FDA Approves Phase I Stem Cells for Babies with Hearing Loss

UPDATE: Check out one of the deaf children's progress here.

There's a new FDA approved cord blood stem cell safety study to be done on deaf children age 6 weeks to 18 months who acquired sensorineural hearing loss (nonsyndromic deafness). This is a year long study.

Children’s Memorial Hermann Hospital and Cord Blood Registry® (CBR) are launching the first FDA-approved, Phase I safety study on the use of cord blood stem cells to treat children with sensorineural hearing loss.

The study, which will use patients’ stem cells from their own stored umbilical cord blood, is the first-of-its-kind, and has the potential to restore hearing. This follows evidence from published laboratory studies that cord blood helps repair damaged organs in the inner ear.

The year-long study will follow 10 children, ages 6 weeks to 18 months, who have sustained post-birth hearing loss. Children who are deaf as a result of a genetic anomaly or syndrome are not eligible. To ensure consistency in cord blood stem cell processing, storage, and release for infusion, CBR is the only stem cell bank providing clients for the study.

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Researchers will obtain and process the patients’ stored cord blood for treatment. The cells then will be given to the patients via IV infusion, and patients will be observed for several hours in the hospital.

Patients will return to the hospital to repeat all tests except the MRI at one month and one year, and all tests with an MRI at six months.

“This study is exciting because it might offer a non-surgical option for some children with profound loss,” Linda Baumgartner said. “More importantly, this is the first treatment with the potential to restore normal hearing.”

The new Phase 1 study already began in April 2011 and will end April 2015 although the collection on final study results will end in April 2014. This study will use stem cells from cord blood saved at a cord bank after a baby is born. Stem cells from the deaf baby's cord blood will be done via IV transfusion back into the child. Parents whose deaf children qualify for the trial study will decide whether to try the new procedure or not.

Since this news came out it didn't take long for an outcry in the form of a petition for culturally deaf people and others to decry the IV transfusion stem cell study as:

....inhumane and unethical and condemn this hospital, corporation, other collaborators and the FDA for treating our Deaf infants in this experiment as their guinea pigs.

The original petitioner went so far as to claim such procedure as dangerous and that it carries "long lasting risks" but never elaborated on exactly what those "long lasting risks" are. However, there is a similar but previous safety study using cord blood stem cells on children with cerebral palsy age 1 to 12 years old that began in January 2010. Final data collection on outcome ends in February 2012 which is next month.  Ironically, there appears to be no objection from any particular protest group for this IV transfusion safety study for babies and older on reversing their cerebral palsy condition.

The MCG team follows on the heels of a pilot study at Duke University which is exploring if cord blood can be readily applied to infant’s with palsy like symptoms in the first two weeks after birth. Both teams are looking to verify the anecdotal evidence that cord stem cells can be used to ‘cure’ CP children. If successful, the work at MCG and Duke University may provide parents with hope that storing a child’s cord blood could be an effective shield against cerebral palsy.

Cord blood IV transfusions have been done in children and adults.

To be safe, most cord blood transplants done so far have been in children and smaller adults. Researchers are now looking for ways to use cord blood for transplants in larger adults.

This first ever FDA approved study on hearing restoration (sensorineural hearing loss) for deaf children describes the study:

Acquired sensorineural hearing loss is characterized by a loss of functioning hair cells in the Organ of Corti, with greater hair cell loss correlating with more severe hearing impairment. Children with sensorineural hearing loss experience difficulty developing normal language which usually leads to poor academic and social development. Currently, there are no reparative therapeutic options available, and treatments are designed to augment the diminished function of the injured Organ of Corti.


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 (hUCB) is an available, autologous, stored progenitor cell population available for potential therapeutic use. The primary objective of this study is to determine the safety of autologous hUCB infusion in children with acquired hearing loss. The secondary objective is to determine if functional, physiologic and anatomic outcomes are improved following hUCB treatment in this patient population.

This may turn out to be a promising result since it says that pre-clinical data suggest that such a procedure may restore hair cells thus lead to hearing improvement. This is obviously a much more natural process, if proved successful, involving the baby's own stem cells from the baby's umbilical cord (cord blood) could ultimately turn out to be much better option than cochlear implants. In fact, if successful would shorten the prediction time scale to seveal years on a reversing sensorineural hearing loss instead of a few decades away. Over a year and half a ago in my blog I commented that in 2004 a prediction was made that an application for hearing loss rather than a cure could be at least twenty years away (or by 2024) by Dr. Rubel. In another article in 2004 Dr. Rivolta said a cure could be possible in 10 to 15 years away (by 2014 to 2019). In 2009 in the Department of Otolaryngology University of Miami Ear Institute's newsletter quoted believing they could be 10 years away (or 2019) from a cure at the earliest possible timeline. But most scientists seem to concur that a cure or a very applicable treatment on reversing hearing loss would be seen within their (the scientists') lifetime...and that's not very far off folks.

Cure for nerve deafness gets even closer

One step closer on the goal to help restore hearing loss.

A cure for deafness could be on the horizon after scientists created specialised ear cells in the lab.

Grown in their thousands, the delicate hairs could one day be transplanted into the inner ear, restoring hearing to millions.

The breakthrough comes after ten years of painstaking research.

It may also allow some balance disorders to be eased and aid the search for drugs to prevent people from becoming hard of hearing.

Age-related hearing loss affects half of Britons aged 60 and over and there is currently no way of holding it at bay.

Hearing aids amplify sounds but nothing can give sufferers back the hearing they once had.

In the latest research at Stanford University, California, scientists perfected turning stem cells - blank cells which can turn into other cell types - into the delicate hairs found in the inner ear. ones.

The linch-pin of hearing and balance, thousands of these hairs help convert sound vibrations into nerve impulses which are decoded by the brain.

Ageing, noise and general wear and tear make them wither away and, until now, there was no way of replacing them.

The hairs made in the lab from mice looked and acted like the real thing, the journal Cell reports.

Researcher Stefan Heller said: 'We knew it was really working when we saw them in the electron microscope.

'They looked more or less like they were taken out of the ear.'

If the same technique can be applied to human cells, within ten years it may be possible to transplant-the delicate hairs to restore hearing.

Using slivers of the patient's skin as a source of the stem cells means that any hairs generated would be a perfect match for their body.

It also raises the tantalising possibility of creating drugs to coax the ear into growing more hair cells of its own accord.

We may be only 10 years away on witnessing the impossible.

Read more: http://www.dailymail.co.uk/health/article-1278160/Deafness-cure-breakthrough-scientists-create-tiny-ear-hairs-stem-cells.html#ixzz1MIzLjDfu

Addressing deafness in the field of regenerative medicine

From the medical journal "The Development of a Stem Cell Therapy for Deafness":

Medicine is at the doorsteps of a phenomenal revolution, brought by the advances in the stem cell field and the development of new technologies to engineer cells and tissues into more complex organs. The promise of a true regenerative approach to organ damage and loss of function is closer than ever of becoming a reality. The auditory field is participating of these developments with high ­expectations. Since the cochlea is an organ of difficult access and with very limited regenerative capacity, conventional therapeutic approaches have failed and, currently, the only treatments available are in the form of hearing aids and cochlear implants. The potential restoration of hearing by the use of exogenous stem cells will offer a solution to a condition that has very limited options. In this chapter, we are reviewing the increasing volume of research on this emerging field and discussing the key elements that need to be developed further, in order to translate the basic science into a clinical reality.

Take a peak inside and read a few pages from the Regenerative Medicine journal on how far along stem cells are and how close the reality is on restoring hearing loss using stem cells.

Could your nose help restore your hearing loss someday?

Don't pick your nose! You just might ruin your chance on the cure of your hearing loss someday!

Ok.

Seriously.

That won't happen.

I mean, the nose picking part. But news came out a few weeks ago on stem cells in the nose could provide a potential source of adult stem cells to harvest that can be used to help restore hearing loss in the cochlea from that same person's own nose.

The findings, published in the journal STEM CELLS, found that transplanting mucosa-derived stem cells, a form of rapidly renewing tissues in the nose, can help prevent sensorineural hearing loss during its early stages.

Scientists transplanted adult human nasal stem cells into the ears of mice that exhibited signs of hearing loss. The mice were 4 weeks old, the typical age when hearing loss in mice first becomes apparent. Dr. Sharon Oleskevich, lead study author from the Hearing Research Group at The University of New South Wales, said her research team found improvements in hearing function one month later when compared against age-matched mice that received placebo injections.

It has been demonstrated in a number of studies that stem cells, such as olfactory stem cells, dental pulp stem cells and hair follicle stem cells have the ability to transform into functional cells of the nervous system," Dr. Christian Drapeau, chief science officer of Stemtech International, told AOL Health. "For example, in animal studies, injection of hair follicle stem cells in the spinal cord was able to restore mobility."

He says the olfactory stem cells injected in the cochlear cavity could help reverse or protect sensorineural hearing loss in the same kind of way.

"Examination of hearing levels one month post-surgery demonstrated that hearing thresholds in stem cell-transplanted mice were significantly lower than those of mice that received a placebo injection, indicating that transplanted mice were better able to hear less-intense sounds," Oleskevich told AOL Health in an e-mail.

Doctors and researchers are optimistic their research could impact future treatments of hearing loss.

Who knows? Maybe they got something going there?

Need a hanky, anyone?

Stem cells to repair hearing loss in nine years from now

A bold prediction has come in. In nine years prediction of stem cell procedures will become available to help regrow or repair hair cells in the ear to help people regain their loss of hearing isn't too far off.

Regeneration of hearing abilities and teeth – Deafness is a result of malfunctioning or damaged cochlear and vestibular hair cells that are found within our inner ears. It might be possible to repair or re-grow these hair cells through inducing stem cells with proper stimulation. Although it is a success with mice already, human beings might have to wait till the year 2020 to actually benefit from this method.

In only 9 years from now, imagine that folks. And then begin the procedures for babies born with a hearing loss by reversing it. Then cochlear implantation will no longer be a controversal proceed because it would become outdated and old in favor of a new medical procedure that'd be more effective.

Only time will tell.

Adult stem cells from adipose tissue accidentally improves hearing in one patient

Or so it seems if one read this recent medical article.

In May 2008, the patient was treated with two I.V. infusions of 28 million SVF cells and multiple intrathecal and intravenous infusions of allogeneic CD34+ and MSC cells. MSC were third party unmatched and CD34 were matched by mixed lymphocyte reaction. Infusions were performed within a 9-day period and were very well tolerated without any adverse or side effects. No other treatments were necessary during the patient's stay. After the second stem cell infusion the patient reported a significant decrease of his generalized pain. However, he continued to experience severe neck and shoulder pain and was re-evaluated by his neurologist. Two months after the stem cell therapy, the volume of his hearing aids had to be lowered once per week over 4 weeks. Three months after the stem cell infusions the patient reported a significant improvement of his cognition and almost complete reduction of the spasticity in his extremities. He mentioned that he has had 623 tonic seizures in the past and confirmed that he has not experienced any more seizures since the completion of the stem cell therapy. A neurological evaluation performed three months after the stem cell infusions revealed an intact cranial nerve (II-XII) function and no nystagmus, normal motor function without any atrophy or fasciculations, and intact sensory and cerebellar functions and mental status.

Could your own stem cells in your hair follicles help you hear someday?

From the October 2009 22ND IGB MEETING STEM CELLS: FROM MOLECULAR PHYSIOLOGY TO THERAPEUTIC APPLICATIONS:

Adult stem cells in your hair follicles seen as a potential source that could differentiate into auditory neurons.

Stem cells from the hair follicle differentiate into auditory neurons. Margriet A. HUISMAN, Ragad El Seady, Johan H.M. Frijns

Department of Otorhinolaryngology, Leiden University Medical Centre, The Netherlands To patients suffering from profound sensorineural hearing loss, cochlear implantation(CI) is currently the standard approach. Most implant recipients experience benefits, however, understanding speech in noisy circumstances and music perception remains challenging. It is suggested that stem cell-based therapy, by increasing the number of auditory neurons (ANs), will improve the performance of a CI1.

Stem cells, derived from the bulge of hair follicles from adult mammalian dermis (epidermal neural crest stem cells, EPI-NCSC), are potential candidates for AN regeneration: they have a similar origin as inner ear cells, their functionality has been proven and autologous transplantation is possible, avoiding graft versus host disease2,3. The aim of this research is to investigate whether EPI-NCSC have the capacity to differentiate into neurons with features of auditory neurons, such as bipolar morphology, presence of TrkB/C and GluR2/3 and sodium voltage channel 1.6 (NaV1.6)4. EPI-NCSCs from whiskers of mice were expanded and differentiated on a collagen I matrix. Subsequent t o proliferation, quantitative immunohistochemistry was performed to demonstrate the presence of neural stem cells (nestin). In addition, expressions of TUJ1, TrkB and -C, GluR2/3 and NaV1.6 were determined.

After the proliferative phase, the majority of the cells (90%) were positive for nestin. The average yield per follicle was 2x105, while for inner ear transplantation purposes 2-5x105 cells are required. 70%±8% of the differentiated cells was positive for the neural marker TUJ1. Moreover, 60%±2% of the neurons showed a bipolar morphology and the majority was positive for GluR2/3 and NaV1.6 and showed co-expression of TrkB and –C. EPI-NCSC-derived neural stem cells can easily be obtained in quantities sufficient for inner ear transplantation purposes. These stem cells have the capacity to differentiate into neurons with hallmarks of functional AN, which makes them promising candidates for a stem cell-based therapy of the auditory nerve.

Who knew? Adult stem cells from your own hair follicles have the potential and capacity to help restore your hearing loss. Problem is, bald guys are out of luck.

Checkmate?

I read kmayes response that she noticed an interesting thing regarding the news of an 18 year old woman who received her own adult stem cells treatment saw her hearing loss improve dramatically.

I noticed one thing… a total silence from the people who are involved in advocating for audism, DBC, etc… no comments from them (I am sure they lurk here though.)

Interesting.

I think all this is an understatment on what's going on here. More like an exclamation point and some just don't want to deal with that fact. Hence, the literal silence.

Here's the captioned video about the story of that 18 year old woman who may be in fact the first American to have her hearing loss nearly restored with the help of her own adult stem cells.
Why are the Deaf bloggers so quiet on this? If it were a cochlear implant thing they'd be all over it like a moth to a flame because it's a topic they've become well accustomed to and are comfortable in dealing with it, even acceptance. But what about the story on this adult stem cells successful treatment (so far) on an 18 year old deaf woman who was once hearing is now close to her former self? Doing a blog Google search hardly show any Deaf blogs that have covered the breaking story. Not hardly but none is more like it but save a few.

Perhaps they are still digesting the story? Perhaps so even though many believed just a few months ago that a cure or successful restoration (partial or otherwise) wouldn't happen in another few decades away find suddenly themselves confronted with the fact that it happened just last month!

Adult stem cells research and application for the restoration and cure for nerve deafness are fast approaching and becoming a reality. There is no way this can be compared on the level of cochlear implant which was a source of scorn and distrust for over 20 years. According to the video it appeared that using your own adult stem cells has seemingly proven to be safe and effective compared to embryonic stem cells and cells donated from other people for use. Perhaps the Deaf community doesn't want to talk about this success extensively so because looking at the chess board seeing that they've been "checkmated"? After all, how can you compete against 33+ million people with hearing loss with the majority of them due to nerve deafness who will welcome this successful adult stem cells treatment for hearing loss. Even Gamas Wanderings' own poll showed that approximately 60% of those who voted would take or might take the adult stem cells cure over those who would not. That's pretty telling. Funny how people thought cochlear implant was bad enough, we now have a very real possibility in the very near term well within our lifetime to see that nerve deafness hearing loss would become a thing of the past once this adult stem cells treatment begin to ramp up and that 2009 is the turning point.

Checkmate?

Or not?

You decide.

Will Deaf Culture Die Out Someday? - Part II

If you want a quick recap on "Part I" piece go to my September 19, 2009 blog. Here, I just wanted to respond to "Souggy's" blog claim that I "was proud of that 'fact' " that Deaf culture is dying, which was an irresponsible comment on his part and showed an attempt to twist words here.

I was reading a blog that Deaf culture was dying because of cochlear implants and stem cells; and apparently the blogger (or so-called pundit) was proud of that “fact,” which was the reason why I published this blog post.

There is a caveat at the very beginning of my blog "Will Deaf Culture Die Someday? " in my first paragraph.

There is always a possibility that Deaf culture could die out and this is dependent on a variety of factors with some of them going against the spread of Deaf culture and its language, ASL. But at this point it's probably more of a matter of "if" and not "when."

It's pretty clear what I wrote was a matter of "if" and not when.

I'm pretty sure Souggy was referring to my blog piece since he commented about "a blog" he read and that mine was dated September 19, 2009 while his blog piece was on September 20, 2009. And what was interesting was that he never bothered to make clear who he was referring to. No link or names. I wonder why? Rather curious to try and hide it like that.

Secondly, there is nothing in my blog indicating I was "proud of that fact" that Deaf culture is dying because of cochlear implant and stem cells. If "Souggy" actually took the time to read what I wrote it was discussed in terms of a possibility, and not a fact that it will happen. In my blog piece there is nothing said or implied about being proud to see Deaf culture die out. It was irresponsible of "Souggy" to say such a thing. I presented a scenario that because of technology and the advancing biotechnnology could get to the point where it could heavily influence and impact the Deaf community in ways not seen with hearing aids and cochlear implants, and how it could affect mating preferences among deaf and hard of hearing people over time.

Stem cells strategy for hearing loss cure...a captioned video

Blinded by my own hearing

Not me but I was pleased to hear David Granovsky's comment in his blog "The Stem Cell Blog" when he covered the Chloe Sohl's story on her miraculous recovery from her hearing loss using her own adult stem cells. David went onto say that basically he forgot about people with hearing loss may unable to hear or understand fully what the original YouTube version of Chloe's story. And that he was "blinded" by his own hearing for not thinking about a captioned version of Chloe's video story.


Related Kokonut Pundit blogs on adult stem cells and hearing loss.

Video Interview (caption) with first American to have her hearing loss restored

Not fully restored so far but it looks like Chloe's hearing is on the mend already since this adult stem cells procedure began only a few months ago. Watch the video about a story that is probably the first case of an American woman that was successfully treated with her own adult stem cells to treat her hearing loss caused by her auto-immune resonse.




More info on the story.


YouTube's version without captions.

First Successful Case Example of a Hearing Loss Cure in a Human Patient?

With the slow progress and FDA approval in the United States on using stem cells to help treat nerve deafness hearing loss a patient with autoimmune condition hearing loss was treated in South Korea using her own adult stem cells that eventually restored her hearing to almost normal levels.

Chloe visited Dr. Won, a plastic surgeon in Los Angeles to harvest her fat tissue around her belly button in last June. Then the tissue was sent to the laboratory RNL BIO in Germantown, Maryland, where they isolated stem cells, put them in liquid nitrogen shipper and transported them to RNL BIO in Seoul, Korea. It took them a month to expand her stem cells to a sufficient amount enough to treat her hearing loss. Chloe's family planned a trip to Korea during their summer vacation. At last, on July 27, 2009, they visited Korea for two weeks. The stem cell treatment took place in Japan -- 600 million cells were administered by three injections with 5 day intervals. The cells were injected into her veins and auditory system.

Chloe's hearing was tested two months after the procedure was completed on October 16, 2009. The results were spectacular. The left side of her ear improved 50% from not being able to hear at all. The right side of her ear gained almost complete hearing.

Dr. Jotterand could not bear her excitement, "Now it's just been a 180 degree turnaround. She's just enjoying life and enjoying being a freshman at the university. She's just having a great time and it's just wonderful to see the joy in her own face and in her life."

Again, with a grain of salt but this looks more promising. With more countries such as Mexico taking part in using stem cells to began the treatment of nerve deafness hearing loss, the United States will surely be left in the dust at this rate unless the FDA somehow fast track this medical process just as they have fast tracked for the treatment of damaged heart muscles with the patient's own stem cells.

Hat tip: Neuro.

UPDATE: See caption video interview of Chloe!