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Thread: Clinical Trials

  1. #461
    Senior Member
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    Quote Originally Posted by keeping on View Post
    i received an e-mail replyu from Shepers regarding the Geron Trial. I asked when results will be given to the public. The response stated that it will be years for this project to get the results. the response said they will investigating the safety of the therapy. This we all know. I was disappointed in the results part. Again, my belief of a real therapy that we all can benefit from is becoming a timeframe that is not defined and will not affect me or many of us.

    keeping on
    Letters received isn’t cures. Cures are long term dedicated follow-in.

  2. #462
    Senior Member
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    Quote Originally Posted by keeping on View Post
    i received an e-mail replyu from Shepers regarding the Geron Trial. I asked when results will be given to the public. The response stated that it will be years for this project to get the results. the response said they will investigating the safety of the therapy. This we all know. I was disappointed in the results part. Again, my belief of a real therapy that we all can benefit from is becoming a timeframe that is not defined and will not affect me or many of us.

    keeping on
    Rather looks that way. Disappointing after the lead up.
    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature.

  3. #463
    Quote Originally Posted by keeping on View Post
    i received an e-mail replyu from Shepers regarding the Geron Trial. I asked when results will be given to the public. The response stated that it will be years for this project to get the results. the response said they will investigating the safety of the therapy. This we all know. I was disappointed in the results part. Again, my belief of a real therapy that we all can benefit from is becoming a timeframe that is not defined and will not affect me or many of us.

    keeping on
    This Phase 1 trial is purely for safety. They've just started recruiting patients and they wait 30 days between patients. A lot of time will pass before the patients responses are made public. They will need time to work with any adverse events (if they should happen) and be watching for any unwanted symptoms, etc... It may take quite some time for safety concerns to develop. The first stop gap for the first patient won't even happen until the end of this year. It's a very long timeframe if you've ever analyzed it out. In addition to that they are injecting "complete" injuries.

    They've just barely started Phase 1 "safety".
    (Phase 1 data should near completion around October 2012, depending when the last patient is enrolled.)

    (It would be silly to announce a miracle cure after the first 2 people are injected and then have them die from complications or have cell rejection 9 or 10 months later...They just can't prove human safety in a petri dish. Effectiveness is proven in Phase 2-3-4 anyway...)

    In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

    In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

    In Phase III clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

    In Phase IV clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

    With the given timeframes, many people resort to medical tourism and just have unproven cells injected in other countries when they get into a hurry.
    Last edited by GRAMMY; 04-15-2011 at 12:11 PM.

  4. #464
    Quote Originally Posted by GRAMMY View Post
    This Phase 1 trial is purely for safety. They've just started recruiting patients and they wait 30 days between patients. A lot of time will pass before the patients responses are made public. They will need time to work with any adverse events (if they should happen) and be watching for any unwanted symptoms, etc... It may take quite some time for safety concerns to develop. The first stop gap for the first patient won't even happen until the end of this year. It's a very long timeframe if you've ever analyzed it out. In addition to that they are injecting "complete" injuries.

    They've just barely started Phase 1 "safety".
    (Phase 1 data should near completion around October 2012, depending when the last patient is enrolled.)

    (It would be silly to announce a miracle cure after the first 2 people are injected and then have them die from complications or have cell rejection 9 or 10 months later...They just can't prove human safety in a petri dish. Effectiveness is proven in Phase 2-3-4 anyway...)

    In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

    In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

    In Phase III clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

    In Phase IV clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

    With the given timeframes, many people resort to medical tourism and just have unproven cells injected in other countries when they get into a hurry.
    Grammy: thank you for clarifying Phases of clinical trials. What i
    would like to know is when will clinical trials for chronics start? I have
    read there starting one up in New Zealand using Dr. Lima's approach
    of using nose cell OEC stem cells with intensive physical therapy
    only asking at this time candidates be T level and complete. New Zealand
    is awaiting approval that was in March. I received info from apparlyzed forum
    in February 2011.
    Aggie Mom 2007

  5. #465

    Smile Cancer Drug may be Repurposed for spinal cord injuries

    just received hopeful if it would work for chronics

    http://www.ninds.nih.gov/news_and_ev...I_scarring.htm
    Aggie Mom 2007

  6. #466
    looks like for acutes only, chronics would already have scar tissue issues........

  7. #467
    ineedmyelin, Wise says that scar tissue is not the same as these other views from researchers on this. If , I'm not mistaken, Wise, seems to feel that he can handle the "scar tissue" scenerio. I don't know, buit it is confusing with the different views on it.

  8. #468

    Let me be a guinea pig, any takers?

    My question is where, when, which one & finally how much.
    I am on these forums for a long time, keep reading the same things again & again, the cure for SCI isnt possible in our life time unless you take the risk like the title of this post.
    C4-5,incomplete, 27th Dec.2000

  9. #469
    Quote Originally Posted by djas57 View Post
    My question is where, when, which one & finally how much.
    I am on these forums for a long time, keep reading the same things again & again, the cure for SCI isnt possible in our life time unless you take the risk like the title of this post.
    Everyone was tired!

  10. #470
    Christopher Reeves site shows article of a chronic in a clinical trial in 2009 for electrical spinal cord stimulation and locomotor training. Person was injured in 2006 c7 t1 and is now able to move toes, feet, ankles and legs on command. Is able to stand supported. Panamain jockey goes to Switzerland for stem cell clinical trial. Jockey injured in 2010 in
    horserace in U.S. was denied acceptance in Geron trials?
    Aggie Mom 2007

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