obviously regenerating a spinal cord injury is a completely different beast than cloning a hair follicle. and the conditional approval for that kind of proposal earned a lot of controversy but here is the big difference, it's hard to verify whether the stem cell treatment for spinal injuries actually works while it is much easier to verify whether a good hair has been grown, in fact that latter has been done. there is also safety concerns, like when the stem cells are injected into the cord they end up in the blood stream, stem cells in the blood stream can form clots in the lungs and can lead to their collapse. it's quite different than implanting a hair. furthermore those kind of stem cells have never been show to grow fully functional neurons while a fully functional hair follicle, human one, has been grown form stem cells. so the science seems to be a lot easier and far less risk seems to be involved just by the very nature of the procedure
> And finally in no way shape or form do I believe even for one second that they will have completed everything by the end of 2020 leading to a full-fledged unstipulated, unabided market approval, to the point where western countries will observe the data and Subsequently allow it to be released within their own market, Leaving all of us on this fourm a phone call and worst case scenario a decent waiting list away from receiving Dr. Tsuji’s Cellular treatment for new hair follicles in the closest major city to us next year
I think it's fairly obvious that nothing like this will get cleared by the fda in the next 2 decades. we can thank terrorists like george bush for that who had a significant negative impact on stem cells research in the US in the early 2000. but what does it matter? of course tsuji will not be ready by 2020, they will do the trial, if it's successful which I believe it will be based on their confidence and expertise(they do have a rough idea what works and what doesn't, they don't just go into this completely clueless) then there will be the conditional release but they have to still do so many things, make it more efficient in cost, increase their production capabilities, they want to automate the process etc, the actual cloning must be made more affordable, they can work on all this during the conditional period. and even then, we absolutely don't need this to be available in europe or the US. I honestly don't believe that the waiting list will be THAT extreme, I think the pricing will take care of that. imagine how many people have an income world wide that would make them able to afford a 100k treatment? that eliminates a sh*t ton of people. and japan is just a flight anyway, if you are on this forum hoping for tsuji to come out but think it's breaks due to the flight you are insane.
I would be interested in the waiting list thing though, I have no real idea in what dimension the initial demand will be. if we are unlucky this is literally 15 years away for the averae american joe who doesn't have any connections
Do you remember when you admonished me for talking about the rudimentary aspect of a phase 3? Do you ever consider that someone may just use rudimentary examples for people to understand a comparative being made against it? And please, I know that my responses are quite verbose, but that’s because I go through each point that you make and I try and address each one… Which is the proper conduct of a debate, I don’t Cherry pick what to respond to and Shun away from a mistake or something I can’t offer a productive rebuttal too, Please offer me the same courtesy or lets not waste each others time. it is very plain to me that we both want the same thing, and in fact we evidently are in agreement, however I believe you have misinterpreted much of what I have been saying, and in some cases considered citations my own opinion for whatever reason. In regards to a rudimentary example used simply as the basis for a comparative, please I’ve been a quadriplegic for seven years I am painfully aware of the difference and likely far more aware of the work being done on the condition. However, if you are going to quote me on something for example what I said about spinal cord injury research don’t take one small section from my fairly long remarks about the subject matter, and then take said small section out of context to base your rebuttal.
Umbilical Cord blood cells are pluripotent, therefore theoretically they could develop into neural stem cells, but the results on that lacklustre to say the least, you are correct in your assessment in regards to neurogenesis. However what do umbilical cord blood cells Offer: relatively cheap and a pretty immaculate safety profile. Dr. Young used them for that reason, the oral administration of lithium was supposed to help produce Nero genesis, the very intensive functional walking program out of Kumming in conjunction was to help the body utilize neuroplasticity and essentially resprout axons, it actually showed bizarre but beneficial results 75% of patients were able to initiate and start walking with their legs brace along with a large walker. I then went on to the reprogrammed autologous neural stem cells ( initially harvested from bone marrow and then under the brilliance that is Dr. Alhfors re-programmed into neural cells)... blah blah irrelevant. However I went on to talk about two things in relation to spinal injury: subcutaneous epidural stimulator‘s which have been shown to be safe and effective but have lost all momentum, and more pertinently ( in relation to your talk about how some products get through a phase 3 in six months or less) A more advanced noninvasive transcutaneous epidural stimulator, it’s set up and capability of higher frequencies is different but it’s not unlike EMS machines you can buy off Amazon right now ( it’s just far more sophisticated and intricate but no more invasive or dangerous) yet despite a decent showing of efficacy in pilot studies it’s barely moving forward over the last year’s.
There is no comparison to regenerating spinal tissue versus a hair follicle, we are talking about two separate hierarchies of medical research, remember your admonishment on me being rudimentary in regards to the quote on the processes of a phase 3 for most drugs, you feeling the need to point out The difference between regenerating spinal tissue to a hair follicle is the zenith of rudimentary. I merely started on this subject so that I could bring up the epidural stimulator’s specifically the transcutaneous one, it’s undeniable safety relative efficacy to a condition that has no treatment yet it receives no momentum (Most importantly this is just one example, make no mistake this is not uncommon unfortunately), this is the infuriating nature of these regulatory committees, even Japan and their new regulations would likely not benefit Dr. Edgarton’s transcutaneous epidural stimulator, as it is a medical device not a regenerative treatment ( however a caveat, within the two acts they do make reference to medical devices, but the Japanese government is clearly focussed on cellular therapies specifically and likely wants to be on the forefront of genetic therapies as the knowledge in genealogy progresses.) BTW spinal tissue has been shown to be capable of being regenerated within animal models (olfactory stem cells May have done it within a human patient that had a severed spinal cord which they reconnected with a extracted nerve from the ankle before administering the stem cells, in another unfortunate patient these cells have literally grown a nose on a patient’s spinal cord) . Hair follicle regeneration is no walk in the park that is undeniable, yes we both agree in fact it shouldn’t of even had to been said spinal tissue > hair follicle, however you are absolutely correct there is a greater risk administering stem cells to the spinal cord under the derma compared to a mere injection of the scalp, but again that should go without saying, however a transcutaneous stimulator that you just place on the skin that covers the location of the injury site is far less invasive than a scale Injection, and most importantly there is absolutely no chance of and autoimmune rejection to the cells, which can take place even if they are autologous. Dr. Tsuji’s extracted papilla cells and epidermal cells, could be rejected by an unlucky individual after they are extracted they are taken and cultured to create a new hair follicle germ ( mind you he is a Head researcher of one of the most advanced cellular labs in the world, you know these guys are meticulous, but nothing is infallible especially in medicine especially in cellular therapy a new frontier, contamination however unlikely could take place during the process, infections from extractions and various other adverse effects that are beyond my comprehension are possible, also The new hair follicle “germs“ could not take in certain individuals) all of these will lead to the necessity for prolonged patient observation and potentially larger control groups, we can’t pretend that everything will just go perfectly because dr. Tsuji is a genius! Look, by his own admission they ran into a “hurdle“ ( I did not see much specificity on what exactly transpired, probably beyond most of our paygrade anyways) which from what I’ve seen is what prevented them from starting human trials in 2018 as the CEO of Organ laboratories projected, But as many comments stated earlier on in this thread clearly they overcame the issue, so we can hope for the best moving forward… But we must keep in mind that now they are moving into human models . Just because the hair follicles took within mice models doesn’t mean The results will transition The same way in each human patient, it’s happened many times before with cellular based trials, as well as pharmaceuticals. We all have a different genome, when it comes to these kind of assessments of how we react we look at single nucleotide polymorphism‘s of the specific alleles vary between each individual . For example there is a class of antibiotic, and various other medicines that can cause a very rare but serious skin condition known as Steven Johnson syndrome, I know for drugs like modafinil they have identified certain SNP’s to be the likely culprits leading to such a reaction.
Also bush, the troglodyte shut down work on embryonic stem cells, totipotent at a certain stage and of all stem cells the most dangerous. Genrone shut down their research because of this, but the thing is after he made that decision cellular researchers begin to focus more so on adult stem cells: Mesenchymal stem cells, primarily extracted from bone marrow and umbilical cord blood, etc Olfactory cell, neural cells which used to primarily come from the foetus, but now A great researcher can reprogram harvested bone marrow stem cells into autologous neural cells. Without even the slightest bit of polemics all of these cell types are safer than embryonic stem cells ( shown to have the highest proclivity towards becoming cancerous). And now we are looking at things like progenitor cells, oligopotency. Obama lifted those sanctions against embryonic stem cell research and a company bought the rights to Genrones Clinical trial with embryonic stem cells, from what I read they are outmoded now with other work being done with adult stem cells
