SCINetUSA Website

[Wise Young]

Originally Posted by peterf

Dear Dr wise

Can you please tell us if candidates who have a spinal cage inserted into the vertebre, existing pressure sores and acute spinal stenosis are part of the exclusion criteria for the chinasci trials

These are not part of the exclusion criteria but the investigators are charged with the responsibility of excluding any patients that they think may not be suitable for the risks of the surgery and clinical trial. The trial in Hong Kong requires that a reasonably clear MRI scan be obtained of the injury site and substantial effort is made to obtain a diffusion-tensor image of the injury site. The trial in Kunming will not require an MRI.

I don't know whether MRI will be part of the requirement for the SCINetUSA trials. The presence of a cage may interfere with the MRI. This decision will be made by the investigators. We originally required an MRI before and after the procedure so that complications such as hemorrhage can be detected. However, hemorrhage can be detected with CT scans as well and if the surgeons are comfortable with just CT, the trial can go ahead without clear MRI's. This was the decision made by the doctors in Kunming.

Regarding decubiti, this is also up to the surgeons. Of course, if the pressure sore is infected and the person has a fever or other signs of an infection, this would not be good and it is unlikely that the surgeon will accept a person with an infection. However, if the decubitus is small, uninfected, and healing, I don't think that this would necessarily prevent participation in the trial. This is up to the doctor.

Regarding spinal stenosis, much depends on the nature and extent of the stenosis, whether the spinal cord is compressed. If the spinal cord is compressed, we will probably exclude the patient from the trial because we would not be able to tell whether the decompression or the cell transplants resulted in any recovery. The surgeon may choose to decompress the patient before the transplantation. These decisions have not yet been made.

Wise.

[peterf]

Tks Dr Wise for your very quick reply
Just love to read your postings

Your info about trial criteria, metal spinal cages and MRI was very interesting, now i know it's better to have a radiolucent cage inserted for MRI purposes

[catlikekg]

Dr. Young or anyone.. Do we know if it makes a difference what grade the Titanium cage is? I was under the impresion it is easier to see through the different grades of metals. Thank you..

[Wise Young]

Originally Posted by catlikekg

Dr. Young or anyone.. Do we know if it makes a difference what grade the Titanium cage is? I was under the impresion it is easier to see through the different grades of metals. Thank you..

If there is iron in the cage, that interferes more with MRI. Pure titanium does not interfere but titanium is quite brittle and many manufacturers put in different elements to improve the flexibility of the metal. Often, it is impossible to tell until you actually put a patient into an MRI machine. We had one patient who had metal both in front and to the back of the injury site and we were able to visualize the spinal cord and obtain diffusion tensor images from the spinal cord. In China, most of the rods, screws, and other devices have steel in them and we often cannot even see the spinal cord because of the interference.

Wise.

[peterf]

I have read that PEEK or carbon fibre is now being used instead of titanium

[catlikekg]

Dr. Young if upon operation the operating Dr.s find some hardware may be better off extracted will they do so? Also will the Dr.s goals be to remove any bonefragments or stuborn scar tissue? Thank you

[catlikekg]

I have a good feeling about the very near future for us all. Dr. Young thank you

[Wise Young]

Originally Posted by catlikekg

Dr. Young if upon operation the operating Dr.s find some hardware may be better off extracted will they do so? Also will the Dr.s goals be to remove any bonefragments or stuborn scar tissue? Thank you

It will be up to the doctor. Our position is that no hardware should be removed just for the trial. If your doctor believes that removing the hardware would be beneficial to you, it can be removed before the trial.

Wise.

[Barrington314mx]

still on track for early 2012 start date? by my calculations, 2012 is right around the corner.

[Barrington314mx]

wise young, can you give us some update on this coming trial? you had said early 2012 and now ive read where you say "later in 2012". whats going on?