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Thread: Seasteading & Clinical Trials?

  1. #21
    Quote Originally Posted by Wise Young View Post
    Pelican and Paolo,

    As I was leaving NYU in the mid-1990's, I gave some thought to creating a clinical trial network using ships. The ships would be equipped to do surgery and rehabilitaiton. They would stop at ports around the world and provide therapy and rehabilition, as well as followup examinations. The goal would not be to bypass regulatory agencies but rather to save money by not having to duplicate clinical trial facilities.

    I don't know what percentage of the world's population can be reached by ship but it must be at least half or more of people with spinal cord injury in the world. I even thought of having trucks on the ship that would have built in operating rooms that can be driven inland. England, Italy, and most of Europe are readily accessible. Each ship would have a helicopter to take teams of doctors inland. The East and West Coast of the United States, coastal areas of China, India, Central and South America, Australia, Japan, Taiwan, and Middle East should be accessible.

    Probably two ships would be sufficient. I went to the length of estimating the expenses of buying two old cruise ships and the cost of refitting and running them. It is cheaper than buying, building, and staffing a hospital. Just an idea.

    Wise.
    Wise,

    people with chronic SCI can easily travel. Don't foget that.

    With a boat you will have to staff the boat, crew members plus medical stuff.

    With a hospital you need just the medical stuff. You don't need to buy a building, you just rent what you need where is more convenient.

    Stem Stell Institute in Panama seems a possible model to consider.
    What is very important is to do things with scientific rigour and in a fully transparet way.

    Paolo

    P.S. here is a hospital ship example, but it is easier to move people with chronic SCI than a whole hospital and a rehab center IMO
    http://www.naveospedale.it/chi-siamo/
    In God we trust; all others bring data. - Edwards Deming

  2. #22
    Quote Originally Posted by paolocipolla View Post
    May I ask you a question?
    Why Stem Cell Inc. went to Switzerland to do the clinical trial?
    Paolo
    Paolo, It's my understanding that Aileen Anderson and Brian Cummings worked for many many years in collaboration with this company StemCells Inc. Dr. Armin Curt (Switzerland) was named the (PI) Principal Investigator for this particular trial. The collaborations are quite extensive.
    http://www.stemcellsinc.com/Science/...aborations.htm
    I would imagine the Swiss Health Authority would be easier to work with than the FDA.

    StemCells Inc. do currently have clinical trials in the USA for other indications.
    http://www.stemcellsinc.com/Therapeu...cal-Trials.htm

  3. #23
    Quote Originally Posted by Wise Young View Post
    Pelican and Paolo,

    As I was leaving NYU in the mid-1990's, I gave some thought to creating a clinical trial network using ships. The ships would be equipped to do surgery and rehabilitaiton. They would stop at ports around the world and provide therapy and rehabilition, as well as followup examinations. The goal would not be to bypass regulatory agencies but rather to save money by not having to duplicate clinical trial facilities.

    I don't know what percentage of the world's population can be reached by ship but it must be at least half or more of people with spinal cord injury in the world. I even thought of having trucks on the ship that would have built in operating rooms that can be driven inland. England, Italy, and most of Europe are readily accessible. Each ship would have a helicopter to take teams of doctors inland. The East and West Coast of the United States, coastal areas of China, India, Central and South America, Australia, Japan, Taiwan, and Middle East should be accessible.

    Probably two ships would be sufficient. I went to the length of estimating the expenses of buying two old cruise ships and the cost of refitting and running them. It is cheaper than buying, building, and staffing a hospital. Just an idea.

    Wise.
    Did you ever figure out the costs? I know it was almost twenty years ago, but it would be an interesting figure to hear.
    Dennis Tesolat
    www.StemCellsandAtomBombs.blogspot.com

    "Change does not roll in on the wheels of inevitability, but comes through continuous struggle. And so we must straighten our backs and work for our freedom."
    Martin Luther King

  4. #24
    Quote Originally Posted by Wise Young View Post
    Paolo,

    The SCI Community is larger than the AIDS community was in the 1980's when they convinced the FDA to create a new category of drug approval called "compassionate use". By the way, that category is still in existence and can be used for treatments of spinal cord injury, as long as you can show that there is no other therapy that works. The AIDS community, to my knowledge, never advocated circumventing the FDA. They worked with the FDA, NIH, and industry.

    Wise.
    I understand about 'compassionate use' but how could it be used in terms of spinal cord injury. With AIDS it was easy to prove (I think). "Let me use this new drug quickly, or I'll die." Would we fit the category if something really good came about? Would it work by speeding up all the clinical trial phases or would it eliminate clinical trial phases?
    I ask because you probably already know the answer without having to search for the information.

    In regards to the AIDS community vs the SCI community...
    Well, I'm still thinking about this question.
    Dennis Tesolat
    www.StemCellsandAtomBombs.blogspot.com

    "Change does not roll in on the wheels of inevitability, but comes through continuous struggle. And so we must straighten our backs and work for our freedom."
    Martin Luther King

  5. #25
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    Quote Originally Posted by StemCells&AtomBombs View Post
    I understand about 'compassionate use' but how could it be used in terms of spinal cord injury. With AIDS it was easy to prove (I think). "Let me use this new drug quickly, or I'll die." Would we fit the category if something really good came about? Would it work by speeding up all the clinical trial phases or would it eliminate clinical trial phases?
    I ask because you probably already know the answer without having to search for the information.

    In regards to the AIDS community vs the SCI community...
    Well, I'm still thinking about this question.
    As I said before, when the Grim Reaper is imminent, actions go into overdrive.
    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.

  6. #26
    Wise,

    when you have time I would like to know if you think my arguments make sense or not.

    Thank you.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

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