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Thread: Miami Project take on Geron Clinical Trial

  1. #1
    Senior Member MikeC's Avatar
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    Miami Project take on Geron Clinical Trial

    Got my e-newsletter from the Miami Project. Thought their take on the Geron trial and their plans were interesting:

    A FIRST FOR SPINAL CORD INJURY
    The calls have been coming in. “…Is The Miami Project going to be involved with the embryonic stem cell trial? Where in the United States will this treatment be available? Who will be able to participate?...” These are some of the questions The Miami Project is getting in response to the announcement that the Food and Drug Administration (FDA) has given first ever clearance for a Phase 1 trial to test the safety of a human embryonic stem cell-based therapy in patients with acute spinal cord injury.
    The trial sponsor is Geron Corporation, a biopharmaceutical company based in California. Geron is a world leader in the development of human embryonic stem cell-based therapies and reportedly spent approximately $45 million dollars to prepare its Investigational New Drug application for this important SCI trial.
    Geron’s trial will test the safety of human embryonic stem cells in a limited number of acutely injured patients. Since the effects of this type of cell transplantation into the human spinal cord are unknown, it will be critical to rigorously assess the safety and long term risks of the treatment in a well-designed clinical trial. Only through these trials and with continuing basic research in stem cell biology will we understand the promise and limitations of cellular therapies to treat SCI and other human diseases.
    Over the last several years, The Miami Project has been following Geron’s progress and some of our investigators have served as advisors to Geron’s research and development team. Clearly, this first U.S. human embryonic stem cell study for spinal cord injured individuals is an important development in the field of regenerative medicine.
    “In our opinion, says Dr. W. Dalton Dietrich, “this represents a significant shift in the FDA’s evaluation of the risks and benefits of cell therapies. Importantly, this is a very good thing for The Miami Project’s development of a Schwann cell transplantation trial. We look forward to receiving the same permission from the FDA to start our human Schwann cell trial in not only acute but also chronically injured volunteers.”
    Before The Miami Project can submit its own IND application, we must complete FDA-required safety studies. Those studies are underway and The Miami Project is confident, especially in light of recent developments, that the FDA will also give clearance for a future Schwann cell transplant trial.
    Confidence is high because in preclinical studies, adult Schwann cells have been shown to repair the insulation, known as myelin, around nerve cells, and to improve function after SCI in laboratory experiments. Additionally, in contrast to the potential limits of embryonic stem cells, there are several advantages to using adult cells, such as Schwann cells. Adult cells may not be as prone to forming tumors. Another advantage, with Schwann cells in particular, is the cells can be taken from a person’s own body for transplantation into their spinal cord, a treatment approach that may reduce the likelihood of transplant rejection and other unwanted effects.
    While Geron’s stem cell transplant will initially be tested only in patients with acute spinal cord injury, The Miami Project intends to examine the safety of Schwann cell transplants in both the acute and chronically injured. Certainly, these are exciting times in the field of SCI research. The Miami Project’s continued hard work to successfully translate exciting laboratory findings to the clinic offers real hope for people living with paralysis.
    (Note: Please see www.geron.com for further information about where this clinical trial will be conducted and who may volunteer.)
    T12 Incomplete - Walking with Crutches, Injured in Oct 2003

  2. #2
    Interesting. How nice of them to use Geron to promote their own work. They even threw in a little zinger that their work is not just for acutes but also for chronics. In addition they hinted esc cause tumors.
    Last edited by manofspine; 02-10-2009 at 06:40 PM.

  3. #3
    Senior Member Quadcessible's Avatar
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    Give it a break!

    Quote Originally Posted by manofspine View Post
    Interesting. How nice of them to use Geron to promote their own work. They even threw in a little zinger that their work is not just for acutes but also for chronics. In addition they hinted esc cause tumors.
    Why do people have to seek the negative side when reading between the lines? I'd think you would be glad that it will apply to chronics? They stated nothing that wasn't true, and I just read it for what it was; as a statement regarding Geron, and a statement of their work. Take it for what it is, lets hope it all leads to further clinical trials, wherever they come from, and that they show success.

  4. #4
    Quote Originally Posted by ChipD View Post
    Why do people have to seek the negative side when reading between the lines? I'd think you would be glad that it will apply to chronics? They stated nothing that wasn't true, and I just read it for what it was; as a statement regarding Geron, and a statement of their work. Take it for what it is, lets hope it all leads to further clinical trials, wherever they come from, and that they show success.
    Geron trial is in the news and Miami used that title to get attention, belittle the geron trial and make theirs look better.

    It wasn't reading between the lines.

    If Miami wants to promote there work, they don't have to do it at the expense of Geron.

    And don't think researchers are guilty of palying into the esc/adult stem cell politics

    “These cells are chosen because the nasal lining is the only situation where nerve fibers are known to be able to grow throughout adult life,” it says.

    “If this technique can be transferred to humans, the patient can be his/her own cell donor,” team leader Prof. Geoffrey Raisman has pointed out. “This will avoid the need to use embryonic tissue, to find donor individuals, foreign stem cells, or to use powerful designer drugs with unknown side-effects.”

    ‘Hope for millions’

    Van Gend said the nerve cells Geron plans to inject into patients could be better and more safely obtained from adult stem cells – as is already being done at the Australian National Adult Stem Cell Center – or from iPS cells.

    “Both these methods are superior, as they produce cells of an exact genetic match for the patient – which the Geron cells do not – and they do not require any exploitation of the human embryo,” he said.
    http://www.cnsnews.com/Public/Conten...x?rsrcid=42500
    Last edited by manofspine; 02-11-2009 at 06:16 PM.

  5. #5
    Quote Originally Posted by manofspine View Post

    If Miami wants to promote there work, they don't have to do it at the expense of Geron.
    Nor at the expense of ESC research

  6. #6
    ‘Hope for millions’
    What millions? Aren´t this trials only for acutes?
    -Ramps in buildings are necessary, but it would be usefull to have another ones for people (mind/heart).....

    -Hoc non pereo habebo fortior me

  7. #7
    Quote Originally Posted by Isildur View Post
    What millions? Aren´t this trials only for acutes?
    chronics ain't millions either, if it works and is safe maybe other diseases could be cured too. You aren't being fair. Nor is Miami Project and some adult stem cell researchers

  8. #8
    Interesting, yes. I don't fault them for trying to position themselves in the market. For my narrow viewpoint, they've always appear to promote themselves as a charitable business. What I don't understand is why it is taking them so long to begin their cell transplants. It feels like they keep reiterating the same information over -- I wish there was more honesty and transparency. But there's the other end of the stick -- at least they're doing work to help "us" in some dimension. As long as it is not the expense of other researchers, I guess I can tolerate their opinion.

  9. #9
    My only criticism: they didn't answer the question.

    Opening:

    The calls have been coming in. “…Is The Miami Project going to be involved with the embryonic stem cell trial? Where in the United States will this treatment be available? Who will be able to participate?...”
    They never answer.
    ...it's worse than we thought. it turns out the people at the white house are not secret muslims, they're nerds.

  10. #10
    Quote Originally Posted by Chaz19 View Post
    Interesting, yes. I don't fault them for trying to position themselves in the market. For my narrow viewpoint, they've always appear to promote themselves as a charitable business. What I don't understand is why it is taking them so long to begin their cell transplants. It feels like they keep reiterating the same information over -- I wish there was more honesty and transparency. But there's the other end of the stick -- at least they're doing work to help "us" in some dimension. As long as it is not the expense of other researchers, I guess I can tolerate their opinion.
    So did they not try to say esc causes tumors?

    or to use powerful designer drugs with unknown side-effects

    an Gend said the nerve cells Geron plans to inject into patients could be better and more safely obtained from adult stem cells – as is already being done at the Australian National Adult Stem Cell Center – or from iPS cells.

    “Both these methods are superior, as they produce cells of an exact genetic match for the patient – which the Geron cells do not – and they do not require any exploitation of the human embryo,” he said.

    How could you miss that?

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