Neuronata-R Visit 2 Experience

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We had a very early flight time out of Toronto on December 16th, 2018, so we found a Park/Sleep/Fly package that allowed us to drive there the night before, sleep in a hotel near the airport, and take a pre-dawn shuttle to the airport while leaving our vehicle at the hotel. The parking savings more than paid for the hotel room, and we were both dropped off at the curb without my cousin (the driver) needing to leave me and the luggage while parking. The shuttle bus was NOT wheelchair accessible, but I am still able to tackle steps. Perhaps a wheelchair accessible taxi might be an option in that case. 

For this trip a great friend generously donated first class tickets for our flights. The difference between the economy seats we had on our first flight was extreme- we had our own private cubicles with power adjustable seats that folded completely flat as well as premium meals, drinks, and entertainment options on the seatback TV.  It was slightly more difficult for my cousin to help with meals and tasks that are difficult with my hands, but the opportunity to sleep soundly and comfortably was very welcome.  After touchdown our hospital-arranged taxi brought us to the Best Western Hotel Kukdo located in central Seoul.  The wheelchair accessible room was a little tight with two double beds, but the bathroom was very large with plenty of grab bars. The immediate vicinity of the hotel wasn't very exciting though as it seemed like we were right in the middle of the hardware and lighting fixtures district. We took a stroll around but ended up eating at the hotel buffet for lack of better options. 

The typical Visit 2 schedule requires hospital check-in the day before the second BMA, but I requested same-day check-in so we ended up with a full day to do some sightseeing in the city. We spent the morning at Changdeokgung Palace and its Secret Garden, right in the heart of Seoul. The day was brisk but sunny, and the peaceful surroundings felt far from the massive city that encircles it.  The grounds were well accessible by wheelchair, but the garden had some steep hills that gave my cousin a workout.  We picked up some Christmas presents at the gift shop there and a cup of hot and very sweet persimmon tea.  A taxi brought us to the National Museum of Korea,  where we browsed through the exhibits of ancient Korean artifacts. I would have liked to have seen more 19th and 20th century Korean history so perhaps the National Museum of Korean Contemporary History would have been a better choice. Maybe next trip! After a long day we grabbed takeout and relaxed in the room.  

Day 1

The hospital taxi picked us up from our hotel and after check-in we repeated x-rays (chest only this time, which required me to stand but not get on to the table like during visit 1) and EKG, but not blood tests. The second BMA went significantly better than the first. I had boosted my protein intake (along with iron and calcium supplements) after the first BMA primarily to keep my bone marrow from getting even more depleted, but I hadn't expected to actually improve it in only three weeks. Apparently that is all it took because the doctor said that both the volume and quality were significantly improved, and he needed to go in at only one location. My 6 hours on the rock were also more comfortable, presumably due to less trauma to the area. 

While I was resting Dr. Kim came by for a visit, and he mentioned that a paper he co-authored (Intrathecal Stem Cells for Amyotrophic Lateral Sclerosis) was recently recognized. A summary of the paper and its recognition is here.  It is only after later reviewing this article that I caught that the Phase 2 clinical trial included a control group, but it was NOT a placebo-controlled control group. The recognition article rightly points out the ethical concerns about subjecting clinical trial control group participants to highly invasive placebo procedures, but the fact remains that it is the best method to control for treatment bias, where those patients who believe that they are receiving treatment consistently report better results even if they aren't receiving any treatment at all. BrainStorm chose to incorporate sham injections in its Phase 3 trial which will result in more reliable data, but it requires a lot from the placebo group for absolutely zero benefit, as there doesn't appear to be any plan to offer them any treatment access outside of the trial in return. 

We also discussed the upcoming Neuronata-R clinical trial he is arranging. This trial will involve 200 Korean patients at three sites in Seoul, with the primary goal being to determine whether repeated doses of Neuronata-R are effective, while involving a larger population of patients than the previous Phase 2 study, which had 72. This study will have three phases, with part A being a typical placebo-controlled double-blind single treatment cycle (two injections) after a brief lead-in period, followed by a part B where all participants get a second treatment cycle, and finished by a part C monitoring phase. Dr. Kim expressed to me how important it was for him ethically that any trial he is involved with gives an opportunity for those who initially received the placebo to eventually get the actual treatment, even if that data is not included in the trial results. This obviously differs from BrainStorm's approach, but perhaps is the best compromise for placebo controls that require highly invasive procedures.   

Day 2

Typically the same doctor does all three procedures on a patient, but due to an academic conflict I had a new doctor for the CSF collection. He nailed it though, and got my fluid at the first site he chose on my difficult spine. I told him that he could give my LP pro doctor at MGH a run for her money!  The collection was done in the room as I was curled on my side, similar to how the injections were done in the BrainStorm trial. I had to lay on my back for 6 hours following the procedure but not on a rock like after the BMA. I had no headache or major pain. 

Day 3

A representative from Corestem stopped by to show a video presentation on her tablet. It was a PowerPoint-style slide deck that combined photos from my BMA procedure the previous month and of vials labeled with my name with generic photos of the Corestem manufacturing process. We weren't permitted to record this presentation as it contains proprietary information, but it built my confidence in the company that they took the time and care to document my own specific stem cells at various steps during the process. From the approximately 300,000 stem cells they gathered from my bone marrow they were able to grow 80,000,000 in one month. 

Later that day the injection was made, also in the room, again curled up on my side. This time the doctor who performed my BMA two days earlier did the procedure, but he had a little trouble getting the needle into my CSF with what he called sclerosis. He got to my CSF on the third attempt after switching to between vertebrae L1 and L2 on my spine. I had a similar difficulty with my first injection in the BrainStorm trial but after I gave the doctors at MGH a copy of my lumbar MRI on DVD the subsequent injections went more smoothly. I did the same here so hopefully injection #2 will as well. 

Immediately after the injection a vibrating vest was put on me and a wedge was put under my lower back and legs to help the newly-injected cells distribute up the length of my spine. Four of these vests had apparently been donated by a previous patient to make this process easier, as it previously required the caregiver to use a massage wand for 4 hours after the procedure. I kept the vest on for 2 hours while my caregiver simultaneously used the massage wand on my hips, alternating every 15 minutes.  I remained on my back for an additional 4 hours, and had only minor discomfort. That evening I didn't sleep well and by morning I realized I had a fever, which peaked at 100.4F (38C). I took acetaminophen (that I had brought with me) and within about 4 hours my temperature had returned to normal and I felt comfortable enough to be discharged one day ahead of schedule. I wouldn't plan a return flight based on an early discharge but it was a nice surprise- certainly more comfortable and much less expensive than another night in the hospital. 

The hospital revised our return taxi ride to go to the Days Hotel in Incheon rather than direct to the airport the next day as originally planned.  We took a walk around Incheon and had a nice dinner at the hotel (bulgogi pizza with octopus ink-dyed crust). After that we called it a week. 

After a satisfying breakfast at the hotel we left for the airport early to take advantage of the lounge amenities that our premium tickets gave us access to. We were a little bit too early, however, as the check-in desk for our flight didn't open until 3 hours before our flight and the lounge was on the other side of the security screening area. After making a few laps around the terminal we were finally able to check in (again using the priority lane reserved for wheelchair users) and proceeded on our way.  We enjoyed some food and drink in the lounge and then checked in at the gate, where we were the first to board the plane. By informing the airline of my wheelchair needs early, not only will they have a team of two ready to transfer you into an aisle wheelchair, they will also try and get your seat adjacent to a bulkhead for the shortest distance to the restroom. It ended up being only about four regular steps from my seat (equal to about 30 ALS shuffle steps) so I ended up just holding on to my cousin and walking. 

After a delicious dinner both my cousin and I slept the majority of the flight home.  When I awoke I thought I'd slept about 4 hours, but it turned out to be closer to 8! Everything went well until the last possible opportunity. After taking the shuttle to the hotel where our car was, we did not have my wheelchair.  The shuttle driver had assumed that my wheelchair belonged to the airport and left it at the curb!  Luckily it was still there when we drove back, but we won't make that mistake again. After another few hours of driving we were back home just in time for Christmas Eve the next day.