by Neil Bauman, Ph.D.
Research into regenerating human hair cells in the inner ear, with the aim of restoring hearing, has been ongoing for a number of years. Researchers have been trying, with varying degrees of success, to get hair cells to regenerate in animals—but there are still many hurdles to overcome. Consequently, human trials appear to still be a number of years away.
However, one method has just leapfrogged the competition and has already begun a Phase I clinical trial. (Note: a Phase I clinical trial is done on a very small group of people [in this case 10] to see if the proposed treatment will be safe and identify any resulting side effects. It’s not till Phase II trials that researchers primarily determine just how effective the treatment will be, although preliminary results hopefully will come out of the Phase I trials.)
This Phase I clinical trial is very limited in scope—just for children between the ages of 6 weeks and 18 months who have an acquired (but not genetic) moderate to profound sensorineural hearing loss since birth, and who have had their umbilical cord blood saved by the Cord Blood Registry.
The idea behind this trial is that there are progenitor stem cells floating around in the umbilical cord blood that researchers want to use in this trial. You see, when some babies are born, doctors extract and save the blood left in a baby’s umbilical cord for use later in the same baby if the baby ever needs it. The fancy name for this is “autologous human umbilical cord blood”. Using the baby’s own blood guarantees that the baby’s immune system won’t reject the blood when it is intravenously injected back into the child at some time in the future.
In this trial, researchers will intravenously inject the stored blood back into the same young child that originally “donated” it. What they expect to happen is that the hemopoietic [hee-moe-poy-ET-ik] stem cells [stem cells that make blood cells] still floating around in this umbilical cord blood will make their way to the inner ear where they will become involved in replacing and repairing any damaged hair cells. The hope is that this will ultimately restore some degree of hearing.
As the clinical trial prospectus states: “Pre-clinical data suggest progenitor cell infusions may enhance intrinsic repair mechanisms in the Organ of Corti which may restore hair cells. This treatment could ultimately lead to hearing improvement. Human umbilical cord blood is an available, autologous, stored progenitor cell population available for potential therapeutic use.” (1)
This clinical trial began earlier this year at the Children’s Memorial Hermann Hospital in Houston, TX, and is estimated to be completed by April of 2015.
Results from previous studies using mice showed that cochlear regeneration occurred. “Our findings show dramatic repair of damage with surprisingly few human-derived cells having migrated to the cochlea,” said Roberto P. Revoltella, MD, PhD, lead author of one such study. “A fraction of circulating hemopoietic stem cells fused with resident cells, generating hybrids, yet the administration of hematopoietic stem cells appeared to be correlated with tissue regeneration and repair as the cochlea in non-transplanted mice remained seriously damaged.” (2)
The mice in these studies had had their hearing damaged by either loud noise or by ototoxic drugs. Interestingly enough, cochlear regeneration was less successful in the group deafened by noise than in the group deafened by ototoxic drugs, implying that damage was more severe when induced by noise. Furthermore, regenerative effects were greater in mice injected with a higher number of hematopoietic stem cells. Researchers also found that regeneration of cochlear tissues improved as time passed. (2)
In another year or two, we should know whether this method of restoring hearing (to some degree or other since it obviously wasn’t 100% in the animal studies) will work on young children.
______________
(2) Cochlear Repair after Transplant of Human Cord Blood Cells May Make Hearing Restoration Possible. 2008.
Please consider me for a human clinical trial as soon as it becomes available. I lost my hearing due to bi lateral menieres disease at 16 years old and struggle with everyday life because of it.
Thanks
Sally
salattfield@gmail.com
i would also like to volunteer myself for clinical trials..my hearing has been deteriating since early childhood, more so in my adulthood since working with heavy equipment..
I would love to part of a clinical trial when it becomes available. I started losing my hearing when I was 38 with no known reson.I have had a MRI and Cat Scan and blood work with nothing showing. It is getting worse every year where I now struggle everyday and cant find work that I can get by with.
Hi Neil,
What is the latestavailable information regarding the above CBC stem cell clinical trial, could you give any more detail.
Thanks
http://hearinglosshelp.com/weblog/human-hair-cell-regeneration-clinical-trial-using-stem-cells-begins.php
Hi Erroll:
I haven’t heard anything further from this trial. It wasn’t supposed to be completed until April, 2015 so there are still two years to go.
Regards
Neil
Any news on the experiment? I am looking for news on this type of experimentation this year of 2019. I only just communicated with a deaf person today.
Hi Steven:
I haven’t heard much on hair cell regeneration lately. Research is ongoing, but no one is shouting that they have a breakthrough and a cure is just around the corner. This research is a slow process. I’m not involved in this kind of research so don’t keep up with all the bits and pieces of progress.
Cordially,
Neil
I have had tinnitus since the year 2000.I have heard a lot about stem cell research on the Coast to Coast am radio show with George Norrie and would be very interested in being included in your clinical trials. I am a truck driver by trade and desparatly need my hearing to continue, and be able to provide for my family. I live in Knoxville Tennessee but I would have no problem taking a leave of absence to be including in these clinicals, where ever they are being held. Your consideration would be greatly appreciated.
Sincerely,
Mike Gillean
Hi Mike:
I have nothing to do with clinical trials–I just report on what I find out. So I can’t help you there. Sorry.
To the best of my knowledge, there are no clinical trials going on regarding adult hair cell regeneration. There is lots of activity using animals though. I don’t think they are ready for human trials–and won’t be for a few more years.
Regards
Neil
deaf in one ear for life and losing hearing in other I would like anything any information on this or a place to go to for hearing help cure . I want to be healed
Hi Bets:
I understand your desire to get your hearing back. However, the truth is that hair cell regeneration treatments are still in the testing or experimental stage. You’ll need to wait until the FDA approves such treatments. If you don’t, you may find that hearing loss is the least of your worries if there are untoward side effects.
The best alternative at this point is hearing aids and if they don’t do the job, then consider getting a cochlear implant. At least, this is tried and true technology that works.
Cordially,
Neil
I would like to be part of your trial when it begins. I had progressively worsen hearing. I tried hearing aids with some successes but the did not allow me to hear on the phone. In 2015 I went in and had cochlear implant surgery with the promise that I would hear like a teenager again. Since that time I have been close to completely deaf. I have 2 new grandsons that I have never heard I can not have a conversation with my wife or anyone else. Life is not worth living when you can’t talk to anyone!
thank you
John DeAtley
Hi John:
Not being able to hear is a pain for sure. I’m sorry to hear that your CI didn’t work well for you. Was there a reason for that? Could they reimplant you–would that help?
I assume you have a CI in one ear and nothing or a hearing aid in the other? I can’t see hair cell regeneration working in the implanted ear, but maybe in the other ear. Be aware that this is not my trial study. I was just reporting on it. If you are interested in it, you’d have to contact the study researchers themselves, not me.
Cordially,
Neil
Hi Dr
Do you have a link to check result of trial above was supposed to come out in 2015 ?
Kind regards
Hi Jacob:
No, I haven’t heard a word about it.
Cordially,
Neil
Hello, I am from Algeria, my daughter aged 3 years and 8
months presents a profound deafness, without any abnormality
in the oriel according to the MRI and the scanner, we could
not make him the cochlear implant because the Waiting list
is very large, I want to know if there is a possibility that
she will participate in the clinical tests that you are
going to program in the near future regarding the
regeneration of the ciliated cells, I can send you her file
if you accept the take charge. My most distinguished
greeting.
Je suis de l’Algérie, ma fille âgée de 03 ans et 8 mois
présente une surdité profonde, sans aucune anomalie au
niveau de l’oriel selon l’IRM et le scanner , on a
pas pu lui faire l’implant cochlear car la liste d’attente
est très grande, je veux savoir Monsieur s’il y a une
possibilité qu’elle participe dans les tests cliniques que
vous allez programmer prochainement relatifs au
régénération des cellules ciliés, je peux vous envoyer
son dossier si vous acceptez de la prendre en charge. mes
salutation les plus distinguées.
Hi Ali:
We are not conducting clinical trials. I was simply writing about others and what they are doing. If you want to take part in any trials, you’d have to contact the clinic that is doing the trials directly.
Cordially,
Neil
Hi I have profound hearing loss do to otosclerosis in both ears and had Stapedectomy done on my left ear I haven’t had any change in hearing because the disease went in my inner ear killing the hair cells would i be a canadate for the trail? I have my own stem cells
Hi Tom:
I don’t have anything to do with this trial on hair cell regeneration. I just reported on it. You’ll have to contact the researchers running the trial and ask them if they still want people and if they do, whether you would be a candidate.
Cordially,
Neil
Thank you Neil have you had any cases that after a Stapedectomy there was little improvement due because of inner ear otosclerosis?
Hi Tom:
A stapedectomy will only help if you have otosclerosis in your middle ear (a conductive hearing loss). It does not help for problems in your inner ear (sensorineural hearing loss). Thus, when otosclerosis invades your inner ear, a stapedectomy cannot help that component of hearing loss. But it could still give some improvement in hearing from the conductive component in your middle ear. However, this only works if the hearing loss damage to your inner ear is less than the hearing loss damage to your middle ear.
Cordially,
Neil
As a young child the hairs on my cochlea were burned off due to an injection in my ear. Could this treatment help? Would be grateful if I could be in this clinical trial. Thank you.
Hi Marta:
It’s possible it could help. You can see if you are eligible for the clinical trial, or wait a few years until this treatment goes mainstream–if it ever does. There are no guarantees that the clinical trials will prove to be successful.
Cordially,
Neil
Good Evening, my name is Juli Liporace. I am contacting you for my father, Joseph Liporace. In 2011 he had an operation that ended in him getting hearing loss because of a drug Vancomycin, causing Sensorineural Hearing Loss. He has lost total hearing in one year and only has 10% in the other ear left. I’m reaching out to see if it’s possible we get a second opinion or if you could point me into a good direction. He is very much interested in stem cell clinical to heal the nerve damage. It’s really effected him negatively and we’re just trying to make it better by finding a way to help him. I appreciate you taking the time to read this. Thank you
Hi Juli:
Vancomycin can certainly cause hearing loss. In fact, it is not used much because it is so ototoxic. I agree that this is the most likely cause of his hearing loss.
Hair cell regeneration is not yet available–only clinical trials in some cases. It is still a number of years away. A much better solution at this time is for him to consider getting cochlear implants. I know hundreds and hundreds of people that have cochlear implants and have had amazing results with them. They commonly say, “If I had it to do over again, I’d do it in a heartbeat”. That tells you how well they work for many people.
Cordially,
Neil
Hi, I currently suffer from a hearing condition called otosclerosis. For what ever reason my hearing deteriorated very quickly when my wife died some 6 years. Any hope on the horizon would be most welcome as i struggle like most despite wearing hearing aids. Could this treatment potentially help otosclerosis and what are the procedures id have to go through to get on a trial if the chance arrived?
Hi Elliot:
Otosclerosis is a middle ear condition, whereas hair cells live in the inner ear. Therefore hair cell regeneration will not help with hearing loss caused by otosclerosis.
You don’t say how old you are, but if you are a senior, unfortunately, by the time they get human hair cell regeneration to the point where it’s useful for hard of hearing people, it will probably be too late for you.
Your best bet is still wearing hearing aids, and if hearing aids do not significantly help you, then consider getting cochlear implants.
Cordially,
Neil
I want to know whether this treatment or any other treatment is on horizon for sensorial hearing loss in near future???
Hi Swati:
Researchers are working away on this and other treatments, but so far, they are still years away from going mainstream. So I wouldn’t hold my breathe waiting for these new treatments. I’d use the technology available now such as hearing aids and cochlear implants.
In any case, even if a new treatment came out tomorrow, you don’t want to be the guinea pig. You want to wait a few years to be sure there aren’t any horrible side effects that they haven’t discovered yet.
Cordially,
Neil
If still enrolling participants for this Clinical Lab Research I am interested, very interested.
I was swimming in Lake Mead, just outside Las Vegas, Nevada when my right ear plugged up. I when to the Emergency Room in which they gave me back to back Antibiotics for roughly a month to no avail.
This occurred on July 4th weekend 1998 which caused swimmers ear. My then new girlfriend whom we just celebrated our 29th Wedding Anniversery, took me to her ENT and met Doctor Joseph Tangretti ENT and Allergy Specialist. He diagnosed me correctly and when in a very short time and corrected the swimmers ear in a very short period the swimmers ear was gone but not the damage.
Dr. Tangretti said:
the hearing loss is due to the death of so-called inner ear hair cells. These hair cells (named because they have tiny endings that look like hairs) detect sound waves and then send this information on to the brain.
As they were damaged and that the ringing, hissing, Katydid- Grasshopper sounds just to mention only about 20% of sounds. Plus my hearing is bad in my right ear.
Please Consider my possible candidacy in this Study and/or any future studies in regards to hearing loss! If you are aware of any other Clinical Trials that I could be a Candidate you have My Permission to forward my information to them!!
Thank You In Advance for reading my situation and or your consideration!
In God We/I Trust!!!
Lewis & Becky Kincaid
Hi Lewis:
Your doctor was right. When the hair cells in your inner ears die, you lose some hearing. The more that die, the more hearing your lose at the frequency of the dead hair cells. Typically, hearing loss begins at the high frequencies and works its way down the frequency spectrum.
I have nothing to do with the hair cell regeneration projects. I just report on what is going on. If you want to investigate further, approach the researchers themselves.
Whether this will be a viable treatment in the future is still unknown. They are making progress, but this takes time–especially to identify any unwanted side effects that may take years to show up. You don’t want to be a guinea pig and find out too late that you don’t like the side effects.
In the meantime, you should consider wearing hearing aids or getting cochlear implants so you can hear better now.
Cordially,
Neil
Are there obstacles from the hearing aid and cochlear implant industries?
Hi Karen:
I’ve not heard of any, but who knows what goes on in back rooms?
Cordially,
Neil
I am having ringing in my ears .
I am 54 years and want to know if they have any results on the clinical trials.
Thank you for your reply.
Mark
Hi Mark:
I haven’t heard too much lately on the results of clinical trials on hair cell regeneration. They are still working on it, but I don’t know how soon it will be available (if ever). They still have to get all the bugs out of it before it is ready for public use.
Cordially,
Neil
Those interested in clinical trials for hearing loss may be interested in this one:
https://clinicaltrials.gov/ct2/show/NCT03616223?term=FX-322&rank=1
It is a trial of a cocktail of drugs which they hope might induce ear regeneration. I of course have no idea if it will really work or not, but just thought I would point it out.
That said, the trial described in this article is one that always makes me a bit wary. Since they are taking people’s own biological material (in this case cord blood) it is relatively easy to get approval for this type of trial going. In some cases, people have taken advantage of this to do shoddy work. I am not saying that is what is happening here, but its a good idea to be careful about stem cell clinical trials which give stem cells a bad name. I say all this as someone who works with stem cells.
hopefully, you are done with the trials by now, can you please share results from the stem cell treatment?
Hi There:
I have nothing to do with these trials. I just reported on them.
Cordially,
Neil