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Thread: Neuralstem chronic sci

  1. #1

    Neuralstem chronic sci

    http://www.spinalcordinjury-paralysi...-chronic-trial


    I know its rats again. But ALS patient showed improvement. These cells seem POWERFUL!!! Thoughts? Summer trial starts!

  2. #2
    It's worth noting in the article Paolo posts here http://sci.rutgers.edu/forum/forumdisplay.php?f=32 that it's said that the authors of the article (Tuszynski and others) that Neuralstem is touting in moving towards clinical trial actually OPPOSE the decision to move to trial and feel that doing so may jeapordize the therapy if it proves ineffective. They feel that they need to look at more relevant injury models (blunt injury as opposed to transection and even more chronic time points) and note that the proposed trial doesn't include the fibrin growth matrix nor the growth factor cocktail that were a part of their intervention.
    I'd love for someone at U2FP or anyone who attends W2W to ask Richard Garr how they can appeal to the work of these scientists and at the same time ignore their concerns about testing the therapy in humans.

  3. #3
    This open-label, multi-site study will enroll up to eight patients with thoracic spinal cord injuries (T2-T12) who have an American Spinal Injury Association AIS-A level of impairment, between one and two years post injury. These patients exhibit no motor or sensory function in the relevant segments at and below the injury, and are considered to be in complete paralysis. Study patients will receive six injections in, or around, the injury site: the first four patients will receive 100,000 cells per injection; the second four patients, 200,000 cells per injection. All NSI-566 SCI patients will receive post-surgery physical therapy, as well as immunosuppressive therapy, which will be for three months, as tolerated. The trial study period will end six months post-surgery for each patient.

    Johe thinks his stem cells are versatile and robust enough to make a difference in both acute and chronic SCI, stroke, even brain cancer. Stem cells, he said, are not like drugs, which might target a specific process or action. “Stem cells are more like a shotgun – they offer many possible actions and mechanisms. A plethora of effects will be required for a reconstructive treatment in the spinal cord.”


    The primary objective of the study is to determine the safety and toxicity of NSI-566 for the treatment of paralysis and related symptoms due to SCI.
    The secondary objectives are to evaluate graft survival in the transplant site by MRI, as well as the effectiveness of transient immunosuppression.

    I don't know that proof of efficacy is being considered at this point according to their statements. However, the scientists working with the cells know that the best and true efficacy in the long run will have to be a "combination" to go along with the cell treatment. They're looking ahead at what additional measures will ultimately be required to have a blockbuster therapy for sci. That research still needs to be done. The FDA requires each piece of a combo therapy to be tested separately.
    Last edited by GRAMMY; 06-22-2013 at 06:33 PM.

  4. #4
    Quote Originally Posted by ay2012 View Post
    It's worth noting in the article Paolo posts here http://sci.rutgers.edu/forum/forumdisplay.php?f=32 that it's said that the authors of the article (Tuszynski and others) that Neuralstem is touting in moving towards clinical trial actually OPPOSE the decision to move to trial and feel that doing so may jeapordize the therapy if it proves ineffective. They feel that they need to look at more relevant injury models (blunt injury as opposed to transection and even more chronic time points) and note that the proposed trial doesn't include the fibrin growth matrix nor the growth factor cocktail that were a part of their intervention.
    I'd love for someone at U2FP or anyone who attends W2W to ask Richard Garr how they can appeal to the work of these scientists and at the same time ignore their concerns about testing the therapy in humans.
    Mark Tuszynski is one of the more conservative researchers out there with regards to achieving functional recovery in a chronic injury. Even he admits that had it not been for Paul Lu, who works for him in his lab, they would not have been undertaking the study with neural stems cells+growth factor matrix. However, he has been won over by Paul's work.

    NeuralStem's projected core revenues will be the sale of their technology - their line of stem cells for as many indications as possible. So for them, their short to medium-term success is likely to be measured by proving safety and some modest efficacy.

    NeuralStem will likely donate some of their cells to and perhaps even part-fund some of the translation work of labs like Tuszynski's to reap the benefits of greater efficacy in animal models using their technology not to mention the positive press for their stock prices.

    Business is business.

  5. #5
    Quote Originally Posted by Fly_Pelican_Fly View Post
    Mark Tuszynski is one of the more conservative researchers out there with regards to achieving functional recovery in a chronic injury. Even he admits that had it not been for Paul Lu, who works for him in his lab, they would not have been undertaking the study with neural stems cells+growth factor matrix. However, he has been won over by Paul's work.

    NeuralStem's projected core revenues will be the sale of their technology - their line of stem cells for as many indications as possible. So for them, their short to medium-term success is likely to be measured by proving safety and some modest efficacy.

    NeuralStem will likely donate some of their cells to and perhaps even part-fund some of the translation work of labs like Tuszynski's to reap the benefits of greater efficacy in animal models using their technology not to mention the positive press for their stock prices.

    Business is business.
    Exactly right on this.

  6. #6
    Quote Originally Posted by GRAMMY View Post
    Exactly right on this.
    I think you both have this spot on.

  7. #7
    Super Moderator Sue Pendleton's Avatar
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    Right on. And they are sure enough that they released information that isn't politically expedient for the first time I've seen to the general public.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  8. #8
    I understand the incentives of a corporation, thank you. And they are free to develop, test and market the drug however they'd like. I agree business is business.
    But U2FP has invited them to W2W and is giving them a platform at an event dedicated to CURING PARALYSIS FROM CHRONIC SPINAL CORD INJURY. I imagine Richard Garr is going to the event to try to communicate how his company and product fits into this. The opinion of the scientists is that the cells alone won't do it. You've all rightly indicated that it may not be their strategy to push the neural stem cells past safety. It would be nice if someone would ask the questions to verify that their strategy is just that. Something tells me such an honest appraisal of the situation won't appear on the website or the CEO blog.

  9. #9
    Quote Originally Posted by ay2012 View Post
    It's worth noting in the article Paolo posts here http://sci.rutgers.edu/forum/forumdisplay.php?f=32 that it's said that the authors of the article (Tuszynski and others) that Neuralstem is touting in moving towards clinical trial actually OPPOSE the decision to move to trial and feel that doing so may jeapordize the therapy if it proves ineffective. They feel that they need to look at more relevant injury models (blunt injury as opposed to transection and even more chronic time points) and note that the proposed trial doesn't include the fibrin growth matrix nor the growth factor cocktail that were a part of their intervention.
    I'd love for someone at U2FP or anyone who attends W2W to ask Richard Garr how they can appeal to the work of these scientists and at the same time ignore their concerns about testing the therapy in humans.
    I wasn't surprised to read that Mark Tuszinski and Paul Lu are against Neuralstem trial. They are "just" researchers and perhaps don't have a deep marketing understanding.

    Consider that Neuralstem and Stem Cell Inc have a similar (if not even exactly the same) stem cell product to market.
    Consider also that they all know that the cells alone will have a limited benefical effect if all goes well, but the goal now is to make sure cells are safe ASAP before investing (or wasting) too much money to develop combination therapies.

    Stem Cell Inc. is already in trials, but with a complex and time consuming protocol (ASIA A, B, C, 12 patiets in total).
    Neuralstem is trying to overtake them, so they are going to do just 8 ASIA A patients directly within the FDA territory. It should be fast and easy to clear the "safety step" of the trial process.
    In the meanwhile (hopefully) in the labs they will move forward a bit with a combination therapy that will add groth factors etc.

    At the same time Neuralstem is also positioning in a more chronic side of the market (from 1 to 2 years after SCI), while Stem Cell Inc enroll patients max one year post SCI.

    If I had money to buy shares at the moment I would sligtly prefer Neuralstem even if I would buy some of both.

    Paolo
    Last edited by paolocipolla; 06-23-2013 at 09:06 AM.
    In God we trust; all others bring data. - Edwards Deming

  10. #10
    Quote Originally Posted by ay2012 View Post
    I understand the incentives of a corporation, thank you. And they are free to develop, test and market the drug however they'd like. I agree business is business.
    But U2FP has invited them to W2W and is giving them a platform at an event dedicated to CURING PARALYSIS FROM CHRONIC SPINAL CORD INJURY. I imagine Richard Garr is going to the event to try to communicate how his company and product fits into this. The opinion of the scientists is that the cells alone won't do it. You've all rightly indicated that it may not be their strategy to push the neural stem cells past safety. It would be nice if someone would ask the questions to verify that their strategy is just that. Something tells me such an honest appraisal of the situation won't appear on the website or the CEO blog.
    Of course these questions will be asked. I think you can trust that will happen at W2W. The more seasoned advocates will tell you that the answers and information you get will vary depending on many factors - eg commercial competition, being under peer review, non-disclosure agreements, market sensitivities, paranoia and downright spin/hype. As time goes by you will learn to read between the lines and work on scraps of information and even body language

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