Saturday, August 29, 2015

August Update

It has been a pretty busy last couple of months, starting in late June with a trip to Miami to have my final evaluation to be in a trial at The Miami Project for their first chronic injury trial. I try to stay on top of research, which lead me to read about it and reach out to them to see if I qualified. I was excited to make it through some early qualification forms and pass a couple of initial phone interviews but ultimately they needed an MRI to so see my actual injury site and if it met the size criteria that they had set with the FDA.

An MRI is usually not done after having a spinal cord injury, which is frustrating since it can be helpful to learn about your injury and a requirement when pursuing new treatment trials. This is not done because insurance does not want to pay for it and does not deem it as medically necessary, since it is a pretty expensive imaging technique. So I started calling around pricing MRI’s and was getting most quotes between $1K-2K!  Once I relayed this to Miami, we decided that it might just be best to come down and let them do it at no cost. Unfortunately I would be responsible to pay for travel and accommodations but figured it would almost be a wash by not having to pay for the MRI.

I knew going in that the likelihood of me qualifying was minimal, especially after hearing it could not be bigger than 3 centimeters. Since I would not know unless I tried and that having an MRI would likely be required for any other trial I wanted to try to get into, I decided to make the trip. My father and I decided to make the long drive down to Miami, stopping in Jacksonville, which is about halfway, on both the way down and the way back.  It was a long drive!

The trial I was trying to get into consisted of injecting Schwann Cells into the injury site, along with some exercising and monitoring for a total of 3-4 years. This would be an FDA Phase I trial, which means that it is mostly about safety and while they do monitor and look for functional improvements it is not until phase II and III where they look to optimize the dosage and methods of physical therapy used in the treatment. Since the Schwann cells actually come from my own body, the risks would be limited and since these trials move painfully slow, I decided it was worth trying to get into phase I.
After meeting the research team and discussing a few things, I was taken to have my MRI, which was not the most enjoyable experience. They put me in a tight tube and I was in it for about an hour. I have no idea how they fit some people inside it, since even for me it was a real tight squeeze. It also got hot and uncomfortable in there so I just closed my eyes and dealt with it the best I could.
The next morning we found out that my injury site was a bit over 4 cm, which was too big for the trial. While this was disappointing it was also expected and finding people with thoracic injures like mine that meet the requirements is not easy. Most thoracic injuries come from high impact injuries from things like an auto accidents so finding an injury that small is not common. In fact, one of the research doctors in Miami likened it to searching for a Lithuanian short stop in MLB that bats left and throws right, in other words, there might be one?  Why the FDA would choose to set an inclusion criteria that is so hard to meet is hard to understand. While I know that they seek to strike a balance between safety and progress, I feel that they tend to go a little too conservative, especially for spinal cord injuries, which do not have any proven effective treatments. I have met several people in research that feel the same way.

As disappointing as this was, I knew I had to give it a shot. I was glad to not have much time to dwell on it, since I finally had to be in Louisville at Frazier Rehab for most of July. I left on July 5th with my mother and made the drive to Louisville. What was supposed to be a 7 hour drive turned into a 10, due to July 4th weekend traffic and construction delays. Since I was running behind, I decided to call the extended stay I was scheduled to stay at and let them know I was running late, to which they said was not a problem but when we arrived they gave my room away and the wheelchair would not fit into the bathrooms of the rooms that they had left. So I had to scramble at 9pm and find a place to stay the night and worry about it after my first appointment in the morning.

After my appointment I hit the phone and drove around till I finally found a place just 6 miles from Frazier and for only $39.99 a night. I think I got the manager to take some pity on me and it was not the nicest hotel in the world but not bad. My mother flew back after the first week and I stayed for another 3 weeks for treatment. I had been waiting to go to Louisville for about 15 months but things got delayed far longer than I ever could have imagined. I was there to work with Dr. Susan Harkema, who is behind the implant trial that has been in the news recently. This is one of the most promising things going on in SCI research and something I have been keeping an eye on for a couple of years, which lead me to reach out to her.

If you watched the videos or read the article it is an implant that has allowed people paralyzed from the waist down to be able to stand as well as gain back voluntary movement and significant improvement to some of the body functions impaired by SCI injuries. I have said this before but part of my injury is at the bottom of the cord where it branches out from the long and straight portion, which starts at your brain. I never would have thought this but apparently fixing or repairing a low injury like mine, is much more complex and complicated than a higher injury. So right now the implant is not an option for me, which as you can imagine is pretty frustrating. While I do not have some of the body issues that higher injuries like the ones who have had the implant might have, I continue to be limited by my level of injury when it comes to the trials or potential treatment I seek.
The good news is that they want me to come back for 6 months or so in mid-January to use a prototype device that attempts to excite my nerves and the cord itself. I will be the first to use this device and Dr. Harkema believes that this could lead back to regaining some function, which is what I have been trying to do. I was using a similar device the few weeks I was there and was getting a good response but we need more time and more power to have a better idea of how it will benefit me and others. The hope is that I will know by the end of my next stay if it the treatment will lead to gains and if it something I should try to secure the funds to purchase to continue using at home.

So I am excited about my return there in January and until then I will keep do my home workout routines, working on my foundation, doing some part-time work, and working toward my Masters in Health Care Administration.