Well... I will love anything that diminishes my tinnitusForget bimodal stimulation. We absolutely want regenerative medicine. Besides FX-322 may even beat bimodal to market. Unless the NPCs foil us.
Well... I will love anything that diminishes my tinnitusForget bimodal stimulation. We absolutely want regenerative medicine. Besides FX-322 may even beat bimodal to market. Unless the NPCs foil us.
They'll worked better than dead ones dood. What have I done to offend you that you blanket ignore me? I upvote your comments and basically agree with most of the things you say.Will regenerated hair cells work just as good as the natural ones, yes or no, or we don't know?
Do birds with regenerated hair cells have natural hearing or does it come back lower quality?
Part of the FX-322 patent states that they have a method to replicate the rosette pattern of natural hair cells.Hair cells won't be perfect. Problem can be that inner hair cells that should be oval, will be probably V-shaped, like outer hair cells.
Moreover problem can be the length of inner hair cells from their roof.
"In summary, mammalian inner ears contain several HC subtypes that vary in their morphology and organization within and between different sensory epithelia and species. Current attempts to generate new HCs have thus far yielded only vHC types; however, these vHCs will not function in the OC due to presence of kinocilia and stereocilia organization and will thus not be able to restore their lost hearing at th[e needed sensitivity. Understanding the differential molecular evolution and development leading to HC heterogeneity may lend insights into the unique processes that result in the formation of the correct HC subtype in the right position with the proper polarity essential for function, including connection of HCs to their central targets by afferents."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092489/
I'll believe it when I see it!Once again Decibel hasn't announced anything but they are working on it.
Where did you find that? I've been looking everywhere.Part of the FX-322 patent states that they have a method to replicate the rosette pattern of natural hair cells.
The patent for FX-322.Where did you find that? I've been looking everywhere.
It literally comes down to the ATA over the years (till now) completely isolating tinnitus from related conditions and treating it like it's a completely separate condition of its own right. That's why little progress was made until new research came a long.The patent for FX-322.
https://patents.google.com/patent/US9968615B2/en
"In one embodiment of the present disclosure, the cell density of hair cells in a cochlear cell population is expanded in a manner that maintains, or even establishes, the rosette pattern characteristic of cochlear epithelia."
I cannot possible understand why people on this forum that have NIHL and ototoxicity induced hearing loss aren't intensely focused on this drug. There's far more interest in bimodal stimulation, which may take longer to come out and isn't a cure which I cannot comprehend. This drug doesn't just grow cells, it regenerates the entire system.
I've even been accused of being "too transfixed" on this drug. And I'm pretty sure the person or people that believe that haven't looked at all the information like I have either.
Everyone that has naysayed me about this states "we don't even know if it's going to work", which is wrong because it's already been shown to work in mice and ex vivo in human cochlea explants. So the only impediment is actually getting the drug through the round window membrane in the cochlea, and if it can get into that of a mouse, then it surely will get into a human's, as it is the same drug and a human's round window membrane is larger.
All I am saying is that there is going to be knowledge about the efficacy of this drug by December and that we should push to get it, organize our efforts to get the FDA to classify this drug under the Right to Try laws, and I'm getting pushback about this. There has not been one good argument put forth to me as to why we shouldn't.
Yes, this forum would be a great source of volunteers, I for sure would enroll!I´m daydreaming FX will contact this forum and ask for participants for their next phase.
No way. This will be legitimate.I hope that the day it is commercialized, FX-322 has its legitimacy guaranteed. This invisible condition lends itself to scams.
I would not be surprised to receive an injection of water. lol
Do we know anyone who is now involved in this trial? Any timeframe on this one?No way. This will be legitimate.
Results of Phase 1.5 are scheduled to be reported in December and Phase 2 will start in early to mid 2019.Do we know anyone who is now involved in this trial? Any timeframe on this one?
What does this mean for Frequency Therapeutics, is this their results?Hair cells won't be perfect. Problem can be that inner hair cells that should be oval, will be probably V-shaped, like outer hair cells.
Moreover problem can be the length of inner hair cells from their roof.
"In summary, mammalian inner ears contain several HC subtypes that vary in their morphology and organization within and between different sensory epithelia and species. Current attempts to generate new HCs have thus far yielded only vHC types; however, these vHCs will not function in the OC due to presence of kinocilia and stereocilia organization and will thus not be able to restore their lost hearing at the needed sensitivity. Understanding the differential molecular evolution and development leading to HC heterogeneity may lend insights into the unique processes that result in the formation of the correct HC subtype in the right position with the proper polarity essential for function, including connection of HCs to their central targets by afferents."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092489/
Results of Phase 1.5 are scheduled to be reported in December and Phase 2 will start in early to mid 2019.
For accurate, more isolated results It would be insane to start out with 50 subjects, especially if it's a drug treatment.Any idea why they are only using 24 patients in this trial? That doesn't instill me with confidence.
Why do you say the first part? And yes, you have to be a US citizen.I guess having a hearing loss at 8 kHz and a huge one at 12 kHz would put one out of any phase 2 I guess. Also hmm guess you need to be US citizen?
I couldn't help myself. I really couldn't lol. I got lonely.@katri, what are you doing here!?!?! Lol JK!
Any idea why they are only using 24 patients in this trial? That doesn't instill me with confidence.
Why do you say the first part? And yes, you have to be a US citizen.
That's all they need. Probably because they know it works.Any idea why they are only using 24 patients in this trial? That doesn't instill me with confidence.
You have the optimism that this forum needs. You keep hopes high!That's all they need. Probably because they know it works.
It's not blind optimism either. I am very sure, along with @Contrast, that if your tinnitus was the result of NIHL and that fixing that will fix tinnitus. The class of drugs used in FX-322 have been proven to restore hearing in deafened mice. FX-322 doesn't just regrow hair cells either, it regenerates the nerves. Who cares about the nerves anyway? The end result is restoring hearing, which has been demonstrated in mice.You have the optimism that this forum needs. You keep hopes high!
It's not blind optimism either. I am very sure, along with @Contrast, that if your tinnitus was the result of NIHL and that fixing that will fix tinnitus. The class of drugs used in FX-322 have been proven to restore hearing in deafened mice. FX-322 doesn't just regrow hair cells either, it regenerates the nerves. Who cares about the nerves anyway? The end result is restoring hearing, which has been demonstrated in mice.
The drug has to enter the cochlea through the round window membrane, which it did for the mice, humans have larger round window membranes so it's like throwing a basketball into a bigger hoop, it's easier. They have also shown that it regenerates cochleas that are damaged from ototoxic drugs.
Logic:
1. Many of us have tinnitus that started right when we were exposed to noise.
2. That means that the mechanical noise damage caused our tinnitus. It didn't just coincidentally start like that for all of us here with NIHL. Do not argue this point unless you want to look dumb.
3. Restoring hearing will probably, I think definitely, stop tinnitus.
4. They have restored the hearing of deafened mice.
5. They are testing these methods on humans right now.
6. The drug is safe in humans per phase 1 endpoints.
7. They will know by December if not already, if it works.
8. All of us with ototoxic damage and NIHL should be intensely focused on this.
10. We should also be doing whatever we can to try and speed up access to this drug (If it works, which they will know, very soon).
11. The main impediment (if it works) to getting this and fixing our lives ASAP is the FDA. Corporations want to make money, not spend money in FDA trials.
12. The ATA can help us in advocacy.
13. I spoke to an ATA associate and they had no knowledge of this drug.
14. They are supposed to be representing us, not us representing them.
15. We need to speak up, in a nice, professional manner.
Call the ATA and very nicely ask them to gain awareness of this drug and reach out to Frequency Therapeutics and the FDA.
Also, the Right to Try Laws wouldn't even exist unless the FDA wasn't too slow. The spirit of this exists enough so that most states and now recently the federal government has passed these laws expressly to cut FDA red tape and get suffering people drugs that may save their lives.
I was shredding my guitar when I hurt my ears. I was really getting up to like shred master level too. Now I'm back on acoustic just playing sing songs and bluegrass.Hope you are right. My tinnitus is noise (heavy metal) induced, yes.
I feel that some people do not want progress in the area. If you go to a sound therapy center and tell them about this drug, they will surely tell you "that will not guarantee that your tinnitus will disappear" or they will underestimate what you say.
There are also many people working on this who does not know many things, even ENTs.
I'll try to contact ATA this weekend. Hope they understand my basic English.