Frequency Therapeutics — Hearing Loss Regeneration

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/
 
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?
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.

We both want to be cured and hate the modern paradigm yet I feel like you despise me for some odd reason. Whatever.
 
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/
Part of the FX-322 patent states that they have a method to replicate the rosette pattern of natural hair cells.
 
Where did you find that? I've been looking everywhere.
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.
 
If hair cells are regenerated I fail to see how they would not be as good as the original, the only problem would be a damage area from synapse to auditory nerve they connect to.

Someone correct me if new info comes in about this? I hear contradicting information.
 
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.
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.

Since the early 90's there have been many primitive stimulation devices, not anywhere near advance as University of Michigan's signal timing device but they did follow that logic. Overall that was the only hope tinnitus sufferers had and historically they had also been kept ignorant about tinnitus being caused by hearing loss.
 
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
 
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/
What does this mean for Frequency Therapeutics, is this their results?
Was this a stem cell therapy, gene therapy or progenitor cell therapy?

Are we screwed?
 
@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.

It depends on how well it works... 24 is more than enough if it works. Let's say all of the 16 who get the drug more or less improves and the others with placebo do not then the potency is 100% clear. If it doesn't work it will not matter if there are 24 or 2400 in the trial.

If it works for a certain kind of hearing loss or a certain frequency (say 8 to 10 kHz) which might be present in just a few of the patients then it would be good to have more than 24...
 
Why do you say the first part? And yes, you have to be a US citizen.

Actually not sure why lol. Think I was thinking about the usually up to 8 kHz hearing tests. Darn. Wish I was a US citizen regarding this trial then. If only they organized one in EU as well :(
 
How much of FX-322 would anyone need if the cochlea is the size of a pea/fingernail? It doesn't seem like they'd need too much. (I know we've kinda been over this before but it really doesn't seem like that much at all)
 
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.
 
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.

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.
 
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.
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.
 

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