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Thread: XCell-Center Gets Approval by French Health Authorities Conduct trial for chronics

  1. #1

    XCell-Center Gets Approval by French Health Authorities Conduct trial for chronics

    http://www.prnewswire.com/news-relea...-95763719.html


    XCell-Center GmbH Gets Approval by French Health Authorities to Conduct Clinical Trial with Stem Cells for Chronic Spinal Cord Injury

    DUSSELDORF, Germany, June 7 /PRNewswire/ -- XCell-Center GmbH, Europe's leading provider of adult autologous stem cell therapy, announced approval of the first placebo controlled double blind clinical trial in patients with chronic spinal cord injury.
    L'Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), (the French equivalent to the United States Food and Drug Administration) has authorized this multi-centre, phase II/ III clinical study to assess the efficacy and safety of autologous adult stem cell therapy in patients suffering from chronic traumatic spinal cord injury. The clinical trial has also been approved by the Ethics committee and will evaluate 120 patients. The Stem Cells will be processed at XCell-Center's cGMP certified laboratory in Germany, using its proprietary cell processing technology (patent pending).
    Principal Investigator of the Study is Prof Jean Chazal from the University Hospital in Clermont-Ferrand, France.
    Prof. Erik Wolters from the Free University Hospital of Amsterdam, The Netherlands, is the chairman of the Clinical Trial Steering Committee.
    According to Dr. C. Kleinbloesem, CEO XCell-Center GmbH, "We are ready to begin the clinical trial that will mark the beginning of new era to help patients with spinal cord injuries."
    To learn more about XCell-Center and review safety data, please visit:

  2. #2
    But I thought they were already helping thousands. Why waste
    money on a clinical trial if they were once so confident in their
    treatment, they charged people tens of thousands of dollars?

  3. #3
    Senior Member lunasicc42's Avatar
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    I think this is good as the question of their validity can be put to rest
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  4. #4
    Quote Originally Posted by chilacas View Post
    http://www.prnewswire.com/news-relea...-95763719.html


    XCell-Center GmbH Gets Approval by French Health Authorities to Conduct Clinical Trial with Stem Cells for Chronic Spinal Cord Injury

    DUSSELDORF, Germany, June 7 /PRNewswire/ -- XCell-Center GmbH, Europe's leading provider of adult autologous stem cell therapy, announced approval of the first placebo controlled double blind clinical trial in patients with chronic spinal cord injury.
    L'Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), (the French equivalent to the United States Food and Drug Administration) has authorized this multi-centre, phase II/ III clinical study to assess the efficacy and safety of autologous adult stem cell therapy in patients suffering from chronic traumatic spinal cord injury. The clinical trial has also been approved by the Ethics committee and will evaluate 120 patients. The Stem Cells will be processed at XCell-Center's cGMP certified laboratory in Germany, using its proprietary cell processing technology (patent pending).
    Principal Investigator of the Study is Prof Jean Chazal from the University Hospital in Clermont-Ferrand, France.
    Prof. Erik Wolters from the Free University Hospital of Amsterdam, The Netherlands, is the chairman of the Clinical Trial Steering Committee.
    According to Dr. C. Kleinbloesem, CEO XCell-Center GmbH, "We are ready to begin the clinical trial that will mark the beginning of new era to help patients with spinal cord injuries."
    To learn more about XCell-Center and review safety data, please visit:
    I am glad that they are doing this trial. Wise.

  5. #5
    Quote Originally Posted by Buck_Nastier View Post
    But I thought they were already helping thousands. Why waste
    money on a clinical trial if they were once so confident in their
    treatment, they charged people tens of thousands of dollars?
    maybe thats how they funded there trial? Wow, how stupid of them....

  6. #6
    Quote Originally Posted by Eric.S View Post
    maybe thats how they funded there trial? Wow, how stupid of them....
    Eric, it would be not only unethical and against regulations in Europe for them to randomize patients who pay for a treatment to placebo but I suspect that they will not get many volunteers to pay for a 50% change of getting treated. Wise.

  7. #7
    Quote Originally Posted by Wise Young View Post
    Eric, it would be not only unethical and against regulations in Europe for them to randomize patients who pay for a treatment to placebo but I suspect that they will not get many volunteers to pay for a 50% change of getting treated. Wise.
    thats not what im saying. Im saying maybe they used to the money they gained from the unregulated procedures to fund the trials. thats an idea i thought of long ago. use the proceeds from an experimental procedure to fund a clinical trial. you don't have to charge for the trial because you funded the trial with the profits of your experimental procedure.

    its a win win in my opinion because you already pretty much know the outcome of the trial so your lowering the risk of failure (unless your procedure doesn't work) and your legitimizing your procedure to the whole world. In business they call that synergy....

    if your not pretty sure your experimental procedure works I would think your stupid to take it to trial.... If there doing what im thinking then I commend there creativity and efficiency.

  8. #8
    Hi everyone,
    I just read the report file from XCell
    Autologous Stem Cell Transplantation by lumbar puncture:
    A safety Follow-up in 870 Patients
    February 4th, 2009
    Johannes P.J.M de Munter, Director Research and Development
    XCell-Center Cologne and Dusseldorf Germany

    We have:
    XCell-Center evaluates the side effects of a transplantation with autologous stem cells, using a standard Post Treatment Survey. In this paper, 870 patients with a lumbar puncture as procedure for delivery of the stem cells were reviewed for side effects, using the results of the Post Treatment Surveys.
    Another study involved 9 complete spinal cord injury patients with a follow-up of 1 year. They observed major improvements and no side effects. In both studies, MRI’s didn’t show any signs of malignancy.
    Does anyone over here has been involved in the procedure ?..
    Are XCells safely prepared ?..
    870 patients, that's a lot, I could go for that..
    What do you guys think about that ?..
    Thanks
    George

  9. #9
    That's it. I'm going.
    "It's not the despair, I can handle the despair! It's the hope!" - John Cleese

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  10. #10
    Quote Originally Posted by George78 View Post
    Hi everyone,
    I just read the report file from XCell
    Autologous Stem Cell Transplantation by lumbar puncture:
    A safety Follow-up in 870 Patients
    February 4th, 2009
    Johannes P.J.M de Munter, Director Research and Development
    XCell-Center Cologne and Dusseldorf Germany

    We have:

    Does anyone over here has been involved in the procedure ?..
    Are XCells safely prepared ?..
    870 patients, that's a lot, I could go for that..
    What do you guys think about that ?..
    Thanks
    George
    I wonder what major improvements mean? If there were major improvements i'm thinking word would have spread... especially after 800 patients. we'll see what happens....

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