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Thread: Clinical Trials

  1. #481
    Quote Originally Posted by jhorn4012 View Post
    I received email from stemcellsatombomb (Dennis) and he has all of his immigration paperwork completed and is on his way to Switzerland for clinical trial and the family will be giving updates of his condition after he receives whatever he will be getting in clinical trial. I guess the family doesn't realize being in a clinical trial may mean no info given to public source. But that didn't stop the student in Georgia from releasing to the local news he was the first person to receive embryonic stem cell.
    The restrictions are about releasing details of the procedure. There is no restriction on stating you were in the trial although Geron would prefer they did not do that.

  2. #482
    Quote Originally Posted by jhorn4012 View Post
    I found this from u2fp.org site and the following url: http://clinicaltrials.gov/ct2/show/N...1231893&rank=1

    My question is will this be something that will exclude chronics that have metal discs replacing SCI?
    jhorn,

    Many of the trials require current MRI scans of the spinal cord. We required this also of patients in the ChinaSCINet CN102B trial and had to turn down some patients because of this. Much depends on the metal that is put in and whether it has any iron/steel in the metal. MRI is affected by iron and other paramagnetic materials. Paramagnetic means materials that are affected by magnet fields. http://en.wikipedia.org/wiki/Paramagnetism

    We got permission of our spinal cord injury investigators to waive the requirement for current MRI scans as the requirement for entry into the trial. Some doctors may not be willing to do this because they want to make sure that the MRI scan shows what they are operating on and they don't want to have any surprises when they operate, such as a large syringomyelic cyst or disc compressing the spinal cord.

    On the other hand, even our current neurosurgeons are feeling sufficiently comfortable with the procedure that they are willing to considering doing the surgery without having a clear MRI of the injury site beforehand. By the way, the presence of metallic plates and screws does not rule out a CT scan and clear images of the bone and spinal canal. Needless to say, it would be better to have an MRI.

    Wise.

  3. #483

    Question MRIs and Titanium

    Quote Originally Posted by Wise Young View Post
    jhorn,

    Many of the trials require current MRI scans of the spinal cord. We required this also of patients in the ChinaSCINet CN102B trial and had to turn down some patients because of this. Much depends on the metal that is put in and whether it has any iron/steel in the metal. MRI is affected by iron and other paramagnetic materials. Paramagnetic means materials that are affected by magnet fields. http://en.wikipedia.org/wiki/Paramagnetism

    We got permission of our spinal cord injury investigators to waive the requirement for current MRI scans as the requirement for entry into the trial. Some doctors may not be willing to do this because they want to make sure that the MRI scan shows what they are operating on and they don't want to have any surprises when they operate, such as a large syringomyelic cyst or disc compressing the spinal cord.

    On the other hand, even our current neurosurgeons are feeling sufficiently comfortable with the procedure that they are willing to considering doing the surgery without having a clear MRI of the injury site beforehand. By the way, the presence of metallic plates and screws does not rule out a CT scan and clear images of the bone and spinal canal. Needless to say, it would be better to have an MRI.

    Wise.
    Thank you Dr.Young,
    I have heard mixed views on MRIs and titanium. All doctors said in Texas is "NO" because they are not sure what is metal content of screws and netting that were used in corpectomy.
    I believe I have all that info from neurosurgeon's report (which had been received by Baylor doctors before we flew in) during the procedure and notes made before/during and after when they removed head traction and replaced with a neck collar after surgery to keep her from moving her neck from side to side. Last year we had a CT scan done and everything according to Baylor dr. looked ok.
    Aggie Mom 2007

  4. #484

    Wink Jockey's Clinical Trial

    Quote Originally Posted by c473s View Post
    The restrictions are about releasing details of the procedure. There is no restriction on stating you were in the trial although Geron would prefer they did not do that.
    c473s:
    I will post when I receive any info from family through Dennis T.
    Aggie Mom 2007

  5. #485
    Hi Dr Wise:

    we met in Phoenix, AZ in the last "Learning 2 Walk" seminar. I have an 11 year old son with incomplete SCI whose had a chronic damage for the last 3 years. You mentioned that Shriner's Philadelphia was going to start some "Stem Cell Clinical Trials" hopefully this year. Could you expand some more on which types of trials and how are things going with these trials, in case they've started already?

    Also, how do these trials compare to the "Autologous Stem Cells for Spinal Cord Injury (SCI) in Children" being recruited in Houston right now?

    Thanks
    Last edited by Rivera; 07-09-2011 at 03:58 PM. Reason: want to know difference between trials

  6. #486

    Smile

    Quote Originally Posted by Rivera View Post
    Hi Dr Wise:

    we met in Phoenix, AZ in the last "Learning 2 Walk" seminar. I have an 11 year old son with incomplete SCI whose had a chronic damage for the last 3 years. You mentioned that Shriner's Philadelphia was going to start some "Stem Cell Clinical Trials" hopefully this year. Could you expand some more on which types of trials and how are things going with these trials, in case they've started already?

    Also, how do these trials compare to the "Autologous Stem Cells for Spinal Cord Injury (SCI) in Children" being recruited in Houston right now?

    Thanks
    Thanks Grammy, I hope Dr Wise remembers us. I'll be waiting for your answer

  7. #487
    Quote Originally Posted by Rivera View Post
    Hi Dr Wise:

    we met in Phoenix, AZ in the last "Learning 2 Walk" seminar. I have an 11 year old son with incomplete SCI whose had a chronic damage for the last 3 years. You mentioned that Shriner's Philadelphia was going to start some "Stem Cell Clinical Trials" hopefully this year. Could you expand some more on which types of trials and how are things going with these trials, in case they've started already?

    Also, how do these trials compare to the "Autologous Stem Cells for Spinal Cord Injury (SCI) in Children" being recruited in Houston right now?

    Thanks
    Rivers,

    We are pushing hard to get the phase 2 trials finished in Hong Kong and China because the applications for trials in the U.S. depends on the data that we get from the trials in Hong Kong and China.

    In terms of trials in the U.S., we are still aiming for starting a phase 2 trial in Brackenridge in early 2012, a phase 3 trial in other centers in the U.S. in mid-2012, and a phase 2 trial for kids in late 2012. This is for umbilical cord blood and lithium.

    Wise.

    Wise.

  8. #488
    Thanks Wise for keeping us so up to date.

    Does finishing phase 2 trials mean that there has to have been atleast some return of sensation or function because phase 2 is for efficacy, if only a tiny amount?

  9. #489
    By the way those possible dates are fantastic and I'm sure everyone on carecure appreciates the work you and the others do to keep these clinical trials going.

  10. #490
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    yes, much appreciated wise
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