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Thread: New Zealand Gets Approval for SCI Clinical Trial

  1. #1

    New Zealand Gets Approval for SCI Clinical Trial

    Newsletter May 2011
    - Great News
    We have now received the final
    approval from the Multiregion Ethics

    Committee for our first Clinical Trial!




    Progress- we can now start the real work of

    getting the Trial underway.
    We want to thank everyone who has helped in developing the Trial Protocol over many years including those who helped with lobbying for the Trial. It has been a team effort: researchers, people with SCI - who have helped with letter writing, and especially Noela Vallis who has played an essential part in lobbying at all levels. We have also had active support from Ministers of Health and many other MPs over the past five years. This support has been invaluable and has helped to remodel the ethics review process so that the voices of affected people and the researchers themselves, are now heard much more clearly and effectively. Thank You! And special thanks to the Lion Foundation for their invaluable support for the Trial.



    Purpose of the first clinical Trial



    The first Trial will provide important information on the effectiveness of olfactory mucosal autotransplantation (OMA) - the procedure developed by Dr Carlos Lima for people who have severe chronic spinal cord injury. The Lima procedure involves transplanting olfactory tissue from the roof of the nose into a ‘cleaned out’ spinal cord injury site. The treatment involves both the surgery and intensive follow-up rehabilitation treatment. Although about 200 people have had the surgery the Portuguese team have not carried out a specific trial that proves the amount of benefit from the treatment. The Portuguese work has, however, been invaluable for showing that the procedure has only small risks.



    The SCSNZ Trial will use a controlled research
    process. This is needed to evaluate the amount of
    benefit from OMA surgery (followed by rehabilitation), when compared with rehabilitation therapy alone. It is important that this work is carried out as the amount of benefit has not been measured critically by the research team which developed the method. The information is needed to help with the design of more advanced trials
    in the future. Apart from evaluating the effect from
    olfactory tissue cells in humans we need information about the effects of rehabilitation therapy in people who have had surgery on the spinal cord and in control subjects. The first Trial will take important first steps that will set the stage for later clinical trials. We expect that later trials will be able to achieve a lot more benefit and
    recovery of function for people with spinal cord injury but we cannot plan these trials properly until we have results from the early studies.
    The first Trial will provide important information on
    organisation and running of treatment Trials in people with spinal cord injury. We will be gathering experience about practical issues that affect running of a Trial where the participants are living in their own home environments and are scattered across New Zealand. We expect to learn a lot about the issues of coordinating and
    monitoring rehabilitation activities, ensuring that
    rehabilitation occurs consistently and about keeping in touch with people who have a wide range of different issues facing them in their own home environments. The research team will evaluate the effectiveness of our methods for coordinating, monitoring and measuring the
    intensity of rehabilitation activity at long range from the research centre in Dunedin and of assessing health needs of the people involved.
    We will also evaluate a large number of medical
    issues that affect people with spinal cord injury as these may provide insights into the impact of the surgery and rehabilitation, and on the effect of taking part in a Trial. The data will be recorded regularly with input from the participants, and health specialists who will monitor for a wide range of effects.



    Recruitment for the trial



    We are now starting to recruit people for the first
    Trial. The selection criteria for the trial are listed below. If you know of people who may fit the criteria and may be interested in participating, please let them know about the Trial and pass on our contact details:
    enquiries@scsnz.org.nz






    .

    A NOT-FOR-PROFIT ORGANISATION DEVOTED TO DEVELOPING

    CURE FOR SPINAL CORD INJURY AND RELATED PROBLEMS

    428 Hinuera Road
    RD2, Matamata.
    Phone (07) 888 1728
    Fax (07) 888 1776
    email: noela.scsnz@xtra.co.nz
    SPINAL CORD SOCIETY
    NEW ZEALAND INC
    c:\lab docs\reports\2011\newsletter 20110509.doc 2/2
    The main recruiting process will work through
    General Practitioners. We are writing to GPs in the
    major centres and nearby districts with information
    about the Trial. The letter will ask them to pass details about the trial on to any patients with complete thoracic spinal cord injury. Our past experience indicates that only some GPs pass the information on to their patients.
    We will need your support in helping to distribute
    information about the Trial to anyone who may be
    interested. Interested people will be able to contact their GP and ask for the Information Sheet and form for registering interest in the Trial. The Information Sheet and other forms are also available from our Office at the Research Centre for anyone who contacts us directly.
    The Clinical Research Team
    Dr James M (Jim) Faed Coordinator
    Mr Nicholas Finnis Neurosurgeon
    Dr LJ (Vic) du Plessis Neurologist & Rehab Physician
    Dr John Mottershead Neurologist
    Dr Xianghu (Shaun) Xiong Rehabilitation Specialist,
    Medical Director, Burwood Spinal Unit
    Mr D Scott Stevenson Ear Nose and Throat Surgeon
    Mr Dean R Ruske Ear Nose and Throat Surgeon
    Dr Peter K Taylor Clinical Neurophysiologist,
    Dr Leigh Hale Physiotherapist
    Dr Glenda Wallace Clinical Neuropsychologist
    Ms Bhairavi Paranjpe Data collator and Trial Secretary
    Prof. Grant Gillett Bioethicist & retired Neurosurgeon
    Sharon English Consultant Urologist
    Assoc. Prof. Giles Plant Neuroscientist
    Research Centre:
    Dr Paul Turner Scientist
    Charlotte Wilson Assistant Research Fellow
    Main Selection Criteria for the First Trial:






    A complete spinal cord injury at the thoracic (chest) level –

    no function below the level of the injury.






    The injury occurred 2-7 years ago.



    Age: 18 to 35 years



    No severe illness or disability apart from spinal cord injury



    Must be willing to travel to Dunedin for regular testing and

    to Christchurch if selected to have the transplant surgery.






    Must be willing to commit to the programme of

    rehabilitation therapy.


    Fundraising







    SCSNZ Executive and in particular, Noela Vallis

    are now very active with fundraising for all of the


    Society's research work. Please help to spread the

    word about the Society's research activities.







    All of the major banks now accept donations to

    Spinal Cord Society NZ by clicking on the preregistered


    bill payment button. Details vary slightly

    between banks but you should be able to find the
    information.







    The SCSNZ Website has a donation link for credit

    card donations – see



    Make a Donation.



    An 0900 number is also available for making a $20

    donation: 0900 SPINE (0900 77463).





    If you know of potential major donors or bequests,

    please contact Noela Vallis: 07 888 1728 or


    noela.scsnz@xtra.co.nz.

    We will continue to need active fundraising with
    support from both private donors of large and small donations and from businesses over the next 5-10 years as we make progress in developing treatments for spinal cord injury.






  2. #2

  3. #3
    Gogogo!
    "It's not the despair, I can handle the despair! It's the hope!" - John Cleese

    Don't ask what clinical trials can do for you, ask what you can do for clinical trials. (Ox)
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  4. #4
    Nice!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

  5. #5

    Smile New Zealand Clinical Trials

    This gives me hope that my daughter may be picked for clinical
    trial for chronic sci at cervical level if every phase of this trial shows improvement
    for chronic 2 - 7 yrs. injury thoriac T level SCI.
    Aggie Mom 2007

  6. #6
    Senior Member 0xSquidy's Avatar
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    I was talking about this trial with a researcher some time ago, when I didn't have all the information yet, but i haven't seen any changes of what we expect so I'll share with you what this person told me:

    "My opinion is that they intend to do the same thing that had already been done in Australia using mucosa cells, in the first phase. Then they want to combine that with trophic factors or other strategies. They say they relay on animal experiments but that's half true. They talk about OEG, but they make no distinction between the results they got with the bulb against the results obtained with mucosa. It's well known that mucosa doesn't work as good as bulb cells. In case of mucosa, there are groups with positive results and groups with negative results. You won't find that with bulb cells.

    Of course there are records about OEG, but that's half true as well because there are no solid records in the scientific literature about that the combination of mucosa cells with trophic factors improve the results of the mucosa alone. In fact, there's an article that states the opposite: they combine mucosa cells with a trophic factor and they get worse results.

    Conclusion: I think that what they will do is no different than what's already been done, and their intention of mix with a trophic factors, has no scientific base"

    If you want to think I'm always the Grinch, good for you. But this trial seems so improvable with so little changes.
    Don't ask what clinical trials can do for you, ask what you can do for clinical trials.

    Fenexy: Proyecto Volver a Caminar

    http://www.fenexy.org (soon in english too)

  7. #7
    Oxsquidy, I doubt they would waste good time and money doing a clinical trial on something that has already shown poor results unless there was a fair chance they could tweek it somehow and hope for a more positive result..

  8. #8
    Senior Member 0xSquidy's Avatar
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    Quote Originally Posted by malthouse View Post
    Oxsquidy, I doubt they would waste good time and money doing a clinical trial on something that has already shown poor results unless there was a fair chance they could tweek it somehow and hope for a more positive result..
    Of course, that has never ever happened right...
    Don't ask what clinical trials can do for you, ask what you can do for clinical trials.

    Fenexy: Proyecto Volver a Caminar

    http://www.fenexy.org (soon in english too)

  9. #9
    Senior Member lunasicc42's Avatar
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    real question: I have always wondered how they expect to get better or different results from what dr. Lima has already got in Portugal?
    "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
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  10. #10
    "If you haven´t the strengh to jump a river, changing your shoes won´t give you more chances to make it."

    This is Lima 2.0, nothing new.
    -Ramps in buildings are necessary, but it would be usefull to have another ones for people (mind/heart).....

    -Hoc non pereo habebo fortior me

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