Quote Originally Posted by KyleP2112 View Post
The posts on here about the trial for chronic SCI was interesting...hopefully progress continues to be made.

Dr. Young - Thank you for your hard work. Here's a question. Do you think chronic injuries that are near the breathing control center of the spinal cord will be especially hard to address?

As my physiatrist said to me during an appt., "the last thing you need is to end up on a ventilator if something unexpected happens after cells are injected"...
Because of the way we are injecting the cells into the spinal cord, i.e. above and below the injury site, we excluded patients who are C4 or higher from the study. The phrenic nucleus is located at C3-C4. We didn't want to inject cells into the spinal cord at C3. At the present, we are finding that injection of up to 16 µliters of cells into the dorsal root entry zone does not seem to be producing lasting neurological deficits above the injury site.

If the phase III trial shows beneficial effects of the treatment is large cohorts of patients with cervical spinal cord injury, we are planning a trial to transplant the cells into the injury site and below the injury site (rather than above and below the injury site) in subjects that are C4 or higher. The risk vs. benefit ratio is too high until we have more evidence that the treatment is beneficial and safe.

The planned phase III trial will compare untethering surgery alone with untethering surgery plus cell transplants. The trial will tell us whether or not the untethering surgery alone is beneficial in chronic spinal cord injury. To date, having seen some patients who have shown benefit from untethering surgery alone, I don't think that it is dangerous to expose the spinal cord and untether the spinal cord, even in high cervical spinal cord injuries. The operation of course needs to be done by an experienced and skilled neurosurgeon.