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Thread: UPMC clinical trial

  1. #21
    Quote Originally Posted by Tyran21 View Post
    Grammy, is there so many major clinical trials like these past 2-3years last time? Or is it just like this all along? sorry for my poor command of english.
    No, your English is fine Tyran21. I think I understand what you are asking. I believe we now have many more relevant trials being tested by biotech companies along with more trial sites made available than in the past. Our clinical trial list at u2fp is a lot bigger than past years. We have neurosurgeons and hospitals now that have to compete for patients a bit because of the different factors but they do need business and they're willing to work within the guidelines that clinical trials must meet. Many are trauma one hospitals and can easily meet the criteria if they have personnel with expertise there to deliver the therapy. Another factor is timing and patient condition especially on some of the acute trials you see. Biotech's will spread lots of sites out across the country to try to capture as many acute patients as possible. There's only a certain percentage of SCI that are actually willing to participate. It's easier to get the treatments to the hospitals that qualify with treatment protocols and delivery than trying to transport patients that are in poor condition. For instance the Neuralstem trial used a very special cannula for delivery of the cells that not all hospitals had available. Acute trials are definitely more difficult to fill with participants.

    We do have a network for SCI trials amongst hospitals but it doesn't appear to make much difference when sponsors set up their sites. Many hospitals in the network participate, but you'll also see hospitals participating that have nothing to do with the SCI network. I think there are different factors at play depending on the treatment that needs to be tested and if the hospital site can meet all the designated protocol required in the trial. A factor is also if proper cell storage is available and specialized equipment is available like the cannulas or the new one that will InVivo will be using for laying trails of neural cell scaffold. Not all neurosurgeons have the expertise to do a trial and some don't want the paperwork required for data collection. I hope this answers your questions.
    Last edited by GRAMMY; 04-04-2016 at 12:24 PM.

  2. #22
    Thanks for the answer, hopefully one of these many trials produce some good results

  3. #23
    Grammy, I have read somewhere that InVivo will give neural stem cells to the first five patients that have received the scaffold. If you know anything about it, thanks.

  4. #24
    Grammy Arethere usually neurosurgeons involved with these clinical trials, as in part of the company? If there isn't does the head surgeon that is mainly responsible for administering or dictating the procedure at the selected hospitals usually get invited on board. What's the incentive ?

  5. #25
    Trials have a principal investigator (P.I.) in charge of the study at each location. (It may or may not be the head surgeon of the hospital or division). They receive the necessary training to carry out the trial in advance along with having the expertise to be selected when the sites are chosen. I don't know how much the companies are charged by the hospital systems participating or what type of pay scale is involved. Some companies do have neurosurgeons on their scientific advisory boards and a few have company positions. Their involvement in the actual studies varies.

    Here is link that explains general studies. LINK
    Last edited by GRAMMY; 04-05-2016 at 09:22 PM.

  6. #26
    Quote Originally Posted by scimike View Post
    Grammy, I have read somewhere that InVivo will give neural stem cells to the first five patients that have received the scaffold. If you know anything about it, thanks.
    I haven't heard that scimike. I believe the patients will not get any additional treatments for awhile anyway. They generally have a time table laid out in advance on how long the company must follow the patients for safety and data. Some of the stem cell trials have patients being followed for 5 years after they were treated. I suppose once their time limit is met, I image they could apply for bioengineered neural stem cell scaffold but I rather doubt they would be accepted because of data difficulty.

  7. #27
    Thanks Grammy. What you say makes sense.

  8. #28
    Quote Originally Posted by scimike View Post
    Thanks Grammy. What you say makes sense.
    Perhaps we can figure out more when InVivo actually announces which company they're going to contract with for cells. (I don't believe they've actually made a public announcement that I'm aware of). There's always the possibility of getting cells at a later time point once the initial participants have all their data recorded. We'll see what the future brings.

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