Does anyone know why this phase I trial takes 7 years? Are all stem cell trials taking this long? Do phase II and III also take 7 years each?
Not sure about 7 years. My understanding is this is a 96 week trial. I had some extensive discussions with the team earlier this year in hopes of becoming number 10 on the trial, but unfortunately was rejected due to one of the exclusion criteria. We were very clear about this being a 96 week trial.
Not sure about 7 years. My understanding is this is a 96 week trial. I had some extensive discussions with the team earlier this year in hopes of becoming number 10 on the trial, but unfortunately was rejected due to one of the exclusion criteria. We were very clear about this being a 96 week trial.
I just saw it and was going to post it but it does not say level of injury. I didn't see any muscle atrophy in the arms or hands post injury so I question it.
Ti
"We must overcome difficulties rather than being overcome by difficulties."
Not sure about 7 years. My understanding is this is a 96 week trial. I had some extensive discussions with the team earlier this year in hopes of becoming number 10 on the trial, but unfortunately was rejected due to one of the exclusion criteria. We were very clear about this being a 96 week trial.
Understood. I think the entire trial, not for each patient, takes 7 (2017-2023) though. And this is just phase I. Wondering how many years from now this could be approved and made available for the majority of the patients.
If you watch the video and read the articles, it very clearly states the guys injury what is C3 - Asia C.
They did say that he was originally diagnosed as Asia A but very shortly after began getting some movement and feeling back.... so he was Asia C before the trial and obviously Asia D (really Asia D++) after the trial.
He started about 1 year post injury and these results shown are at about 3 years post injury.
Look... there are definitely some things to be skeptical about here. For instance their claim that he plateaued after 6 months. That is silly. Anybody that is getting movement back and going from no movement to an Asia C over the first few months ISNT going to Plateau completely at 6 months. With hard work he could have been improving over the next few years or longer... most Asia C injuries can walk to some extent.
They also showed very little about his hands. I'm not sure how debilitated they were. They were hardly mentioned.
So while our group absolutely knows much more about the reality of these injuries than the General Public and have much more to be skeptical about, on some level there are some things to be very hopeful about here.
I just wish they would show more about people's functions before the trial. Instead of showing him on a standing frame with a neck brace on which we all know means nothing 6 months later...
Show him ambulating with a walker. Or on a treadmill. So we can compare what was really going on pre-trial
But I guess that does not make for as compelling a news story...
Another thing I forgot to mention which is interesting. On clinicaltrial it states the inclusion criteria was Asia A or Asia B... yet this person was Asia C.
So.... I don't know what was going on there.
Someone who appears to be Asia A directly after injury from spinal shock who progresses to Asia C in the first few months can potentially have a very high ceiling on progress over the next 2-5 years with hard work...
So I'm not sure what was going on there. Maybe the video / reporter got it wrong. Maybe he was Asia B? Although they did give examples of movement pre trial... so thats auto C.
I don't know. It's great to hear that research is coming along but I'm definitely skeptical about this one at the moment unfortunately.
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