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Stem cell therapy for neurological diseases

a NeuroStemcell workshop held 29-30 September 2011 in Brussels, as tweeted by Andrew Smith from @euro_dayinsci

  1. euro_dayinsci
    If you ask who is this Andrew Smith tweeting: http://web.me.com/andrewjtsmith/project-management/ so, a non-scientist working with scientists longer than he dare admit.
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  3.  Opening Lectures: Bringing stem cells to the clinic; the European and American experience
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    John Sinden outlining work of ReNeuron as UK's only clinical stage stem cell therapy company. Cost driver is manufacturing, incl. testing.
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  5. euro_dayinsci
    Product manufacture for Re-Neuron's individual treatments is a 5 day process, testing in parallel with approval released on final day. Fast!
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  6. euro_dayinsci
    UK regulatory route map for stem cell research / advanced therapy manufacture involves 12 agencies - looks complex but do-able says ReNeuron
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  7. euro_dayinsci
    Catherine Priest (Geron) on spinal cord contusion therapy developed in rats: clinical studies require follow-up monitoring over 15 years.
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  8. Session 1: The clinical perspective
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    Insoo Hyun (Case) on ISSCR guidelines for clinical translation: degree of regulation/oversight should be proportionate to level of risk.
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  10. euro_dayinsci
    Hyun: research using public resource must address how it will benefit society - plan to achieve this should exist before donors invited.
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  11. euro_dayinsci
    Roger Barker: invasive trials recruit few patients so can't be categorical on safety; efficacy testing limited. Easier for e.g. oral route.
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  12. euro_dayinsci
    Barker's Conundrum: how to get funding for sufficiently multi-year studies AND motivate patients to stay enrolled for the whole duration?
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  13. euro_dayinsci
    Barker: long term (near 15 years) overwhelmingly shows big stemcell therapeutic gain like change in brain. Relative gain invisible <5 years.
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  14. euro_dayinsci
    Sinden: delivery of cells into patient takes 4 hrs. What best to do to control patient for the 4 hrs to avoid awareness they're the control?
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  15. euro_dayinsci
    Marc Peschanski (Evry): sham surgery (the extreme placebo suggested in USA) is mooted for control patients: can this be really ethical?
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  16. euro_dayinsci
    Priest: there should be work towards a recognition, understanding and acceptance that the "perfect trial" cannot designed and implemented.
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  17. euro_dayinsci
    Oliver Bruestle (Bonn): The community should invest in more time to develop further the underlying research to build trust in this field.
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  18. euro_dayinsci
    Bruestle: we've heard it can take to 15 years for benefit to manifest in patient. We need additional convincing arguments to win the public.
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  19. euro_dayinsci
    Hyun: In USA the tight regulation that controls what wins FDA approval is not what governs how doctors can experiment in medical practice.
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  20. Session 2: Safety & regulatory issues
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    Peschanski: we need to understand that the regulators have their job to do and are eager to get the best systems in place.
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