNAs and investigates their role in regulating human embryonic stem cell division and in causing cancer.

    http://opa.yale.edu/news/article.aspx?id=7674

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  17. This comment has been removed by a blog administrator.

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  18. Dear Medexpressrx,

    Where are you getting information that stem cells PROMISE to regenerate organs? You are misinformed. There are no promises anywhere.

    You speak of stem cell potential this and stem cell potential that. Where are the cures that scientists have promised from embryonic stem cells?

    Promises run cheap while the dangers from embryonic stem cells remain hidden within the scientific community.

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  19. Yes, the moment is historic but for now, the trial is just a safety-test and the injection held the lowest dose of the stem cell concoction possible. Also, only the most severely injured patients are eligible. Today’s patient—whom Geron has kept anonymous—suffered a “thoracic spinal cord injury” which means he or she is a paraplegic with no movement below the chest.

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  20. There are dangers with every treatment. There are side effect of every drug.

    why is it that when stem cell is still in it's research state people are attacking it?

    Also when people say the dangers are hidden but they are not. If you do even a few minutes worth of research you can understand the dangers.

    Also god should be left out of discussion as there will never be a winner in the argument.

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  21. Teratomas are not just associated with stem cells either as this article seems to imply. These actually occur 'naturally' in some people, I have seen many in just one year working in an E.R.

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  22. Great knowledge that you have shared. I think very few might be knowing about this...

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