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Thread: Stemcellsinc is out ?!

  1. #1
    Senior Member lunasicc42's Avatar
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    Stemcellsinc is out ?!

    what the feezy!!?

    http://investor.stemcellsinc.com/pho...cle&ID=2173446

    Are they giving up ? This is crazy
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


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  2. #2
    Quote Originally Posted by lunasicc42 View Post
    what the feezy!!?

    http://investor.stemcellsinc.com/pho...cle&ID=2173446

    Are they giving up ? This is crazy
    I posted the link to the Globe Newswire and The Niche blog. LINK

    Perhaps another company will purchase the IP here and build on some of the earlier work. It appears to be much the same as when Geron was going under and was later picked up and purchased by Asterias which is running a sub-acute SCI clinical trial. The burn rate on these stem cell trials are extraordinarily high.
    Last edited by GRAMMY; 05-31-2016 at 01:08 PM.

  3. #3
    Grammy, I just finished watching the video of Michael Fehlings from your blog, "Repair and regeneration of the injured spinal cord: From Molecule to Man." After hearing about some things Dr. Fehlings said in that presentation, I'm very interested to learn more about the decision to cancel this trial based on "the magnitude of the effect and the perceived trend of the effect over time did not justify continuing the study or exploring the variability in the initial patient observations, given the financial resources available to the Company." I hope a report is made available somewhere about what the magnitude of the effects actually were, and I'm wondering if Dr. Fehlings was involved in this decision at all.

    In the presentation he gave which is linked in your blog, something he said struck a cord with me... "If the medical community wasn't going to accept the results of well-done, randomized control trials that had a small effect size because the effect sizes were small, we're dead in the water. We might as well try to stop advancing anything in the field of SCI...because the therapeutic effects we're going to witness are probably going to be small. It's unlikely any of us are going to come up with the silver bullet that's just going to be able to make all the phenotypic presentations vanish. Small differences matter." and a few minutes later... "When you're starting to ask questions like 'how important are these effect sizes, its one thing to ask a physician but it's another thing to actually ask someone who is in a wheelchair."

    I would hope that the effect sizes they were finding in this Phase II trial were so minuscule that nobody would find them significant, but I think that's unlikely given that in the article lunasicc42 posted, they stated that results showed "encouraging improvements".

    I would hope that something we can learn from this is the importance of investigating combinatory therapies and taking those combinations to trial. I realize we have to do things like test the safety of each individual component first. But what kind of effect sizes might we have seen from StemCells Inc cells if they had been combined with some other strategy that holds promise for inducing neuroplasticity or guiding/enhancing regeneration? We may now never know.

    I hope Steven Huhn is still planning on going to Working 2 Walk. I have lots of questions for him.

  4. #4
    The Company will attend the 14th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in San Francisco, California, on June 23. The Company will present Cohort I data from the Pathway Study and its interim analysis outcome. I'm sure we'll be reading a whole lot more also from Paul Knoepfler at the lab stem cell blog called "The Niche".

  5. #5
    Personally I didn't see this company going anywhere anyways, I imagine neural stem will follow behind. From early results from the phase 1 it seems that there were minor sensory improvements with some patientsbut it was all over the place very sporadic they also had no rehab component, Going into a phase IIb . I'm sad my country chose this company to put efforts towards!

  6. #6
    Quote Originally Posted by tomsonite View Post
    Grammy, I just finished watching the video of Michael Fehlings from your blog, "Repair and regeneration of the injured spinal cord: From Molecule to Man." After hearing about some things Dr. Fehlings said in that presentation, I'm very interested to learn more about the decision to cancel this trial based on "the magnitude of the effect and the perceived trend of the effect over time did not justify continuing the study or exploring the variability in the initial patient observations, given the financial resources available to the Company." I hope a report is made available somewhere about what the magnitude of the effects actually were, and I'm wondering if Dr. Fehlings was involved in this decision at all.

    In the presentation he gave which is linked in your blog, something he said struck a cord with me... "If the medical community wasn't going to accept the results of well-done, randomized control trials that had a small effect size because the effect sizes were small, we're dead in the water. We might as well try to stop advancing anything in the field of SCI...because the therapeutic effects we're going to witness are probably going to be small. It's unlikely any of us are going to come up with the silver bullet that's just going to be able to make all the phenotypic presentations vanish. Small differences matter." and a few minutes later... "When you're starting to ask questions like 'how important are these effect sizes, its one thing to ask a physician but it's another thing to actually ask someone who is in a wheelchair."

    I would hope that the effect sizes they were finding in this Phase II trial were so minuscule that nobody would find them significant, but I think that's unlikely given that in the article lunasicc42 posted, they stated that results showed "encouraging improvements".

    I would hope that something we can learn from this is the importance of investigating combinatory therapies and taking those combinations to trial. I realize we have to do things like test the safety of each individual component first. But what kind of effect sizes might we have seen from StemCells Inc cells if they had been combined with some other strategy that holds promise for inducing neuroplasticity or guiding/enhancing regeneration? We may now never know.

    I hope Steven Huhn is still planning on going to Working 2 Walk. I have lots of questions for him.
    Data on a slide shared with me today from a SCI conference showed CNS portfolios in big pharma (2009 -2014) dropped from 267 to 129. (A decline of more than 50%). Now the second failure of a small biotech investing in regenerative medicine for chronic SCI will help to scare off additional VC willing to take a stab at it. The barriers grow higher instead of being lowered. There's serious work in the field and community needing to be done. You're right in that it is important to investigate the size of effects that is expected and what will be considered a success. I think there's an awful lot of information that will have to be sorted out and regrouped on how the field must change in order to move forward with combination treatments. There's a ton of work to be done.

  7. #7
    Senior Member lunasicc42's Avatar
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    Grammy, which sci conference? Anything particularly interesting that you can share?
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  8. #8
    Senior Member PC720's Avatar
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    What I took from the press release was that it wasn't that it didn't work, it's just that it didn't work well enough. the injections they were doing were yeilding diminished returns. The test subjects were only getting slightly better. I too also expect neural stem to fold as well. I read somewhere that just recently the cells responsible for locomotion have either been discovered or we learned how to produce them. Something like that. im no stem cell scientist but If that's the case I fully expect even inVivo to fail. In any case science does have a long way to go. Unfortunately.

  9. #9
    Quote Originally Posted by PC720 View Post
    ... In any case science does have a long way to go. Unfortunately.
    Science has a long way to go, but not nearly as long of a way as the business, marketing, and economic aspects that will be necessary to make a cure happen. Science will keep on getting hampered by business decisions like this one.

  10. #10
    Subjects showed "encouraging patterns of improvements from baseline, especially in the first six months of the study." Did they participate in PT? If so, was it stopped at 6 months? If didn't participate, how much more substantial would their gains have been w/PT? Many questions to be answered. Seems as if they are bailing on this prematurely.

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