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  1. ChenPengFi is online now
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    11/28/2010 1:34pm

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    Quote Originally Posted by PointyShinyBurn View Post
    Be aware that though this procedure is probably safe there no good evidence (i.e. randomised controlled trials) for its efficacy and this company is currently doing a complex dance to avoid FDA regulation.
    Those take time and money.
    The clinic is very candid and publishes their data.
    The "dance" you refer to seems disingenuous as well when:
    Colorado Medical Clinic Welcomes Opportunity to Fight FDA in Court

    Clinic Claims FDA Has Repeatedly Overstepped Regulatory Authority

    DENVER, Aug. 9 /PRNewswire/ -- Regenerative Sciences, Inc., a Colorado medical practice that specializes in the use of a person's own stem cells to help patients avoid more invasive orthopedic surgery, announced today that the US Food and Drug Administration (FDA) is seeking to enjoin the clinic physicians from practicing medicine using patients' own stem cells. The lawsuit will allow Regenerative Sciences to question the FDA's policy that adult stem cells can be classified as drugs when used as part of a medical practice.
    "For two years we've been prodding the FDA to respond to our questions about how it has the ability to regulate a medical practice, so we're encouraged that, as a result of this recent suit, the courts will decide if it the FDA has regulatory authority over the adult stem cells that live in everyone's body," stated Centeno. "This is an important case for everyone that suffers from any type of illness, not just patients with orthopedic problems. It will decide, once and for all, if the government has the right to restrict a patient and their doctor from using a person's own stem cells to treat disease. Regenerative Sciences believes that stem cells are body parts and not the property of the government or big pharma."
    (my bold)
    http://www.prnewswire.com/news-relea...100247969.html
  2. PointyShinyBurn is offline
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    Posted On:
    11/28/2010 1:47pm

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    Quote Originally Posted by ChenPengFi View Post
    Those take time and money.
    The clinic is very candid and publishes their data.
    That's nice of them, but the data they've published doesn't prove anything about efficacy. They've been doing this for several years, it's surprising they don't have a proper RCT with even a small number of patients. The 'time and money' you spend doing it is what distinguishes real medicine from snake-oil.
    Quote Originally Posted by ChenPengFi View Post
    The "dance" you refer to seems disingenuous as well when:
    http://www.prnewswire.com/news-relea...100247969.html
    That's just PR, the reality of the situation is that they're trying to avoid being regulated by the FDA. It may be that they even win the case, I am not deeply au fait with US medical law, but that doesn't stop this being an experimental treatment at best and total quackery at worst.
  3. ChenPengFi is online now
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    Posted On:
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    Quote Originally Posted by PointyShinyBurn View Post
    That's nice of them, but the data they've published doesn't prove anything about efficacy.
    Data is only one part of that process.

    They've been doing this for several years, it's surprising they don't have a proper RCT with even a small number of patients.
    By what timeline are you operating under?
    Please elaborate, you seem to be contradicting yourself.
    A small number of patients over several years would lead to quick conclusions how?

    The 'time and money' you spend doing it is what distinguishes real medicine from snake-oil.
    Do we not agree that this is cutting edge tech?

    That's just PR, the reality of the situation is that they're trying to avoid being regulated by the FDA.
    As opposed to your unfounded allegations?
    Yes they are, did you read the quotes or the article i linked?
    The "dance" is addressed in the quote above...
    These are your cells, not a drug.

    It may be that they even win the case, I am not deeply au fait with US medical law, but that doesn't stop this being an experimental treatment at best and total quackery at worst.
    So more speculation and an argument from ignorance? Great...
    "At best" this could revolutionize medicine as we know it.
    It is IN FACT an "experimental" procedure.
    "Total quackery" is unlikely at this point.
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    Posted On:
    11/28/2010 2:26pm

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    Quote Originally Posted by ChenPengFi View Post
    By what timeline are you operating under?
    Please elaborate, you seem to be contradicting yourself.
    A small number of patients over several years would lead to quick conclusions how?
    Sorry, I don't understand what you mean? If they are genuinely seeing the enormous effect sizes they seem to suggest the even an n=20 or so size trial should provide some support for their ideas.

    According to their own site they've treated more than 450 people.
    Quote Originally Posted by ChenPengFi View Post
    Do we not agree that this is cutting edge tech?
    It is certainly novel. That doesn't mean you don't have to prove it works.
    Quote Originally Posted by ChenPengFi View Post
    As opposed to your unfounded allegations?
    Yes they are, did you read the quotes or the article i linked?
    The "dance" is addressed in the quote above...
    What unfounded allegations? By 'dance' I meant the legal proceedings they are, in fact, going through. Whatever horribly pejorative meaning meaning you've read into it was not my intention.
    Quote Originally Posted by ChenPengFi View Post
    So more speculation and an argument from ignorance? Great...
    What speculation, precisely?
    Quote Originally Posted by ChenPengFi View Post
    "At best" this could revolutionize medicine as we know it.
    It is IN FACT an "experimental" procedure.
    OK, that's true of any suggested procedure.

    Homeopathy or faith healing will look like they works if you survey the patients after the treatment and ask them if they feel better, which is why science is not done that way.
    Quote Originally Posted by ChenPengFi View Post
    "Total quackery" is unlikely at this point.
    Why do you think that? Without speculating on their motives, they might well think it works and be wrong.
  5. ChenPengFi is online now
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    Posted On:
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    Quote Originally Posted by PointyShinyBurn View Post
    Sorry, I don't understand what you mean? If they are genuinely seeing the enormous effect sizes they seem to suggest the even an n=20 or so size trial should provide some support for their ideas.

    According to their own site they've treated more than 450 people.

    Ah, ok. That makes more sense and fair enough.
    Not sure, but from the literature i gather that they are not really interested in kowtowing to the FDA at this point because of the landmark nature of this case.
    Further they seem unwilling to do so prematurely, after all your proposed study could just as easily be dismissed due to the small sample.


    It is certainly novel. That doesn't mean you don't have to prove it works.
    Never implied otherwise.
    What unfounded allegations? By 'dance' I meant the legal proceedings they are, in fact, going through. Whatever horribly pejorative meaning meaning you've read into it was not my intention.
    The "dance' seems to imply something shady, i retract if that was not your intention.
    "Avoiding" is not the same as questioning the right of the agency iin question.
    On the contrary i think they are doing a good thing by questioning these
    What speculation, precisely?
    "It may be..." for one...

    OK, that's true of any suggested procedure. Homeopathy or faith healing will look like they works if you survey the patients after the treatment and ask them if they feel better, which is why science is not done that way.
    More speculation or outright BS.
    Do you really think that they are relying on the subjective measures that you describe, despite all of the MRIs they publish?
    How is asking if someone feels better even relevant here?
    No, there is ample evidence that this is a valid procedure, unlike homeopathy.
    We know what stem cells do, roughly.
    We can measure cartilage growth.
    If after a procedure, and nothing else has changed, how else would you explain marked objective improvement?


    Why do you think that? Without speculating on their motives, they might well think it works and be wrong.
    Because the reasoning is sound.
    How do you explain the client i had then?
  6. PointyShinyBurn is offline
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    Posted On:
    11/28/2010 3:18pm

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    Quote Originally Posted by ChenPengFi View Post
    Not sure, but from the literature i gather that they are not really interested in kowtowing to the FDA at this point because of the landmark nature of this case.
    This wouldn't be a question of kowtowing to anything other than the scientific method. Even with such a study the FDA would still be against the therapy until it had been through proper three-phase clinical trials. I'm not sure why it being 'landmark' changes anything here, if anything they should be more anxious to prove their case.
    Quote Originally Posted by ChenPengFi View Post
    Further they seem unwilling to do so prematurely, after all your proposed study could just as easily be dismissed due to the small sample.
    It would be at least suggestive, and likely get them investment for larger trials. It's certainly not premature to do this kind of thing given that they are already treating patients and charging money, it's actually unacceptably late to be starting on any generally accepted medical model.

    Quote Originally Posted by ChenPengFi View Post
    More speculation or outright BS.
    Do you really think that they are relying on the subjective measures that you describe, despite all of the MRIs they publish?
    I don't know how to read those MRIs and neither, I would guess, do you. But the only quantified data I can find on their site is what percentage of patients say they have better movement.

    Quote Originally Posted by ChenPengFi View Post
    Because the reasoning is sound.
    In a general, hand-wavey kind of way. Yes, stem cells can turn into stuff. The specifics of their proposed mechanism aren't really explained.
    Quote Originally Posted by ChenPengFi View Post
    How do you explain the client i had then?
    I don't know the guy, so it's hard to speculate, but (assuming the procedure doesn't actually work, note I'm not saying it certainly doesn't) placebo is one possibility.
    Last edited by PointyShinyBurn; 11/28/2010 3:21pm at .
  7. KiwiPhil889 is offline

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    Posted On:
    11/28/2010 3:56pm


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    Personally i think this type of technology is awesome. Not yet fully understood or applied but awesome none-the-less. Have heard of a few examples of stem cells being injected into problem areas with some pretty amazing results. People taking back ground on things like Alzheimers kinda amazing.

    As for understanding the process??. They can already deliberately produce spinal cord material from stem cells, heart valve (?i think), and can take an adults tissue and strip away all of the extra bits to reduce it back to what is essentially the equivalent of infant stem cell material, so the tech is kinda understood (reverse engineering anyone? lol). Its the building it back up into the specific thing you want that still has alot of room for growth,but they are already doing it for limited items in the body.
  8. PointyShinyBurn is offline
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    Posted On:
    11/28/2010 4:15pm

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    Quote Originally Posted by KiwiPhil889 View Post
    As for understanding the process??. They can already deliberately produce spinal cord material from stem cells, heart valve (?i think), and can take an adults tissue and strip away all of the extra bits to reduce it back to what is essentially the equivalent of infant stem cell material, so the tech is kinda understood (reverse engineering anyone? lol). Its the building it back up into the specific thing you want that still has alot of room for growth,but they are already doing it for limited items in the body.
    You're talking about induced pluripotency. Regenexx aren't doing that, they're just pulling bone marrow stem cells and injecting them into the joint with some growth factors.
    Last edited by PointyShinyBurn; 11/28/2010 4:18pm at .
  9. ChenPengFi is online now
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    Posted On:
    11/28/2010 4:30pm

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    Nice cherry picking PSB.
    You're all over the place man...
    Subjective vs objective, speculation, argument from ignorance, poisoning the well etc etc...
    WTF, you just having fun or am i supposed to be buying this bs?
    So because you can't read an MRI they are invalidated?
    Please...
    BTW, there is such a thing as a clinical approach to research...
  10. PointyShinyBurn is offline
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    Posted On:
    11/28/2010 4:38pm

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    Quote Originally Posted by ChenPengFi View Post
    So because you can't read an MRI they are invalidated?
    No, because they haven't had them graded in a quantified way and published it in a peer reviewed journal. Just collecting them, or posting them, doesn't prove anything. They need to have a blinded grading done with a proper control group if they want to demonstrate something.
    Quote Originally Posted by ChenPengFi View Post
    BTW, there is such a thing as a clinical approach to research...
    There is, it pays my wages. What they are doing is not it. You start with a small randomised trial first, you don't treat nearly 500 people and have a multi-channel marketing blitz before thinking to find out if your therapy actually works or not.

    What they are doing is cowboy stuff. You might not mind, but if people choose to sign up for this they need to know what they are getting into.
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