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Thread: Screening for clinical trial enrollment begins

  1. #1

    Screening for clinical trial enrollment begins

    Hi All
    I would like to share a very interesting experience I have just gone through.
    As many of you know already Profs Armin Curt is currently recruiting candidates for the fetal cell stage 1 and 2 combined clinical trial to be held in Bulgrast Zurich Switzerland, 3 candidates from each Asia scale are to be chosen. I had applied in March, filled in the consent form and sent them all my clinical data. I was invited to attend a screening process; all expenses were paid by the sponsor. Any candidate may also drop out or terminate the trial at will at any stage too no pressure at all, this is also fully explained in the trial protocol approved by the Swiss medical authorities.
    I will not venture into the exclusion criteria as it is well published in their website but I can tell you of my experience. The trial protocol is very strict and the amount of seriousness and dedication shown has simply amazed me. Bulgrast university hospital is a state of the art centre dedicated to paraplegia I have yet to see.
    To cut a long story short after a whole week of very extensive MRI, blood tests, electrical stimulation, physiological exams, and so many others tests I can’t remember it was concluded that I had a pressure sore stage 2 which was infected with MRSA, a fistula to the bone showed up in the MRI too. All this I had obtained from my local hospital, so you may know how angry I am about local care.
    I knew the sore might cause problems during immune suppression however I was unaware of the MRSA and fistula. Alas I did not satisfy the criteria. If successful the cell implantation would have been carried out on the 30th of August as my one year into injury was fast approaching and protocol had to be observed. Another Asia A T2 complete candidate from Ireland was also excluded due to Conus trouble noted during the MRI. Although disappointed this reflects the seriousness of the study team.
    Meeting the trail team was such an experience. I would personally like to thank Profs Curt, Dr Marezion Axel study co coordinator. And Edith Manual the study nurse who were our personal attendants. Dr Curt had gone to great lengths in explaining the trial protocol, and the study process. Cells were used on rodents and primates which proved to be both safe. Efficacy was mostly noted on rats. The cells were also implanted into human brains, although the subjects died due to their terminal condition the cells did not form any terratomas, and engrafted well. Yes when I asked about a risk assessment Dr Curt was positive about safety but could give no guarantees. As to efficacy this has yet to be studied further but signs look promising if not Palo Alto would not sponsor the study. May I conclude that if any of you CC members would like to commit and satisfy the exclusion criteria I would highly recommend the enrollment in this trial.

    Peterf

  2. #2
    Senior Member lunasicc42's Avatar
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  3. #3
    Yes i was supposed to be their first candidate it is for chronic SCI not past a year of injury i just came back from Switzerland yesterday
    Last edited by peterf; 08-26-2011 at 06:28 PM.

  4. #4
    Quote Originally Posted by peterf View Post
    Hi All
    I would like to share a very interesting experience I have just gone through.
    As many of you know already Profs Armin Curt is currently recruiting candidates for the fetal cell stage 1 and 2 combined clinical trial to be held in Bulgrast Zurich Switzerland, 3 candidates from each Asia scale are to be chosen. I had applied in March, filled in the consent form and sent them all my clinical data. I was invited to attend a screening process; all expenses were paid by the sponsor. Any candidate may also drop out or terminate the trial at will at any stage too no pressure at all, this is also fully explained in the trial protocol approved by the Swiss medical authorities.
    I will not venture into the exclusion criteria as it is well published in their website but I can tell you of my experience. The trial protocol is very strict and the amount of seriousness and dedication shown has simply amazed me. Bulgrast university hospital is a state of the art centre dedicated to paraplegia I have yet to see.
    To cut a long story short after a whole week of very extensive MRI, blood tests, electrical stimulation, physiological exams, and so many others tests I can’t remember it was concluded that I had a pressure sore stage 2 which was infected with MRSA, a fistula to the bone showed up in the MRI too. All this I had obtained from my local hospital, so you may know how angry I am about local care.
    I knew the sore might cause problems during immune suppression however I was unaware of the MRSA and fistula. Alas I did not satisfy the criteria. If successful the cell implantation would have been carried out on the 30th of August as my one year into injury was fast approaching and protocol had to be observed. Another Asia A T2 complete candidate from Ireland was also excluded due to Conus trouble noted during the MRI. Although disappointed this reflects the seriousness of the study team.
    Meeting the trail team was such an experience. I would personally like to thank Profs Curt, Dr Marezion Axel study co coordinator. And Edith Manual the study nurse who were our personal attendants. Dr Curt had gone to great lengths in explaining the trial protocol, and the study process. Cells were used on rodents and primates which proved to be both safe. Efficacy was mostly noted on rats. The cells were also implanted into human brains, although the subjects died due to their terminal condition the cells did not form any terratomas, and engrafted well. Yes when I asked about a risk assessment Dr Curt was positive about safety but could give no guarantees. As to efficacy this has yet to be studied further but signs look promising if not Palo Alto would not sponsor the study. May I conclude that if any of you CC members would like to commit and satisfy the exclusion criteria I would highly recommend the enrollment in this trial.

    Peterf
    Thanks for reporting.
    I had the opportunity to meet Dr. Armin Curt a few months ago and I have been impressed positively by him as you are reporting.
    Let's hope the trial will turn out to be safe... and effective too!
    In God we trust; all others bring data. - Edwards Deming

  5. #5
    Thank you for this interesting report.
    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

  6. #6
    @peterf I'm sorry that things just didn't work out correctly for you to be in that trial. Hopefully you can get the problems resolved right away. I know how disappointed you must be feeling.

  7. #7
    Same for me, although I didn't get as far as you as far as being flown out and tested.
    "We have been going very carefully through the provided material regarding the spinal cord injury of you . Based on this information and due to the very detailed regulatory constraints, we are unable to include you into the study.
    In this trial, one must be transplanted within one year after the accident; due to an unexpected delay in our study we can not meet this deadline in your case.
    We are very sorry for this final decision but it is necessary that we follow the regulations provided by Swiss authorities. Please accept our sincere greetings and best wishes for you.
    Our best wishes for you and thanks for all your good work.

    Sincerely greetings,

    Edith Manuel Study Nurse"

  8. #8
    Quote Originally Posted by JohnMarz View Post
    Same for me, although I didn't get as far as you as far as being flown out and tested.
    "We have been going very carefully through the provided material regarding the spinal cord injury of you . Based on this information and due to the very detailed regulatory constraints, we are unable to include you into the study.
    In this trial, one must be transplanted within one year after the accident; due to an unexpected delay in our study we can not meet this deadline in your case.
    We are very sorry for this final decision but it is necessary that we follow the regulations provided by Swiss authorities. Please accept our sincere greetings and best wishes for you.
    Our best wishes for you and thanks for all your good work.

    Sincerely greetings,

    Edith Manuel Study Nurse"
    i got the same exact email.

  9. #9
    Disappointed yes but not regretful. I would like to advise members that enrolling for a clinical study should be given serious thought and a lot of commitment. After all it is a four year study I don’t think it would be fair to opt out, half way in. the protocol is designed to safeguard candidates rights and safety and very fair indeed. One must also appreciate the huge amount of expenses incurred by the study team sponsor in carrying out such rigorus tests, treatments, flights, food accommodation ect... I was also allowed to bring along with me another person for company everything being paid by the sponsor but no regrets as I was fully committed. As the very time consuming approval from the Swiss regulatory body has been settled, the only issue remaining is finding candidates that can pass the exclusion criteria. I wish them well.

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