GreaseLightning, I've worked for Wise for nine years, so I'll give some backround.
Download the PDF of the published paper from the trials in Hong Kong and Kunming- https://journals.sagepub.com/doi/10....6368916X691411
If you look at the graph on pg 1930 (Kunming Trial) it gives the ages of the 20 participants, under that, how many years they have been injured. The range was 2 to 20 years post-injury, and there was no difference in recovery. All of these subjects received the 6-6-6 training.
If you look at the results of the first trial in Hong Kong (8 subjects/pg 1930), you will see a major difference, none had substantial recovery. This group did not do 6-6-6.
You asked, why 6-6-6?
Chinese neurosurgeon, Zhu Hui, began the 6-6-6 walking program many years ago, at the SCI Military Hospital in Kunming, China. Wise met her while he was there organizing ChinaSCINet. He was very impressed by the recoveryof these patients and decided to make it part of the trial. I visited there several years ago, very impressive.
We learned from the Hong Kong/Kunming trials, that without intensive training, the participants don't recover. Is 6-6-6 necessary to recover? We don't know. Are there less time consuming ways to exercise and get the same/better results, probably. We first need to confirm that this therapy is effective before we radically change any part of it. It is very possible that the cells + transcutaneous stimulation could be more effective that 6-6-6.
After the trial subjects are operated on, this therapy will be available for expanded compassionate use. Anyone can apply to the FDA to have it done, unfortunately, you would have to pay the cost, about 200K. After the trial is complete, Wise plans to hold trials for groups that aren't in the inclusion criteria. Those under the age of 17 and over 65, and those who have injuries above C5. There is a lot to do, we need more clinical trials in the US.
I walk every week and I still improve steadily after 4 years. Granted, at this rate I'll be walking independently sometime around the year 2335, but one can make progress.
More importantly, reconnected axons without training are just like those of a newborn - the brain won't know how to use them without extensive training.
One thing I'm curious about Jim, since we program our neural net as a baby by flailing, then crawling, then walking, why don't we try to replicate this with stem cell patients? Start with only mat work until the brain figures out what the new connections can do, etc.
T3 complete since Sept 2015.
Hey Mize, I believe some rehab places do begin with crawling. I don't think this is necessary though because walking is programmed into the spinal cord via the Central Pattern Generator. It really is like a reflex. Once you start, the body knows what to do. Of course, after SCI it takes much repetition. I saw it when I visited Kunming, and also in the videos of those in the trial. We don't need our brains to walk. When you cut a chicken's head off, it will run around until it runs out of blood.
Those that developed the 6-6-6 walking protocol don't believe in using any orthosis, because if you disrupt the natural movement, it prevents the CPG from cycling.
If you received cells, you would might walk better. We are planning to do incompletes also.
Hi Jim,
Any idea of when more details of the protocol to be used for the walking in the trials will be available?
Hi Jim
Do you if foreign people can apply to the Fda for compassionate use?
Do you know if standing is also controlled by the CPG like walking, I mean people who have already received the therapy can stand alone?
Thanks by advance
Hi Naty,
I am told that anyone can apply for the trial. The surgeons choose who will be in the trial. A critical part is returning for follow up exams at 1 and 2 years. If they are concerned you may not come back for these, will be less likely to choose you. (Just my thought.)
As you may have heard, it is tougher to get into the US these days. Here's what you would need- https://clinicalcenter.nih.gov/parti...info/visa.html
The goal at the end of the 1st 2 weeks of therapy (post-op) is to stand 6 hrs per day. You start off in a standing frame, some at the end are able to stand with minimal or no assistance at all. The CPG is not involved.
Thanks Jim,
I think i don’t understand what is compassionate use!
I was thinking it was apart from the trial, something more commercial.
Can you explain me please
Thanks
They took 20 individuals with "chronic complete" injuries and 15 were walking after the trial? Nobody thought videoing this would be significant? I find this extremely hard to believe. None of the 15 people were stoked enough to post a personal vid on youtube after? In this day and age? Come on man...
I've seen the videos, read the published paper- https://journals.sagepub.com/doi/10....6368916X691411