Stem Cells Restore Toddler's Congenital Hearing Loss

In a potentially revolutionary treatment, a two years old toddler born deaf has had her hearing restored after receiving stem cells from her banked umbilical cord blood. (Reported in ABC News)

Madeline Connor at age 1 year old was completely deaf in the right ear and had severe hearing loss on the left. Normally hearing aids or cochlear implant would have been the only options.

However, in January 2012 at the age of 2 years old, Madeline underwent a "simple" experiment whereby stem cells were infused into her damaged inner ear. The stem cells were derived from umbilical cord blood that was banked at the time of her delivery at the Memorial Hermann-Texas Medical Center.

Over the next 6 months, there has been dramatic improvement in her hearing. She is also now talking for the first time.

Madeline also is not the only child who has undergone this revolutionary stem cell treatment. Apparently, there are ten other children who are being followed after undergoing similar stem cell infusion derived from banked cord blood.

It must be stressed that though Madeline's progress is quite amazing, it is still too early to say if this is a "bona fide" treatment for congenital hearing loss.

• Will the improvement continue and more importantly, last over years to decades?
• Will it work for other children?
• What is the expected hearing improvement with stem cell infusion?
• Will it treat ALL forms of nerve-damaged hearing loss?
• Does it have to be stem cells derived from cord blood or are stem cells derived from other sources possible (i.e., skin)?
• Can adults with non-congential hearing loss also benefit?

I eagerly await the outcome of this FDA approved trial which hopefully will be published at some point in the near future.

I also eagerly await the protocol used to obtain and infuse the stem cells. I suspect the infusion of stem cells is similar to that done when steroids are infused into the ear for sudden hearing loss as shown in this video below. However, this is just a guess of mine.

Source:

Cord Blood Stem Cells Restore Toddler's Hearing. ABC News 7/11/12

Government Sponsored Studies Not Getting Published

Yale researchers published a study on whether NIH-funded studies get published after research completion.

The researchers examined all clinical trials after Sept 30, 2005 funded by NIH and registered within ClinicalTrials.gov maintained by the US National Library of Medicine.

Shockingly, among 635 clinical trials completed by 31 December 2008, only 46% (294 studies) were published in a peer reviewed biomedical journal within 30 months of trial completion. The median period of follow-up after trial completion was 51 months (25th-75th centiles 40-68 months) and 68% (432) were published overall.

Why aren't more of these completed studies being published???

It was already known that industry-sponsored studies had only a 40% publication rate. One can rationalize that such pharmaceutical-sponsored studies that do not reveal promising results do not get green-lighted for publication, but such a bias should not technically occur with government sponsored trials.

However, it just may be that there may be political pressure that may influence whether one study gets published and another does not (much like what has happened with climate research which allegedly has gotten smothered by unfriendly political forces).

It is also possible that researchers just do not prioritize publishing being more interested in doing the research and not so much the writing up of their results... OR their research findings have gotten rejected by journals for publication.

OR... maybe the unpublished studies are just THAT bad such that the research is literally unpublishable... which I find hard to believe given getting NIH grants to do the research is difficult and highly competitive.

In any case, there MUST be more effort to publish research findings for many reasons, key among them being:

1) Even if the study shows no results, that in itself is meaningful (if a drug did not work, than everyone should know that)

2) Duplicate studies would not occur which one can argue would be wasteful. Why reinvent the wheel when it already has been done? (there is a role for repeating studies, but should be done in a setting of being AWARE of repeating the research)


Reference:
Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012 Jan 3;344:d7292. doi: 10.1136/bmj.d7292.

Publish or... Don't. Yale Alumni Magazine. Page 32. March/April 2012.

Best Drops for Earwax Removal

It's about time, but some researchers actually put to the test to try and determine what is the best solution to dissolve/remove earwax.

The verdict was... WATER!

Better than mineral oil, liquid colace, and over-the-counter cerumenolytics (ie cerumol). Hydrogen peroxide was not evaluated.

How was this result determined?

Using guinea pigs, the researchers first tested whether each of these substances were safe should a hole in the eardrum be present allowing for the solution to enter the middle ear space. Colace was found to be the most ototoxic (meaning, potential for permanent hearing loss if a ear tube or a hole in the eardrum is present). Mineral oil and saltwater (normal saline) was found not to be toxic.

Next, they determined which substance provided the greatest degree of cerumen dissolving ability. Each substance was added to a cylinder filled with earwax for 5 minutes. They than determined how much weight was required for a 25G needle to fully penetrate through the earwax.

Water was found to provide far superior earwax dissolving ability compared to all other substances tested.

What is the take-home message?

Given saltwater is completely safe for hearing even if there is a hole in the eardrum along with superior earwax dissolving ability, it seems to be a no-brainer to instruct patients with lots of earwax to use salt-water to get rid of earwax.

Reference:
Ototoxicity of intratympanic docusate sodium and mineral oil in the Guinea pig. Otolaryngol Head Neck Surg. 2012 Mar;146(3):455-60. Epub 2011 Nov 18.