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Thread: Geron hopes to restart stem-cell study in 2010

  1. #11
    [QUOTE=chasb;1115033]As you blanketed my entire post, this will be my first response on your request.

    What does that mean? 'blanketeted your entire post' What response?

  2. #12

  3. #13
    Quote Originally Posted by Duran View Post
    ... because they continue playing with fire, manipulating public opinion and cheating potential investors, so that maybe FDA has just got sick of their obstructions . Seriously, until now I was their great fan, but they failed me. What they are doing, is a circus and let's hope there would be more serious companies on the market by this time. Not good example for persuading people that politics and funding are the biggest obstacles on the road to a cure, isn't?
    Your statment makes no sense, is sensationalist and outright nonsense (lie?). And then 2 others reply to your disinformation thus "spinning the stupidĀ©" and propagating more nonsense!

    From the press release:

    Geron and FDA Reach Agreement on Clinical Hold

    Company and Regulatory Agency Define Path to Re-Initiate Human Trials for Spinal Cord Injury


    MENLO PARK, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN) today announced the company’s plan to advance clinical development of its human embryonic stem cell (hESC)-based product, GRNOPC1, for the treatment of spinal cord injury. The plan is expected to enable Geron to re-initiate the Phase I clinical trial of GRNOPC1 in patients with complete thoracic spinal cord injury and to support future expansion of the trial to patients with cervical injuries.

    Geron has been performing a series of preclinical studies to expand the clinical program for spinal cord injury beyond patients with complete thoracic injuries. The company’s goal is to test the safety and utility of GRNOPC1 in patients with complete and incomplete (less severe) injuries in both thoracic and cervical regions.

    As announced previously, in one preclinical study, a higher frequency of animals developed cysts in the injury site than had been seen in numerous foregoing preclinical studies with clinical grade GRNOPC1.
    These cysts are non-proliferative, confined to the injury site, smaller than the injury cavity, and were not associated with adverse effects on the animals. As part of ongoing work to optimize GRNOPC1 manufacturing and product release, the company developed new candidate markers and assays. Data from studies using the new markers were submitted to the FDA. The IND for spinal cord injury was placed on clinical hold pending FDA review of the data.

    Geron will complete a confirmatory preclinical study using GRNOPC1 that has been characterized by the new markers and assays, as agreed upon in discussions with the FDA. As part of the ongoing plan to advance clinical development to cervical patients, Geron had already initiated this preclinical study in an animal model of cervical injury.

    In discussions with the company, the FDA has advised that it concurs with Geron that positive data from this study can be used to support both release of the clinical hold and expansion to cervical patients. Geron expects the data from this study to enable re-initiation of the clinical trial in the third quarter of 2010.
    Last edited by eks; 10-31-2009 at 05:22 PM. Reason: Brevity
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  4. #14
    .-.. . - .----. ... / ... . . / .. ..-. / -.-- --- ..- / -.-. .- -. / ..-. .. --. ..- .-. . / --- ..- - / .. / .--- ..- ... - / .. -. -.. .. -.-. .- - . -.. / -.-- --- ..- / .- .-. . / .- / -- --- .-. --- -. .-.-.- / - .... .- - / .. ... / .-- .... -.-- / .. / -. . ...- . .-. / .- -. ... .-- . .-. . -.. / -.-- --- ..- .-. / --.- ..- . ... - .. --- -. .-.-.- / -.-- --- ..- / -. . .. - .... . .-. / ..- -. -.. . .-. ... - .- -. -.. --..-- / -. --- .-. / .- .--. .--. .-. . -.-. .. .- - . / -. .. . - --.. ... -.-. .... . .-.-.- / .. / -.. --- ..- -... - / -.-- --- ..- / .... .- -.. / . ...- . .-. / .... . .- .-. -.. / --- ..-. / .... .. -- --..-- / .--. .-. .. --- .-. / - --- / - --- -.. .- -.-- .-.-.-
    Last edited by chasb; 10-31-2009 at 09:29 PM.

  5. #15
    Senior Member Duran's Avatar
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    Quote Originally Posted by eks View Post
    Your statment makes no sense, is sensationalist and outright nonsense (lie?). And then 2 others reply to your disinformation thus "spinning the stupidĀ©" and propagating more nonsense!
    eks,

    I am not sure what puzzled me more, if that was date of your injury (you are only two years post) or your infantile post. Though I'd like to raise a point in the discussion, it would be counterproductive, I suppose. It is just like talking to virgin about sex.

    I am not going to play this game with you in any way! If you has nothing constructive to add, just shut up!
    2016

  6. #16
    Quote Originally Posted by Duran View Post
    eks,

    I am not sure what puzzled me more, if that was date of your injury (you are only two years post) or your infantile post. Though I'd like to raise a point in the discussion, it would be counterproductive, I suppose. It is just like talking to virgin about sex.

    I am not going to play this game with you in any way! If you has nothing constructive to add, just shut up!
    I have no doubt that you are very puzzled.
    ______
    Awe at my magnificent coq!

    "You may say I'm a dreamer
    but I'm not" - J. Lennon

  7. #17
    Please cool it.

    I understand that emotions are running high. Some people have invested much hope and effort on getting the Geron trial going. If you don't believe that the therapy will work, don't denigrate others for their belief. Please also back your opinions with evidence. Otherwise, the discussion just becomes tit for tat and contributes little information.

    To my knowledge, the FDA is considering data that Geron has provided and Geron is hoping that the FDA will give them the go-ahead to do the trial. Several centers had been ready to start the trial, including Shephard in Atlanta when some preclinical data submitted by Geron caused the FDA to put a hold on the trial last August.

    That data suggested that the cells may be form microcysts in the spinal cord of rats. Geron has now developed a technique to identify these cells and sorted them out of the cells that will be transplanted in the clinical trial. They hope that the FDA finds this data to be convincing and allows them to go forward with the trial.

    I have spoken to officials in the company. Their stance is that they are committed to the trial and plan to go ahead if and when the FDA approves the trial. They have invested a great deal into the trial (over $44 million in preclinical studies alone) and they want to see if through, at least through phase 1 trials.

    While many people may be skeptical about the potential outcome of this trial, it is a phase 1 trial, intended to demonstrate safety and feasibility of the first human embryonic stem cell derived cell transplants. Geron has done everything that it can to ensure the safety of the treatment. In my opinion, the trial is likely to reach its primary outcome, i.e. to test the safety of such transplants.

    Please consider what would happen if Geron were to withdraw this trial. This would essentially mean that they are giving up their bid to develop embryonic stem cell therapies, not just for spinal cord injury but for other conditions as well. I suspect that they will not be able to raise much money in the future for embryonic stem cells if they give up now.

    Let's look at each of the possible outcomes of the trial.
    1. The trial shows that OPC1 cell transplants produces tumors in the spinal cord associated with loss of function but the tumors disappears when immune suppression is stopped. This outcome should lead to a strong recommendation against transplanting human embryonic stem cells or its derivatives unless bulletproof technology is developed against tumor formation.
    2. The trial shows that OPC1 cells have minor effects on the subjects, i.e. a transient improvement in sensation, the cells were detected during the time that immunosuppression was being given, but cannot be detected on MRI on later followup, and the subjects don't show any change in function. This would suggest that the cells are being immune-rejected.
    3. The trial shows that OPC1 cells do not form tumors and MRI show possible evidence of cell survival, and the subjects show some improvement of function that may or may not be due to the natural recovery of patients, even with ASIA A injuries. This would support going on ahead with phase 2 trials to ascertain the best dose and timing of treatment.


    All three of these scenarios will provide important and useful information. I do not list the worst case scenarios, i.e. patients die or patients are cured by the treatment. Neither are likely. Is this trial worthwhile?

    Wise.
    Last edited by Wise Young; 11-01-2009 at 11:35 PM.

  8. #18
    Senior Member lunasicc42's Avatar
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    what exactly did you mean when you say "is this trial worthwhile? ". Sorry I missed something.
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  9. #19
    So it doesnt work in chronic injuries and its unsafe. Wow how do they get this close to trials while things that show real promise get put on the back burner? That blows my mind. We really gotta get Dr Wise what he needs to bring real deal therapies to trial. Just my own personal thoughts.

  10. #20
    Quote Originally Posted by lunasicc42 View Post
    what exactly did you mean when you say "is this trial worthwhile? ". Sorry I missed something.
    It is a question. Is this trial worthwhile? I am asking you.

    I said that I thought that all three scenarios will provide useful and important information. So, obviously, I think that the trial is worthwhile. Let me lay out the reasoning for why this information is useful.

    This is the first therapy applying an oligodendroglial progenitor cell to the spinal cord. Several groups have reported that such cells may be beneficial in spinal cord injury. The first report of this was from John McDonald in 1999, when he reported that transplantation of mouse embryonic stem cells into contused rat spinal cords improve functional recovery in the rats. The second was by Keirstead, who developed these cells, and showed that they are beneficial when transplanted within 2 weeks after spinal cord injury. It would be of interest to see if this treatment is beneficial. It may be that these cells provide certain factors that will ameliorate the injury. Another possibility is that the cells may survive, i.e. not be immune-rejected. If so, they may myelinate axons.

    If the trial shows that these cells do survive and improve function, it would challenge a great deal of conventional wisdom, i.e. that heterografts (from another individual) will be immune-rejected albeit with a delay from the spinal cord and that oligodendroglial precursors are neuroprotective, neuroreparative, or even neuroregenerative in human. Many scientists are worried that the treatment may turn out to be dangerous, i.e. forms a teratoma in the spinal cord. Yes, there is a certain risk to doing this clinical trial. However, if one doesn't take that risk, there is no way that one can find out.

    The cells have been transplanted into many animals without showing any evidence of tumor formation. This doesn't necessarily mean that the cells will do the same when transplanted into humans. But, it is unlikely to do so. Will it improve functional recovery? I don't know and I don't think that anybody knows for sure. If the cells do not improve function at all in any of the people, then I guess we will know. That knowledge is important. We can then go on to other therapies. Please note that if it doesn't show any benefit, this may be because the wrong dose or timing of therapy may have been used but it would be difficult to proceed nobody shows any benefit or some people get worse. However, if it does show some benefit, phase 2 trials must be carried out to find out the optimal dose and timing of the transplants and possible combination therapies.

    Wise.
    Last edited by Wise Young; 11-01-2009 at 11:52 PM.

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