Inner Ear Hair Cell Regeneration — Maybe We Can Know More

[XDR]

Both clinics appear to use your own cells (Fat) via liposuction.

Unproven snake oil.

Wait until Novartis competes its study into the technique next year.
https://www.actiononhearingloss.org...irst-gene-therapy-trial-for-hearing-loss.aspx

https://www.novartis.com/stories/discovery/can-we-unlock-bodys-ability-regenerate-lost-hearing

 

[Pleasure_Paulie]

Another string in the bow as we move closer to treatment

 

[Aaron123]

Short article in The Atlantic on restoring hearing http://www.theatlantic.com/health/archive/2016/07/human-hearing-loss-could-be-reversible/491777/ It mentions Albert Edge and Audion as well as Frequency Therapeutics which is a new name to me. It was founded by Robert Langer at MIT and Jeff Karp at Harvard. Neither person seems to publish specifically on hearing. Karp does a lot of work with stem cells, and Langer seems to do work with nanoparticles and drug delivery. Enticingly, the article says that Frequency Tx had no comment because "they are in "stealth mode" pending a big research announcement." Will be interesting to see what they are up to. There is nothing on their web site http://www.frequencytx.com/ Anybody know more about them?

 

[RB2014]

Great find Aaron. I research and read daily and this is the first that I have heard of them. I'm guessing and hoping that these companies are now far beyond what we read on the internet in terms of research and development. Once companies get a hold of this stuff its hush hush. The first to the market will reap huge rewards until other options are available too. Of course, anything that requires a clinical trial is going to take a while.

 

[Aaron123]

Interesting new paper that looks at the influence of Notch and Wnt signaling separately and together on supporting cells and hair cells. Perhaps unsurprisingly finds that you can do better by manipulating both compared to manipulating only one. http://www.nature.com/articles/srep29418

 

[Aaron123]

Found a bit more information about Frequency Tx. Looks like they are working with stem cells possibly with small molecules as a drug delivery method. Emphasis added

1) David L. Lucchino is Co-Founder, Chairman and CEO. From his Linkedin page "Frequency Therapeutics, is an innovative biotechnology company on the forefront of translating ground breaking discoveries in the area of cell programming, an approach recognized with the 2012 Nobel Prize, to patients. Frequency has solved a key bottleneck in bringing stem cell programming to patients - namely by harnessing rapidly translatable small molecule combinations that selectively target stem cells in the body. The company is advancing a robust pipeline of small molecule combinations with novel mechanisms of action, for hearing loss, gut diseases (including IBD), and ophthalmological diseases. "

2) Will J. McLean, PhD Co-founder & Vice President, Biology & Regenerative Medicine
https://www.linkedin.com/in/will-j-mclean-phd-a66b7b11 Linkedin summary "Stem Cell Biologist and Neuroscientist developing novel drug therapies to restore hearing through regenerative medicine. Private Sector Consultant in biology for Entrega Bio, Third Rock Ventures and Merck/Millipore. Post Doctoral Fellow at Harvard Medical School, Massachusetts Eye and Ear Infirmary; research on developing an artificial cochlea to mimic native organ. Doctoral research on the functionality of inner ear sensory cells generated from stem cells using electrophysiological techniques and molecular gene expression methods. Research published in multiple peer reviewed and invited publications."

3) Raj Manchanda, PhD, Senior Vice President, Drug Development and Technical Operations, https://www.linkedin.com/in/rajmanchandaphd

 

[Nick Pyzik]

Found a bit more information about Frequency Tx. Looks like they are working with stem cells possibly with small molecules as a drug delivery method. Emphasis added

1) David L. Lucchino is Co-Founder, Chairman and CEO. From his Linkedin page "Frequency Therapeutics, is an innovative biotechnology company on the forefront of translating ground breaking discoveries in the area of cell programming, an approach recognized with the 2012 Nobel Prize, to patients. Frequency has solved a key bottleneck in bringing stem cell programming to patients - namely by harnessing rapidly translatable small molecule combinations that selectively target stem cells in the body. The company is advancing a robust pipeline of small molecule combinations with novel mechanisms of action, for hearing loss, gut diseases (including IBD), and ophthalmological diseases. "

2) Will J. McLean, PhD Co-founder & Vice President, Biology & Regenerative Medicine
https://www.linkedin.com/in/will-j-mclean-phd-a66b7b11 Linkedin summary "Stem Cell Biologist and Neuroscientist developing novel drug therapies to restore hearing through regenerative medicine. Private Sector Consultant in biology for Entrega Bio, Third Rock Ventures and Merck/Millipore. Post Doctoral Fellow at Harvard Medical School, Massachusetts Eye and Ear Infirmary; research on developing an artificial cochlea to mimic native organ. Doctoral research on the functionality of inner ear sensory cells generated from stem cells using electrophysiological techniques and molecular gene expression methods. Research published in multiple peer reviewed and invited publications."

3) Raj Manchanda, PhD, Senior Vice President, Drug Development and Technical Operations, https://www.linkedin.com/in/rajmanchandaphd

Great find Aaron123. Do you think Frequency Therapeutics is working with stem cells specifically for hair cell regeneration or for nerve fiber/spiral ganglion neuron regeneration?

 

[Foncky]

I wrote to the European REGAIN project. I hope I'll be able to participate in the clinical study when/if they start it in the next few years.

Will keep you updated.

A lot of great finds these days, keep posting guys.

 

[Aaron123]

Great find Aaron123. Do you think Frequency Therapeutics is working with stem cells specifically for hair cell regeneration or for nerve fiber/spiral ganglion neuron regeneration?

Information is pretty sparse. However, McLean's doctoral research was on " the functionality of inner ear sensory cells generated from stem cells". Also, the Boston Globe article discussing the launch of Decibel mentions Frequency: "Another hearing-related company, Frequency Therapeutics Inc., of Cambridge, was started last year by Robert Langer, institute professor at the Massachusetts Institute of Technology, who has helped launch dozens of biotech and medical technology startups. Frequency will be trying to regenerate hair cells to improve hearing in the inner ear." https://www.bostonglobe.com/busines...-treatments/fXhqxTHV5JhCoyFsk425uI/story.html

Given that, I would assume they are focused on hair cells.

 

[Reinier]

@Foncky
I did a search on the internet: http://regainyourhearing.org/
Do you know if something has been posted about this project earlier on this forum?

 

[Nick Pyzik]

Information is pretty sparse. However, McLean's doctoral research was on " the functionality of inner ear sensory cells generated from stem cells". Also, the Boston Globe article discussing the launch of Decibel mentions Frequency: "Another hearing-related company, Frequency Therapeutics Inc., of Cambridge, was started last year by Robert Langer, institute professor at the Massachusetts Institute of Technology, who has helped launch dozens of biotech and medical technology startups. Frequency will be trying to regenerate hair cells to improve hearing in the inner ear." https://www.bostonglobe.com/busines...-treatments/fXhqxTHV5JhCoyFsk425uI/story.html

Given that, I would assume they are focused on hair cells.

Thanks for the information Aaron. Appreciate it.

 

[Foncky]

That's it !

I don't think I read something about it before on TT. But it was discussed in a link posted a few days ago by a member : http://www.theatlantic.com/health/archive/2016/07/human-hearing-loss-could-be-reversible/491777/

 

[Foncky]

If anyone needs anything Dutch translated (since Audion Therapeutics is a Dutch company) hook me up.

What I found about them:

Audion Therapeutics is building on research from the Edge laboratory of the Massachusetts Eye and Ear Infirmary (MEEI). Audion's lead program focuses on small-molecule drugs that trigger the regeneration of hair cells in the inner ear. Audion has exclusive rights to MEEI-developed technology and the IP portfolio comprises molecules and drug-discovery tools for hearing and hearing-loss research.

It is a very small company though. And 8,3 mln euro's of funding might not be enough to succesfully develop such a major discovery.

If you look here it's part of the Horizon2020 programme which funds these types of researches.

The due date for the project is november 2018.

http://www.narcis.nl/research/RecordID/OND1358497/Language/nl

 

[jdjd09]

That's it !

I don't think I read something about it before on TT. But it was discussed in a link posted a few days ago by a member : http://www.theatlantic.com/health/archive/2016/07/human-hearing-loss-could-be-reversible/491777/

So, are they saying that a cure should be out within the decade they think?

 

[Mario martz]

So, are they saying that a cure should be out within the decade they think?

Yes Within the decade,
Plus they say its already like a war between laboratories they are fighting to be the first to find the "cure" for hearing loss, we have this guys, decibel, otonomy, auris and the other one i can not remember...

 

[Nick Pyzik]

So, are they saying that a cure should be out within the decade they think?

We don't even know if hair cell restoration will help a person with hearing loss. There was a candidate of the GenVec - CGF166 clinical trial named Jeff Bricker. Back in late Decemeber, while I was on the hunt to find a hair cell hearing loss, I stumbled across Jeff. I believe I found his name on a blog-ish site where a relative of his was keeping an update on how his trial was going. I decided to find the man on Facebook and friend him so I could learn much more about this amazing new feat.

I was in the hair cell loss = hearing loss phase at the time too.

Jeff effortlessly accepted my request on Facebook and that day I spoke to him through the Facebook chat.

Key points to what he told me the few times I spoke to him over a period of months back in the winter:

1) He was one of the first out of all the GenVec patients to receive a 40 micro liter dose injection of CGF166.

2) He had many instances of picking up new noises. Jeff stated to me, "It sounds sometimes like a water cooler when the bubbles come up. Other times it sounds like chords being played on an organ. Very weird and nerve racking sometimes."

He also stated that he would pick up robotic like sounds and that he's always had trouble hearing in noisy areas.

3) Jeff's right ear was used for the injection. I asked Jeff one day what music sounded like with his noticeable hearing changes. He stated this, "I tried listening through the Bluetooth through my hearing aids and then taking the aids out and using ear buds. The results were the same. The sound was only coming into my left ear and poor quality at that. The right ear that I had the injection on didn't pick up the sounds. Don't know what to make of it as my right ear has been all over the board this week picking up weird sounds internally if that makes any sense. I guess that I will have to wait and see what develops."

4) In the end, it seemed like the opportunity to create better hearing for Jeff through this trial, only caused more difficulties.

This post on Jeff's Facebook on June 22, 2016, sealed the deal.

"Tuesday will mark the final step in a long journey to regain some hearing again. The Gene Therapy Trial didn't work on me and in the case of a few other Lab Rats, like myself, actually created more hearing loss. I will get a Cochlear Implant on Tuesday that hopefully will restore a portion of my hearing. Can't wait to become Bionic !"

Since Jeff posted this bold statement on his Facebook, it's best to believe that those associated with Novartis/GenVec, allowed him to do so. Therefore, I should have no problem posting information about the results of such a groundbreaking hearing loss trial. I even contacted Jeff about 2 hours ago to ask him if it was okay to post this. He responded, "Sure nothing confidential there, hope it helps."

If needed be, I can provide visual documents of my conversations with Jeff.

 

[bill 112]

We don't even know if hair cell restoration will help a person with hearing loss. There was a candidate of the GenVec - CGF166 clinical trial named Jeff Bricker. Back in late Decemeber, while I was on the hunt to find a hair cell hearing loss, I stumbled across Jeff. I believe I found his name on a blog-ish site where a relative of his was keeping an update on how his trial was going. I decided to find the man on Facebook and friend him so I could learn much more about this amazing new feat.

I was in the hair cell loss = hearing loss phase at the time too.

Jeff effortlessly accepted my request on Facebook and that day I spoke to him through the Facebook chat.

Key points to what he told me the few times I spoke to him over a period of months back in the winter:

1) He was one of the first out of all the GenVec patients to receive a 40 micro liter dose injection of CGF166.

2) He had many instances of picking up new noises. Jeff stated to me, "It sounds sometimes like a water cooler when the bubbles come up. Other times it sounds like chords being played on an organ. Very weird and nerve racking sometimes."

He also stated that he would pick up robotic like sounds and that he's always had trouble hearing in noisy areas.

3) Jeff's right ear was used for the injection. I asked Jeff one day what music sounded like with his noticeable hearing changes. He stated this, "I tried listening through the Bluetooth through my hearing aids and then taking the aids out and using ear buds. The results were the same. The sound was only coming into my left ear and poor quality at that. The right ear that I had the injection on didn't pick up the sounds. Don't know what to make of it as my right ear has been all over the board this week picking up weird sounds internally if that makes any sense. I guess that I will have to wait and see what develops."

4) In the end, it seemed like the opportunity to create better hearing for Jeff through this trial, only caused more difficulties.

This post on Jeff's Facebook on June 22, 2016, sealed the deal.

"Tuesday will mark the final step in a long journey to regain some hearing again. The Gene Therapy Trial didn't work on me and in the case of a few other Lab Rats, like myself, actually created more hearing loss. I will get a Cochlear Implant on Tuesday that hopefully will restore a portion of my hearing. Can't wait to become Bionic !"

Since Jeff posted this bold statement on his Facebook, it's best to believe that those associated with Novartis/GenVec, allowed him to do so. Therefore, I should have no problem posting information about the results of such a groundbreaking hearing loss trial. I even contacted Jeff about 2 hours ago to ask him if it was okay to post this. He responded, "Sure nothing confidential there, hope it helps."

If needed be, I can provide visual documents of my conversations with Jeff.

With results like this then what has them so hopeful?This isn't good news in my eyes at least,but maybe they tweaked it since then and now it's more effective?Who knows only time will tell.

 

[Ears Hurt]

@bill 112 @Nick Pyzik Seriously, it doesn't seem promising hearing that story. I feel like everything out there leads to another dead end. Everything seems so doom and gloom. How ironic that we have the one symptom that has no cure, doesn't kill us, but makes us give up on life.

 

[RB2014]

Nick, thanks for posting. I am agreed that this is not the best news, but I think this trial more about seeing if the gene can be safely tolerated at this point than trying to regrow hair cells. We already know it didnt work in Rob Gerk who was the first person to try this therapy. I look for updates on his twitter account every now and then and there is nothing there.
I also wonder if the trial was postponed because of the robotic sounds that me mentioned or the more hearing loss that he encountered. I guess if you are already that low it really doesn't matter much and a cochlear implant is the way to go.
I was hoping to enroll in a clinical trial, but after seeing this I think I would now reconsider that. I guess we really don't know how these therapies will affect the inner ear in a human vs a lab animal. I know dosage was another key element in the clinical trials as too much gave worst results. I don't think that was the case at 40ml though, but it could also have been not enough. Really, they don't know what the proper dosage is at this point.
They know more now than when they came out with this formula. I wonder if this is going to be a recurring theme, where they get the trial going, improve the formula, but then have to start a new trial all over again. I think thats the way it works. It would be great if they could just does everyone in the first two weeks and then see what happens. If we end up waiting a few weeks per participant, then each trial is going to be very long.

 

[bill 112]

@bill 112 @Nick Pyzik Seriously, it doesn't seem promising hearing that story. I feel like everything out there leads to another dead end. Everything seems so doom and gloom. How ironic that we have the one symptom that has no cure, doesn't kill us, but makes us give up on life.

That's how I feel Earshurt,everything builds us up with hope and dreams with all the incredible results in a lab only to bomb when it comes to the real problem,us.

I hate it so much and I couldn't agree more with your above post,but however I do have a very inspiring story to share with everyone here that 100% rebuilt my hopes,I'm going to jump on the laptop and post it in support,I'll tag you in it.

 

[Nick Pyzik]

With results like this then what has them so hopeful?This isn't good news in my eyes at least,but maybe they tweaked it since then and now it's more effective?Who knows only time will tell.

I'm telling you. They aren't looking at hearing loss correctly. It's the nerve fibers of the spiral ganglion neurons that cause hearing problems, ringing, and much much more.

I'm not denoting sensory hair cells though. I'm sure those who may have lost hair cells through ototoxicity may benefit from such a procedure. From the bottom of my heart though, hearing is all in how our brains process sound. They are putting too much emphasis on the front runners of our hearing. I don't understand why.

Time will only show.

 

[dan26]

these things take so much time and i hope i'm not dead and gone when they do find a cure. Suffering a long time and
if i hit the lottery jackpot, which is unlikely, I'd donate lots of money to advance any type of research to restore hearing and/or cure tinnitus! Massachusetts Eye & Ear does a lot of work pertaining to that.

 

[Ears Hurt]

@bill 112 Looking forward to reading your post this morning. I just saw the message of hope you posted. I think lots of people can use a major pick me up. I am starting to think they same way as you @dan26. I think by the time they find a cure it will be too late for me. These things seem to take way too long. I mean they found out birds regenerate hearing in the 80s. Its 2016 now! How much progress have we really make?

 

[vegasjon]

That's how I feel Earshurt,everything builds us up with hope and dreams with all the incredible results in a lab only to bomb when it comes to the real problem,us.

I hate it so much and I couldn't agree more with your above post,but however I do have a very inspiring story to share with everyone here that 100% rebuilt my hopes,I'm going to jump on the laptop and post it in support,I'll tag you in it.

This is why I simply can't ever get my hopes up.

 

[Reinier]

In 2017 we will know what percentage of people participating in the GenVec trial improved. I think it is way too early to draw conclusions.
If we look at statistics I think we will see a serious increase in companies and universities with interesting research and findings. GenVec happens to be the first.

 

[Drecul]

Apparently a dutch company called Audion Therapeutics is doing human trials right now after a successful result in mice. They expect the first results in 2017 and the trails will be finished in 2018. They inject stem cells in the ear drum to repair hearing loss.

Here is an article (in dutch) http://3voor12.vpro.nl/nieuws/2016/Juli/Gehoorschade.html

 

[bill 112]

This is why I simply can't ever get my hopes up.

I try not to also but sometimes when you see what they are doing its hard not to get a little excited regardless of what the outcome is,we just have to keep on waiting and maybe just maybe they will finally hit a home run.

 

[Aaron123]

Apparently a dutch company called Audion Therapeutics is doing human trials right now after a successful result in mice.

That's interesting. According to the director of research in an article posted on June 26, trials are expected to start next year.

SYNAPSE: What is the timeline for clinical trials of Audion's therapeutic?

GILL: We've been developing our program with Eli Lilly for a couple of years and we hope to begin clinical trials next year. Our clinical development program is largely supported by a grant backed by the European Union, which involves clinical investigators and research institutions in five countries and this includes Eli Lilly.

http://synapse.mit.edu/2016/06/26/john-gill/

 

[Onnie]

@Drecul

I might be wrong but I don't think they inject stem cells. They inject something that will make the stem cells in your ear repair the hair cells that died.. At least that is what I believe the article states.

 

[Drecul]

That's interesting. According to the director of research in an article posted on June 26, trials are expected to start next year.

http://synapse.mit.edu/2016/06/26/john-gill/

They say to expect the first results in the beginning of 2017 and trails to be finished in 2018. So they must be testing now or very shortly.