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Thread: Medical ethics with stem cells

  1. #1 Medical ethics with stem cells 
    Forum Radioactive Isotope skeptic's Avatar
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    This comes from an article in New Scientist, 10 August page 43.

    Stem cell treatments are now on offer in many places round the world. Yet trials are incomplete, and development is ongoing. Results so far are variable, with many treatments seen to be ineffective. The legal and ethical situation is unclear.

    In the USA, the FDA treats stem cells like unproven drugs. When stem cells are taken from a person's own body and reinjected immediately, the FDA has no problem. But when the same stem cells are removed, processed in a laboratory to multiply their number, and the increased number of cells reinjected, the FDA bans it, saying this falls under the same regulations as unapproved drugs.

    Advocates for the freedom to use stem cell therapies, even if unproven, state that those stem cells are from their own body, and they should have the right to say what is done with them.

    Should the FDA be doing ths? Is this ethical, logical or rational? With their own stem cells, should a patient have the right to determine how they are used?


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    If the patient donates its stem cells, in order to inject them into the body of the patient after they were modified,
    then I think that patients have indeed the right to determine their use.


    Last edited by Cogito Ergo Sum; August 18th, 2013 at 06:02 PM. Reason: Misunderstanding of OP.
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  4. #3  
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    The FDA is notorious for meddling and attempting to regulate and control as much as it possibly can- to the point of dishonesty.

    "Spin" applies, here- the FDA will test a product and declare it "unsafe" and needing of further testing and regulation if they detect such and such chemicals but they deliberately neglect to disclose that they detected it in such trace amounts that it's actually less than what you breathe in standing outside.
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  5. #4  
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    Cog, i think you missed skeptic's point it is about the right th use one' own processed stem cells in one's own body.

    (unless, of course I misunderstood skeptic's point)

    And, yes, i do think that that should be the patient's choice.

    sometimes, the fda seems a rather odd bureaucracy
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  6. #5  
    Forum Ph.D. Nevyn's Avatar
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    I guess that one of the bigger issues is the unproven safety of these cells, lets not forget that they have the potential to gone on a proliferative rampage. Cells outside the body are notoriously hard to keep happy and cellular stress increases the likelyhood of mutations.

    A recent nature world view article (18/07/2013, vol 499 p255) quite succinctly put forward the point that many companies have sprang up marketting mesenchymal stem cells for a applications that currently go against wide stream scientific evidence.

    I personally believe that potential therapies shouldn't get to far ahead of themselves, this has been seen before with the thalidomide case as a prime example. It would be a shame to see a therapy taken off the market due to the actions of a few companies trying to make money and in the end the safety of the patient is one of the key issues.
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  7. #6  
    Forum Radioactive Isotope skeptic's Avatar
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    To Nevyn

    I do not consider myself an 'expert' here, but the article had some good information. Among other things, it said that over 1,000 people have had multiplied stem cells injected back into their bodies without problems. That seems to me to be a good indicator of relative safety?
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  8. #7  
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    Quote Originally Posted by skeptic View Post
    they should have the right to say what is done with them.

    Should the FDA be doing ths? Is this ethical, logical or rational? With their own stem cells, should a patient have the right to determine how they are used?
    This again boils down to "criminal activity" involving no victim. Just like injecting heroin. It's MY body, and only GOD has the right to limit what I do to it! Peeling away all it's layers of wonderful intent, the FDA is simply another stinking bureaucracy, focussed on the never-ending quest for more parasitic revenue, as Neverfly points out. Just MHO, not very humble, is it?


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  9. #8  
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    no,
    but, I like it
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  10. #9  
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    Quote Originally Posted by skeptic View Post
    To Nevyn

    I do not consider myself an 'expert' here, but the article had some good information. Among other things, it said that over 1,000 people have had multiplied stem cells injected back into their bodies without problems. That seems to me to be a good indicator of relative safety?
    This is the worldview article: Don

    I think that one of the main issues is that they are "unapproved" you can't have one rule for one section and a seperate one for another catogorywithout it being thoroughly justifyable. In this case I am not sure that it is, and if it truly is why can't it go through the same approval process? One of the main issues with these cells is the chance that they can cause cancer, you are essentially introducing into the body a type of cell that can be (nearly) anything and hasn't acheived its final state and so could replicate a lot. I think the long term impact hasn't yet properly been assessed.

    I think as a potential therapy for a lot of diseases they are of a lot of hope, however we have seen this before with such things as the magic bullet use of bacteriophage viruses to attack bacterial infections.

    for a treatment to become available it has to undergo two phase III clinical trials, this means that it has already been through:
    Preclinical trials: test toxicity in animals
    Phase 0: test how the treatment moves around the body in sub-therapeutic levels, typically 10 patients, is it removed from the body quickly?
    Phase I: test dosing requirements over a range, typically 10-100 patients
    Phase II: therapeutic dose testing with 100-300 patients, tests efficasy
    Phase III: same as II, but with a larger group, 1000-3000
    Phase IV: post-introduction monitoring

    To my own knowledge know treatments have yet gotten past phase III, a quick google didn't return anything other than a few trials that were entering phase III this year. As for specifically a patient derived stem cell treatment, the worlds first clinical trial trial was approved earlier this year: Japan govt approves stem cell clinical trials
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  11. #10  
    Forum Radioactive Isotope skeptic's Avatar
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    The article says South Korea has approved it as a full scale treatment for certain conditions. South Korea is a modern sophisticated nation with good medical standards.
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  12. #11  
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    South Korea is currently recovering from a massive scandel surrounding its stem cell research, in 2006 one of their prime scientists in the field was shown to have falsefied an article stating that he'd managed to create a stem cell from cloning. Up untill 2011 the country was investing little into stem cell research so it is possible that the country is trying to fast-track treatments to the market to try to regain its status. Also the treatments offered by south korea (Hearticellgram-AMI) is currently going through phase III clinical trials. There is always a danger in marketting a treatment before proper peer reviewed evidence is produced. The FDA will be trying to protect itself after all, who will be blamed if a treatment is fast-tracked to market at proves to be dangerous?

    with a bit more poking around it turns out that stem cell products are a bit further along than I thought, the FDA approved haemacord a month or so ago and announced a clinical trial for a drug for MS FDA Approves Stem Cell Clinical Trial For Multiple Sclerosis - Yahoo! Finance
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    Quote Originally Posted by skeptic View Post
    In the USA, the FDA treats stem cells like unproven drugs. When stem cells are taken from a person's own body and reinjected immediately, the FDA has no problem. But when the same stem cells are removed, processed in a laboratory to multiply their number, and the increased number of cells reinjected, the FDA bans it, saying this falls under the same regulations as unapproved drugs.
    That makes sense. It would be trivial to induce uncontrolled division in cells removed from the body (i.e. cancer.) Reinjecting them would then result in cancer spreading throughout a patient's body. That would seem like a bad idea.

    Stem cell therapies show a lot of promise but they are still in their infancy.
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  14. #13  
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    As I understand it, billvon, from the article, reinjecting multiplied stem cells has not caused any increased cancer risk.
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    Quote Originally Posted by skeptic View Post
    As I understand it, billvon, from the article, reinjecting multiplied stem cells has not caused any increased cancer risk.
    There's a lot of research currently going on into the potential for stem cells to cause cancer. Indeed, the stem cell theory of cancer indicates that stem cells are pretty ideal in terms of creating cancer; they are, after all, the cells that begin division into several other forms of cells, and overproduction of (say) pancreas cells is effectively pancreatic cancer.

    ===============
    The Stem Cell Theory of Cancer
    Stanford School of Medicine

    Research has shown that cancer cells are not all the same. Within a malignant tumor or among the circulating cancerous cells of a leukemia, there can be a variety of types of cells. The stem cell theory of cancer proposes that among all cancerous cells, a few act as stem cells that reproduce themselves and sustain the cancer, much like normal stem cells normally renew and sustain our organs and tissues. In this view, cancer cells that are not stem cells can cause problems, but they cannot sustain an attack on our bodies over the long term.
    The idea that cancer is primarily driven by a smaller population of stem cells has important implications. For instance, many new anti-cancer therapies are evaluated based on their ability to shrink tumors, but if the therapies are not killing the cancer stem cells, the tumor will soon grow back (often with a vexing resistance to the previously used therapy). An analogy would be a weeding technique that is evaluated based on how low it can chop the weed stalks—but no matter how low the weeks are cut, if the roots aren’t taken out, the weeds will just grow back.
    Another important implication is that it is the cancer stem cells that give rise to metastases (when cancer travels from one part of the body to another) and can also act as a reservoir of cancer cells that may cause a relapse after surgery, radiation or chemotherapy has eliminated all observable signs of a cancer.

    . . .

    The theory, therefore, is that cancer stem cells arise out of normal stem cells or the precursor cells that normal stem cells produce.
    Last edited by billvon; August 19th, 2013 at 04:37 PM. Reason: Added reference article
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  16. #15  
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    To bilvon

    That may be correct, but it is generally considered that cancer starts with a genetic change. Obviously, if you took a stem cell with a cancer causing genetic change, and multiplied it, and reinjected it, that would prove disastrous. But that does not seem to be happening. As long as the stem cells being multiplied are normal healthy cells, they should not contribute to cancer. I am not sure whether there is any way of testing stem cells to ensure that they are normal, but so far, the reinjections do not seem to have caused cancer.
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  17. #16  
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    Quote Originally Posted by skeptic View Post
    That may be correct, but it is generally considered that cancer starts with a genetic change. Obviously, if you took a stem cell with a cancer causing genetic change, and multiplied it, and reinjected it, that would prove disastrous.
    Right, and that's the problem. Cells reproduce up to a certain limit then stop; that's how your body normally works, and that's why you don't get cancer instantly. If you take cells out and just reinject them, no problem. If you try to force them to reproduce past their normal limits (of which there are several) you have to disable that limit so they can continue dividing.

    Will they stop multiplying again once reinjected? That's the gamble.

    But that does not seem to be happening.
    Well, it's happened at least once. (With stem cells but not autologous stem cells.)

    As long as the stem cells being multiplied are normal healthy cells, they should not contribute to cancer.
    Agreed. But normal healty cells don't reproduce in a significant way in a petri dish. You have to alter the environment they are in, which of course alters them. Which is why it's OK to reinject normal healthy cells, but not cells that have been modified in a lab.
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  18. #17  
    Forum Radioactive Isotope skeptic's Avatar
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    I am not sure that multiplying stem cells can be seen as the same as modifying them.
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    >I am not sure that multiplying stem cells can be seen as the same as modifying them.

    ?? But cancer cells are just regular cells that multiply. The only difference between them and "regular" cells is that they don't stop when they are supposed to. So if you induce some cells to grow when they are not supposed to - it's going to be tough to ensure they won't grow when they are not supposed to.
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  20. #19  
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    If it is used for your treatment and they are your cells, what is the issue? I agree with you, Corgito Urgo Sum
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  21. #20  
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    Bilvon

    Stem cells are not cancer cells. A cancer cell has to have a genetic change to make it grow uncontrollably. Stem cells do not have that change, and do not behave that way.

    Well, with the wrong mutation they might. But that is not normally the case, and experience shows that if it happens, it is rare.
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    Quote Originally Posted by babe View Post
    If it is used for your treatment and they are your cells, what is the issue?
    Cancer cells are your own cells, but they are still an issue.
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  23. #22  
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    Quote Originally Posted by skeptic View Post
    Stem cells are not cancer cells. A cancer cell has to have a genetic change to make it grow uncontrollably. Stem cells do not have that change, and do not behave that way.
    Right. But you are removing those cells and forcing them to grow more than they would normally. Will they shut down again when they are supposed to? That's the problem.

    Well, with the wrong mutation they might. But that is not normally the case, and experience shows that if it happens, it is rare.
    Once we prove that we might see more approvals of autologous cell modification treatments.
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    Well I've just been diagnosed with leukemia, and will require bone marrow transplants. But the way it's done now is that rather than removing the marrow from a donor, growing it and then injecting it into me, they administer a growth hormone to the donor with stimulates the creation of stem cells. They siphon off the stem cells, culture them, and inject them into my marrow. A much faster, safer, and far more painless procedure, both for the donor and for me.

    Yeah stem cells!
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    Alex it takes real guts to be able to share something like that, respect, I share the same sentiments as PhDemon and really hope everything works out ok, you have my best wishes towards a swift and successful recovery.
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  26. #25  
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    Quote Originally Posted by Ascended View Post
    Alex it takes real guts to be able to share something like that, respect, I share the same sentiments as PhDemon and really hope everything works out ok, you have my best wishes towards a swift and successful recovery.
    Thanks.

    It's not something I'd usually say anything about, but it's pertinent to the subject, so what the hell.
    Its the way nature is!
    If you dont like it, go somewhere else....
    To another universe, where the rules are simpler
    Philosophically more pleasing, more psychologically easy
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  27. #26  
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    Quote Originally Posted by AlexG View Post
    Well I've just been diagnosed with leukemia, and will require bone marrow transplants. But the way it's done now is that rather than removing the marrow from a donor, growing it and then injecting it into me, they administer a growth hormone to the donor with stimulates the creation of stem cells. They siphon off the stem cells, culture them, and inject them into my marrow. A much faster, safer, and far more painless procedure, both for the donor and for me.

    Yeah stem cells!
    Oh my!! AlexG I am sooooo sooooo sorry to hear that!!

    I wish, with all my heart, that you will be fine!

    I know you all will laugh at this...but, I don't care....I'm sending you good karma from the heart!

    Please be well!
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  28. #27  
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    Quote Originally Posted by AlexG View Post
    Well I've just been diagnosed with leukemia
    Kick its butt.
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