Inner Ear Hair Cell Regeneration — Maybe We Can Know More

@Dave Neale
Please post your question in the most appropriate thread. This one is about Inner Ear Hair Cell Regeneration, not positive stories (yet).
I recall there is a thread on Success Stories. You may find there what you are looking for.
 
I think that's why we have to rely on other countries getting there first, then countries like the US will hopefully start trailing behind in an effort catch up.
 
Anyone have an update on Frequency and Audion's clinical trials? I believe they are recruiting this year but haven't heard much.
 
Meanwhile, AGTC is interested in exploring this area, according to a recent Nasdaq press release. Unlike these start-up companies, AGTC has been around since 1999 and is already an old player in the field of regenerative medicine with a history record of successful treatments.

Frequency hopes to start trials in 2018

Source?
 
I think that's why we have to rely on other countries getting there first, then countries like the US will hopefully start trailing behind in an effort catch up.

No, no, no... you can't rely on other countries. You see, other countries are relying on you! o_O They are relying on the US to get there first! (y) Hehe, you are waiting for us, and we are waiting for you. No one moves! You are the ones you have been waiting for?

I speak for Europe when I say this. We have sent you some of our brightest minds! Use them well! Among them is one of the leading researchers in the field of inner ear regeneration - Stefan Heller. I know the focal point is on Stanford and Harvard. But there are more research labs around the US that work on inner ear regeneration. These research teams gather the best of the best from all around the world, but mainly from Europe and Asia.

This is cutting edge science! I think the US is best suited to pull this off. Mainly because that's where the money is. Individual European countries have a hard time competing with the US. That's why our brightest leave for the US when they feel they have exhausted the academic and monetary resources here and they want to take the next step and get on with the very latest research.

Don't get me wrong, Europe has some of the best scientists in the world and some of the best labs in the world. Stefan Heller is just one example in this narrow field of research. But European countries can only compete with the US if they work together. But even that is being undermined now that UK is leaving the EU.

Within the EU we had the EuroHear project. EU also funded the AFHELO project. Within the Horizon 2020 framework, EU is funding the REGAIN project, as well as the TARGEAR project. I won't go into any details on these since I am running out of time. But these are just some of the projects that EU has funded that targets hearing disabilities. Audion Therapeuthics is one of the lead members of the REGAIN consortium. They received something like 5.8 million EUR from the EU. More funding is pending, and some venture capital firms have also shown interest.

Money, money, money... all about money! Must be funny in a rich man's world! :) But it just goes to show what kind of greater good we can achieve if we come together, share ideas, share resources, manpower and so on. It sure will be felt throughout Europe once UK leaves EU. If they do... they seem to want to go back on that vote, undecided. The UK will also have something to loose too. Bad decision in my opinion!

As I think about, it seems like both the US and the EU has come to a stall. EU is at stall because of economy, geopolitics and immigration floods. US is at stall because of the upside down politics of the new administration. Does the US allow embryonic stem cell research? Why did California need to pass on a new state law that allowed it to continue its groundbreaking work in stem cell research? How does the new administration look at stem cell research? How much are they budgeting for in research funding for the coming year?

I'm afraid US will isolate itself from the rest of the world in the coming years. People from "wrong places" are already being detained at the border, regardless of who they are or what their intention is for the visit. So that promise for a cure to tinnitus by 2020 may need to be pushed further back. Unless of course US can find a cure on its own. Without help of other countries, without collaboration, without foreigners coming in to help advance research, etc.

Whoever gets there first is irrelevant to those of us that suffer from this or these conditions (hearing loss and tinnitus). Likewise, it is mostly irrelevant to the scientists. But I'm afraid all good things get tied up in politics and "national interest".
 
@Samir I know America is at the forefront for research, research and more research. But we are very careful and there are many loopholes to cross before a possible treatment is ready to become available. When I wrote that, I was definitely thinking more along the lines of stem cell therapy and how other countries are able to use different stem cells which are more potent as well as different techniques which are not allowed in the US (for example the stem cell clinic in Korea). So once these clinics gain respect and more business from US patients, we will have no choice but to offer similar treatments (I agree there's a bit of greed involved in the this process unfortunately).

I can also see another country taking our research and running with it in order to develop a cure because there are less regulations and loopholes.
 
But we are very careful and there are many loopholes to cross before a possible treatment is ready to become available.

You mean regulations? All countries have them, but some are more and some are less strict.

When I wrote that, I was definitely thinking more along the lines of stem cell therapy and how other countries are able to use different stem cells which are more potent as well as different techniques which are not allowed in the US (for example the stem cell clinic in Korea).

What kind of stem cells would that be? Embryonic? Sorry, I am not familiar with the Korean clinic you refer to.

Stem cell research, yet alone therapy based on that research has always been a sensitive question for many countries. Since the early years many countries have loosened up on the regulations. Correct me if I'm wrong, but the first cultured line of embryonic stem cells for research came from the US. But my understanding is that George W Bush beaned embryonic stem cell research. But existing lines were allowed to be used for research. Which is why California had to pass on a state law that allowed it to continue its research into stem cells. Which is why California is now the stem cell research hub of the world.

The main obstacle in translating new findings into treatments in the US seems to be FDA. I don't know why that is, but it seems like they are very strict about their regulations. Many promising biotech companies that have emerged and started translating research findings into treatments have been hampered by the FDA. One example is Regenexx.

So I can understand your frustration. Regulations are there to protect us from unsafe treatments. But sometimes I think politics play a bigger role here, and regulation and legislation is outdated. Technological and medical advancements seem to be years ahead of legislation and regulation. So there is definitely a need for a review here, if we want to give leeway for new advancements to translate into treatments faster.

So once these clinics gain respect and more business from US patients, we will have no choice but to offer similar treatments

And this rush to catch up might end up with broken safety barriers and patients get hurt I'm afraid. Which is why it's important that they do this right from the beginning. Instead of having to rush things through.

I can also see another country taking our research and running with it in order to develop a cure because there are less regulations and loopholes.

Which is very much welcome, as I think it's better than having progress stalled because of bureaucracy and outdated regulation and legislation. For the greater good of mankind! Instead of the privileged few.

Let's not talk about our and your research. We all share the same common goal here. The international researchers who work in labs across the US have received higher education and training in their own native countries. That's a major investment for any country. These countries deserve to have some return on their investment. Yes, the US provides facilities and funding, but research doesn't want to do itself. The known saying throw money at it doesn't help here. Research needs smart people who can work together, and collaborate with researchers across borders to achieve a common goal. If the use US is so dull and keeps holding this research back, and then another country picks it up and transforms it into a cure for a disease, then so be it. As long as it cures people of a disease or illness. Be it someone living in the US or elsewhere.
 

Nice find! I know they have been doing inner ear research at Georgetown and I have been following their progress, but I missed this one.

It's nice to see this positive trend and that the amount of research is culminating. I hope that our domestic doctors and researchers are reading this. I sometimes find that I am more informed about current state of research and development than the medical doctors who treat patients on a day to day basis. All they can say is that there is no cure, not to hearing loss nor to tinnitus. That's the easiest thing to say I guess. They have their paycheck at the end of the month, so why should they care. I get this feeling of lack of interest to help people when I meet with "specialists". Maybe they have grown numb over the years, lost the human touch, I don't know. The medical profession is really not for everyone. You need to have profound interest in helping and taking care of people.

Last time I visited one of these specialists 7 days ago for a detailed investigation he used me as a human model for educating one of the new interns. He just kept blabbing about functional physiology, anatomy and the tone audiogram. He didn't offer me OAE nor ABR tests, not even any advice or remit me to a psychotherapist or Internet based CBT. I know these exist, but I had to find out about it myself. I didn't get the information from the (good) old doctors.

So I think it's up to us to inform them about current research and development. They are not in a hurry to treat us. As long as they are not the ones have hearing loss and tinnitus themselves. Of course different countries have different priorities. Some invest more money into research, some invest less. But in Sweden for example, stem cell research has been put on high priority by the government and they set aside extra money into this research. Yet only a handful of researchers are investigating regenerative properties of the inner ear, and only at one research institution I know of. The information on current research is scarce, so it's difficult to get informed on the kind of work they are doing. I find that the US is much more open about it and have the information readily available for the public.
 
Here is what happens when you don't regulate these treatments and you don't offer a legit alternative:

http://www.natureworldnews.com/arti...ics-offer-unapproved-stem-cell-treatments.htm

Warnings about unregulated stem cell clinics have largely turned their gaze on operations in Mexico, China and the Caribbean that promote "stem cell tourism." But the issue apparently lies closer to home for Americans.

Authors Leigh Turner and Paul Knoepfler reported finding the largest number of unregulated stem cell clinics operating in California (113), Florida (104), and Texas (71).
 
I don't know if it was already posted or not but I want to share about that stem cell research ;

http://www.dailymail.co.uk/health/a...implant-restore-hearing-thousands-people.html

It is right below at the page with a little box.

I hadnt seen this, but isnt this the same as what they did to the guinea pigs in 2012 in the UK? Stems cells from a human placenta into the ear of a guinea pig. Wouldnt it be even more effective on a human instead? Why can't they just inject it into a human and see what happens. There are plenty of willing people that I bet would do this. It sounds so simple too.

https://www.ncbi.nlm.nih.gov/pubmed/27863646
This looks like the official writeup of that article.
 
I know this article was posted the "Denver Man Gets Gene Therapy" thread but since it is about Hair Cell Regeneration I believe it should be posted here also.

http://www.hearinglossjournal.com/cgf166-latest-news/

This is actually huge news as there has never been any medical treatment that has restored hearing in a human with SNHL.

It is huge news. Some people did see improvement, but for others it did nothing or actually made it worst. I hope they figure out what the differences were between those that got better and those that got worst. I'm still not sold on this yet, but it is interesting that they will go to phase 3. There was talk of them possibly modifying the formula, but nothing is known for sure or whether they can even change it mid trials. I'm still banking on Decibel or Frequency to come out with something that works better, but those trials are a ways away.
 
Every time in this forums someone put something positive the next post is negative, look like some people enjoy having this f horrendous condition, and every single time kill the hopes. I'm sick and tired of these forums, every 1 good news is 4 bad ones, nothing works for this horrendous condition and every single thing is speculation.
 
One of the issues that we're confronting in terms of trying to find patients who are candidates is the very restrictive criteria that we're using for inclusion. Basically everybody who is a candidate is also a cochlear implant candidate. You have to have that level of hearing loss. But if it's too severe then you're no longer candidate either. So you have to be within a window of severity.

I completely understand their frustration. The feeling is mutual. It's for this reason that I will likely not be a candidate for any trials anytime soon. My hearing is too good.
 
It is huge news. Some people did see improvement, but for others it did nothing or actually made it worst. I hope they figure out what the differences were between those that got better and those that got worst. I'm still not sold on this yet, but it is interesting that they will go to phase 3. There was talk of them possibly modifying the formula, but nothing is known for sure or whether they can even change it mid trials. I'm still banking on Decibel or Frequency to come out with something that works better, but those trials are a ways away.
I read about new improvement in technology of cure ;

https://www.tinnitustalk.com/thread...s-partial-hearing-balance-in-deaf-mice.19820/

I hope they consider this. Can they use this method on next trials?
 
Some people did see improvement, but for others it did nothing or actually made it worst.

Made it worse?... can you post a source?

Every time in this forums someone put something positive the next post is negative

Listen to both sides, then make up your own mind what to believe in.

Can they use this method on next trials?

You mean exo-AAV?


Why not? They have to follow through with the same?

It looks like they are using adenovirus 5 (Ad5).

Source: https://www.novartisclinicaltrials.com/TrialConnectWeb/aboutresult.nov?studyid=54904
 
According to the Hearing Loss Journal blog post describes "detaching the tympanic membrane" and creating "a hole in the cochlea". But the Novartis website states using IL-infusion. Can someone please tell me who is right and who is wrong? Have they suddenly changed the delivery method?

The procedure involves going down the ear canal and detaching the tympanic membrane (ear drum) to reach the cochlea. A laser is used to create a hole in the cochlea to deliver the CGF166.

Source: http://www.hearinglossjournal.com/cgf166-latest-news/

The goal of the study is to evaluate the safety, tolerability, and the potential ability of CGF166 delivered through IL-infusion to improve hearing and vestibular function.

Source: https://www.novartisclinicaltrials.com/TrialConnectWeb/aboutresult.nov?studyid=54904

So they are allowed by FDA to change delivery method in mid trial, but are not allowed to change viral vector? Or what?... I don't get it.

@Aaron123 If they could change delivery method from systemic to intratympanic, why are they not allowed to change the vector from Ad5 to exo-AAV? Makes no sense to me.
 
So they are allowed by FDA to change delivery method in mid trial, but are not allowed to change viral vector? Or what?... I don't get it.

@Aaron123 If they could change delivery method from systemic to intratympanic, why are they not allowed to change the vector from Ad5 to exo-AAV? Makes no sense to me.
They did not change the delivery method.

It's also not at all obvious that this is as simple as just changing the vector to exo-AAV. It may or may not be technically possible. if it is technically possible, I would expect FDA would want a new round of safety evidence since I believe it would be a different biologic agent.

It's also not clear to me that exo-AAV has been used in (or approved for use in) humans. I welcome evidence on this point.

It's also worth keeping in mind that a couple of weeks after the exo-AAV paper was published, a paper using Anc80L65 was published. It will be interesting to see how these two approaches ultimately compare. The second paper showed much better restoration of hearing, but the applications are different.
 
So many doctors and scientists in this forums and unfortunately 100 years we still suffering, for the next 100 years still the same. I'm sorry but I don't see any solution in the near future, we have to be realistic, research is so poor, no help from government and no help from health department, they don't care about tinnitus , hyperacusiss and hearing loss, is so frustrating every year is the same just speculation, I'm preying every day for us suffering, the only thing I can see here is a miracle .
 

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