Inner Ear Hair Cell Regeneration — Maybe We Can Know More

[tomytl]

I understand the feeling of despair. Everything which is forever is scary, and some tinnitus seems to be forever today. However you will get use to it and habituation is real. If it comes a cure it will come a cure. The thing is that if it takes 30 years from now does it mean you are 30 years older, and you will regret that you wasted so many years. And i don't think they will solve aging-process before the solve tinnitus so..

I hope there will be a cure!! But i have to stay by the opinion that if you put all your hope to different companies will you sink deeper and deeper down into despair if their trials fails.

This is a great forum and you really find the latest research here! So i come back from time to time.

Please take care everybody! And try to see the sounds as less bad, your thoughts about the sound makes all the difference.

Indeed, nobody knows if and when and where and how good a possible treatment might work.
But this thread is about hair cell research and tracks current developments and we share infos. I got ear problems 15 years ago and I was always doing research on the net about hair cell regeneration and it's just exciting that some projects moved from discovery into clinical trials now.
For me, it wasn't wasted time and I didn't sinked deeper because of all this research, it's the opposite, it often made my day!!
But I also understand what you mean and some people might handle this as you mentioned. Everybody is different and also has different degree and types of hearing problems.
This forum ist just awesome with many great people!

 

[Contrast]

But this thread is about hair cell research and tracks current developments and we share infos. I got ear problems 15 years ago and I was always doing research on the net about hair cell regeneration and it's just exciting that some projects moved from discovery into clinical trials now.

Can you describe what went on 15 years ago compared to now. Would you say now is more exciting then ever or is it just a merry go round of false promises and failure? Were there any clinical trials for hair cell regeneration before?

 

[jeff W]

Can you describe what went on 15 years ago compared to now. Would you say now is more exciting then ever or is it just a merry go round of false promises and failure? Were there any clinical trials for hair cell regeneration before?

I presume you mean humans, then no there was nothing but mouse models and the odd primate study. Welcome to the future.

 

[tomytl]

In the February newsletter of the Hearing Health Foundation www.hhf.org
the first article is about their consortium to cure hearing loss. It's very encluraging what they write.
Source: hhf.org
Hearing Restoration Project (HRP) Conducts Fruitful February Meeting
On February 10, the HRP convened during the annual meeting of the Association for Research in Otolaryngology (ARO) in San Diego. Five members delivered presentations on their projects with great dialogue and interactive commentary. "All projects are on track and are yielding interesting results," according to Scientific Director Peter Barr-Gillespie, Ph.D. Board Chair Elizabeth Keithley, Ph.D., also present, said, "It was wonderful to see how far they have progressed since the inception of the group in 2011. I am confident that our efforts to regenerate hair cells will be successful." To conclude, the group heard a spirited call to action from Scientific Advisory Board member Dr. David Pauls, who drew on his experience with other scientific consortia to exhort the HRP to take advantage of all the benefits such consortia bring

 

[crd3]

It can be that there is no lineair relation between damage to the hearing cells and the level of tinnitus. So in some case the hearing test shows a perfect result still there is tinnitus which is caused be the little damage not detected by the test. This is just my idea. No proof.

My hearing is perfectly normal according to an OAE. The only real indications of damage are T and decrease in LDLs. So either I damaged hair cells that weren't tested, or I damaged something else, such as synapses. I think the latter is more likely since I'm pretty sure I have an abnormal amount of trouble picking out conversations in noise, which is a primary indication.

I sure hope that our tools for diagnosing inner ear problems improve soon; even with these treatments I'm still gonna be flying blind until we have that.

 

[jcloth]

My hearing is perfectly normal according to an OAE. The only real indications of damage are T and decrease in LDLs. So either I damaged hair cells that weren't tested, or I damaged something else, such as synapses. I think the latter is more likely since I'm pretty sure I have an abnormal amount of trouble picking out conversations in noise, which is a primary indication.

I sure hope that our tools for diagnosing inner ear problems improve soon; even with these treatments I'm still gonna be flying blind until we have that.

I don't think OAEs measure above 8k, just like standard hearing tests. Mine didn't anyway. Listen to a frequency sweep on low volume on decent full range headphones or speakers and see what happens at the higher frequencies. Probably some hearing loss there

 

[Ozwel]

Who knows. Maybe 20 years or hopefully sooner. Actually it is more and more admitted that hearing loss can lead to dementia, and by this occasion launch alzheimer much earlier on persons with risk, so if this issue is more and more recognized, it may be shorter until a full cure

Hi, what is your source? Hearing loss leading to Alzheimer is quite a claim.

You also claim hearing loss may trigger dementia but what about tinnitus?

I'm actually asking because I find myself to be more and more mentally tired. And by tired I mean it's harder to focus on things such as intellectual work, speech, etc. Like my mind is away from my body. I'm looking for my words more and more often, etc.

I'm only 33 year-old and working hard for my career. I need all my head (intellectual job in IT, leading open talks, etc.). So I have to say I'm a bit concerned by my mental health. For the moment I'm just convincing myself it's just anxiety - which tinnitus enables from time to time (I'm living with it permanently for 13 years now).

 

[tomytl]

Hi, what is your source? Hearing loss leading to Alzheimer is quite a claim.

You also claim hearing loss may trigger dementia but what about tinnitus?

I'm actually asking because I find myself to be more and more mentally tired. And by tired I mean it's harder to focus on things such as intellectual work, speech, etc. Like my mind is away from my body. I'm looking for my words more and more often, etc.

I'm only 33 year-old and working hard for my career. I need all my head (intellectual job in IT, leading open talks, etc.). So I have to say I'm a bit concerned by my mental health. For the moment I'm just convincing myself it's just anxiety - which tinnitus enables from time to time (I'm living with it permanently for 13 years now).

Hi,
I think not all kind of hearing loss conditions will lead to dementia or alzheimer or whatever...
So no panic for that.
How long a cure for hearing loss will take, nobody knows...10 years is the same speculation like 20 or 30.
But we probably get a first answer if latest research is on track or not in the next few years.

 

[crd3]

I don't think OAEs measure above 8k, just like standard hearing tests. Mine didn't anyway. Listen to a frequency sweep on low volume on decent full range headphones or speakers and see what happens at the higher frequencies. Probably some hearing loss there

I've done that too, can hear all the way up to 16kHz, which is within normal range for my age (25). Also, my more bothersome tone is 500Hz, which is pretty low.

My OAE definitely went to at least 12k but I don't have the graph in front of me.

 

[jeff W]

Hi,
I think not all kind of hearing loss conditions will lead to dementia or alzheimer or whatever...
So no panic for that.
How long a cure for hearing loss will take, nobody knows...10 years is the same speculation like 20 or 30.
But we probably get a first answer if latest research is on track or not in the next few years.

Can you imagine a trial is run on a geriatric ward and neurological disorders began to reverse after hearing recovery? You could factor in about a trillion dollars of neuro med patents into a valuation for such a treatment, and yes I believe hearing recovery in the old will have profound neurological effects like nothing ever seen before.

 

[Canadaman]

Can you imagine a trial is run on a geriatric ward and neurological disorders began to reverse after hearing recovery? You could factor in about a trillion dollars of neuro med patents into a valuation for such a treatment, and yes I believe hearing recovery in the old will have profound neurological effects like nothing ever seen before.

It reminds me of vision in children.

Sometimes a whole school system can end up thinking a child is mentally slow, and then it turns out that he just had bad eyesight. He couldn't read the blackboard, but he had no reference point to realize something wasn't right about his eyes.

This is why schools do a lot of vision testing these days, I've heard.

 

[Yusher]

When Frequency is planning to start 2 trial who knows?

 

[Autumnly]

When Frequency is planning to start 2 trial who knows?

Phase 2 is expected to start in the second half of the year

 

[vaka]

Phase 2 is expected to start in the second half of the year

Yeah Nicccce! They are super fast.

 

[jer]

Luckily for us, science/medicine works in an exponential way. That means that instead of seeing linear improvements, every new small improvement will stack upon existing knowledge. So every year will bring massive improvements that will stack upon each other.

I believe there was talk a number of years ago that we would not see hair cell regeneration in our lifetimes, and look at where we are now. People also have to understand that our successes (and even every failure) teaches the scientists something new which moves us dramatically forward and pushes us more into the exponential curve. Math is a wonderful thing people, it makes the whole world make sense.

 

[PolishSoldier87]

What next if they success? Next trials?

 

[Autumnly]

What next if they success? Next trials?

Yes. Frequency Therapeutics plans to begin phase 2 this year and if successful phase 3 should follow. "The company then (after phase 3) submits an application to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe."
From what I've read phase 2 can take up to two years and phase 3 up to four years.
https://www.drugs.com/fda-approval-process.html
https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm

 

[TheDanishGirl]

Yes. Frequency Therapeutics plans to begin phase 2 this year and if successful phase 3 should follow. "The company then (after phase 3) submits an application to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe."
From what I've read phase 2 can take up to two years and phase 3 up to four years.
https://www.drugs.com/fda-approval-process.html
https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm

So if it works we are looking at up to 8½ year before it is available to us? DAMN that is a long time! :/

 

[PolishSoldier87]

Why losing hope Sandra?

 

[Autumnly]

So if it works we are looking at up to 8½ year before it is available to us? DAMN that is a long time! :/

Yeah, unfortunately. And as others have said that would probably be the most optimistic case and no one can predict what will happen during phase 2. (And then you'd also have to consider when this medication would be available in Europe and how much it would cost). Approximately 33% of drugs move from phase 2 to phase 3. However, I try to look at it from this side: what is having to wait for a decade for a new treatment compared to getting the rest of your life back? I keep telling myself to hold on for another ten years. I'm hoping Susan Shore's device will be available in the next couple of years... and I'm hoping that Affichem's new drug will be available in under a decade.

 

[TheDanishGirl]

Yeah, unfortunately. And as others have said that would be the most optimistic case and no one can predict what will happen during phase 2. (And then you'd also have to consider when this medication would be available in Europe and how much it would cost). Approximately 33% of drugs move from phase 2 to phase 3. However, I try to look at it from this side: what is having to wait for a decade for a new treatment compared to getting the rest of your life back? I keep telling myself to hold on for another ten years. I'm hoping Susan Shore's device will be available in the next couple of years... and I'm hoping that Affichem's new drug will be available in under a decade.

It is not so much waiting 8½ years, but the fact that it takes 5+ years for a drug/treatment to hit the market after it has been proven it works. It is ridiculous that it has to take that long, in my opinion.

 

[grate_biff]

Just some reasons I can think of that should/could make the process for fx-322 to move faster than regular drug testing:

-unmet marked ( there is something called "fast tracking", do not know how common that is.
-this is not made to go into our bloodstream or affect our brain in any way(though I guess it will enter our bloodstream somewhat, bc it will eventually be swollowed, but Sfx should be lesser of a concern)
-as a startingpoint, it´s a one time administration type deal (side effects should thus be minimal)
-if it works, it will be easy to measure. Placebo can´t interfere in hearing a tone or not. It can maybe interfere with T and H feel of intrusion, but not if it´s there or GONE!

These "facts" should make things go faster both during and post trial should it not?

Am, I wrong?

 

[grate_biff]

There are T suffers here without hearing loss

Ask them to show you their 8-16 kHz audiogram.

 

[Yusher]

What about Audion?When they will start 2 phase?

 

[Autumnly]

What about Audion?When they will start 2 phase?

• Like the Genvec trial, it is a Phase 1/2 trial which is why they talked about starting Phase 1 and Phase 2 in 2017 (though in one place they say it starts in 2016 and ends in 2017). The "intention to publish" date is January 2020. As is standard, part (phase) 1 is the safety trial and part (phase) 2 is efficacy. There is no placebo.

• The REGAIN trial is currently open to participants in the UK that are able to travel to the Royal National Throat Nose and Ear Hospital in London.
• A Phase I/II multiple ascending dose open-label safety and efficacy study of the Notch Inhibitor LY3056480 in patients with mild to moderate SNHL

 

[Andrei90]

Just some reasons I can think of that should/could make the process for fx-322 to move faster than regular drug testing:

-unmet marked ( there is something called "fast tracking", do not know how common that is.
-this is not made to go into our bloodstream or affect our brain in any way(though I guess it will enter our bloodstream somewhat, bc it will eventually be swollowed, but Sfx should be lesser of a concern)
-as a startingpoint, it´s a one time administration type deal (side effects should thus be minimal)
-if it works, it will be easy to measure. Placebo can´t interfere in hearing a tone or not. It can maybe interfere with T and H feel of intrusion, but not if it´s there or GONE!

These "facts" should make things go faster both during and post trial should it not?

Am, I wrong?

That's basically what I'm saying. The first trial has been going on for months already. I think they already gathered data on the delivery method. The safety component should be the focus now. Understandably, they will take time here and study any long term effects. My interest would be trial 2. I don't know how long the cells will take to grow but nerves can grow up to an inch in just a month. The cells in question are smaller so it should be even a shorter time. As soon as they have this information (if it works) just fast track the whole thing. They know it will be safe at that point. Get this out as soon as possible!!!

 

[Canadaman]

There is a chance you could get in the phase 2 or phase 3 trials.

Phase 3 trials especially, as I understand, tend to be quite large.

It'd be great if someone from the forum could get involved.

 

[jeff W]

There is a chance you could get in the phase 2 or phase 3 trials.

Phase 3 trials especially, as I understand, tend to be quite large.

It'd be great if someone from the forum could get involved.

Phase 3s????????

I was recently told by a non-believer that cellular repair is useless as most ear disorders are systemic in that the underlying cause is immune mediated (a malfunction of some sort and not a pathogen). I beg to differ, but there are those who believe that tinkering with immune response is a more realistic therapy in the coming years.
We will see.
http://docdro.id/zPlTi18

 

[RB2014]

https://www.businesswire.com/news/h...ologies-Signs-Exclusive-License-IU-Innovation

I've been following the work at Indiana university and noticed this today. Hopefully this speeds up the process.

 

[crd3]

Ask them to show you their 8-16 kHz audiogram.

Sure, what address should I send it to?