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SkinTE Hair Regeneration in Full Thickness Wounds


#1

I’ve been following this for a few months.

They just completed registration with FDA yesterday and it may now be used in the US.

http://www.polarityte.com/news-media/press-releases/detail/413/polarityte-announces-fda-registration-of-lead-product-

It apparently regenerates full thickness skin including all appendages… sweat glands, sebaceous glands, and…HAIR.

So uh… If it completely regenerates hair in full thickness wounds (donor area) would that not allow for unlimited donor hair with no awful scars afterward? Is this is a huge deal or am I missing something…?


#2

Edit: Just saw some forum users were discussing this a few months back.
But now, it is officially FDA registered! Already! For once, this isn’t something that years or decades away… It is here now!


#3

omg thank you so much for posting this I did read about this on this site a while ago and dreamed someday soon something like this would become available, even after yrs of scar revision and hair planted into the scars and tens of thousands of hard earned dollars spent I was still forced to wear a hat all the time, it literally destroyed my life again very grateful to you for posting this hopefully a doctor will begin utilizing this soon, i would literally travel wherever need be to get this done


#4

I don’t know how they could implement this technique to grow new hair.


#5

It’d be a mastery of current hair transplants. You take your donor strip as usual, but instead of sewing it up and giving you a monster scar, you apply SkinTE, it regenerates the area fully (along with the hair that you took) and (if it works) it looks like you never had the procedure at all. It heals up good as new. Then, if you need more hair for the top, you simply wait for the healing process to be complete and for the donor area to return to pre-operation normalcy, and you repeat the process again. Hypothetically there’d be an infinite number of donor hairs and an elimination of scarring. Effectively eliminating all of the pitfalls of hair transplants.


#6

Yeah, we could ask if this technique works or how would this be implemented, but it surely gives hope.


#7

Why bother moving donor hair from the back, and then using skinte to regenerate skin and hair in the back.

If it works, wouldn’t it be simpler just to cut bald scalp off the top of your head and apply skinte to the top of the head?


#8

Because there’s some biological mechanism that we don’t fully understand that causes the hair on top of our head to fall out. I don’t see any reason why the newly healed area would be any different? If hair did grow back then it would be hair that was biologically identical to previous hair that was on our head. Making it susceptible to the same biological process that attacked those hairs in the first place. The hairs on the back of our head are immune to the process though, as we know, since hair transplant hairs don’t fall out, so why not play it safe and use those? We already know they work.


#9

While the video claims the regenerated skin contains hair follicles, how do we know those follicles will produce real terminal hair and not some kind of peach fuzz?


#10

I guess we won’t know for sure until they post their results on humans.
If it regenerates full thickness skin and all of it’s appendages though, I don’t know why it’d be peach fuzz!
Also, the pictures on their site of the pig models shows hair that looks identical to the area that wasn’t wounded. We should know very soon if the same results translated into humans. Seems promising, again, due to all of their recent activity. But we will see…!


#11

If this can really reproduce hair with terminal follicles, this is our answer. However, I don’t believe that particular claim. We have actually heard that claim several times before from tissue engineering startups, such as the group in Toronto that was claiming that several students had invented a 3D printer that could print hair-bearing skin. It turned out that wasn’t the case.


#12

Totally understand your skepticism and I’m right there with you.
This one has me a little more intrigued than others though just based on the way it has been moving. It’s made by a team of prestigious surgeons that left Johns Hopkins because of their confidence in it. They just bought a 21 million dollar facility last week for the company. They sped through FDA approval with SkinTE when the vast majority of the others that make this claim never get anything out of the preclinical stage, even in this approval they continue to voice their confidence that it will change medicine along with their other regenerative medicine platforms. We’ve heard claims before, many of them, but this one definitely stands out form the others. Maybe they are lying, but it’d be a damn good lie!


#13

I want this to be true, but I don’t think it is exactly what they’re describing. I think that if technology was developed to replicate living skin with brand new hair, it would be bigger news than this. Also, I think they’d be advertising this as a cure for hair loss right now, because of the size of the demand – rather than just something for wound repair.

The fact that they aren’t advertising it as a cure for hair loss suggests to me it’s not… it may be a way of expanding hair-bearing skin at a wound site, so you get a bigger area of skin with hair that can cover a wound, without actually creating new hair follicles. So, if they’re saying something like “new skin with hair”, that doesn’t mean “new skin with new hair” – it just means a larger area of skin with the same hair you had before.


#14

I too have wondered why it’s not bigger news. But I think they’re kind of intentionally engineering the rollout as such. They have stated that they are currently doing a ‘controlled, limited release to select medical institutions’ and plan to rev up a full scale commercial release in 2018. Maybe that’s when they plan to get in touch with the media and things will really blow up…?

I think first and foremost it is a treatment for wounds. That’s what it was created for. And it was just cleared for usage in the past week, which may be why they’re not advertising it in other ways just yet. Though, if you follow their facebook page, they have given this response on a couple occasions - ‘Thank you for your interest in SkinTE, currently in development for application in the wound and burn market to regenerate full-thickness, fully-functional skin. We are planning for clinical application in Q3 2017 and market entry by 1H 2018. If successful, we plan to explore entry into other markets such as acute and chronic wounds, cosmetic/scar revisions, and hair regeneration.

The hair regeneration part obviously being the notable portion. Interesting question you propose though - new hair, or new skin with the same hair you had before? I am inclined to say that for a full thickness, 3rd degree burn, it’s not just the skin that is damaged while the hair follicles stay in tact. If the skin has a full thickness burn, those hair follicles and other appendages are going to be greatly damaged or totally destroyed as well. So if SkinTE enables their existence post 3rd degree burn, I’d have to think they’d be newly regenerated ones…? Just my guess though, who knows!


#15

That news that they see an application in hair regeneration is definitely encouraging. Thanks for that news!

But, I think we have yet to see what stage of development they’re in. On the video, they make it SOUND like a finished project, but there in that Facebook response, they say “currently in development.” Which makes me think that they still have a bit of research to do. They say they passed some milestone with the FDA, but exactly what was that milestone? Approval of a finished product, or just clearance to go ahead and test it clinically?


#16

The quote I listed was taken from some Facebook comment responses a few months ago. Before the FDA milestone last week! So the ‘currently in development’ portion is a bit outdated, now! They have definitely gained clearance to use it clinically. But have chosen to do so in a smaller, selective, controlled setting before going full on commercial early next year. The product is an HCT/P, meaning it uses human cells, tissues, or tissue-based products. So to my knowledge that is what enabled them to get it FDA registered so efficiently. Far less hurdles to jump through than a new drug, for example. Maybe for an HCT/P product a pre-clinical test is enough to get it FDA registered, maybe this small, controlled rollout is when they will really put it to the test as far as human patients - I really have no idea how it all works. But, again, with their recent displays of confidence, I feel like they know something. Something is inspiring this confidence. I mean - highly skilled surgeons from one of the most prestigious hospitals in the world up and quit their jobs and purchase a $21 million facility aligning with the FDA approval of their product and continual verbalization that this is going to revolutionize medicine in the next few months?!.. I don’t know. To me, they must have seen what this can do… Could be wrong, but I’m just saying - it’s looking pretty good?


#17

So this is still somewhat invasive because you need to take donor strip as usual, like going in for a strip hair transplant?


#18

Hypothetically, yes. If they perform the treatment in the way I described above - but that is merely my speculation on how it could be used…


#19

It’s actually no more invasive than what Dr. Kemp is doing at HairClone (albeit in a very experimental way), or what Replicel is doing. If you want to do any kind of tissue engineering to regrow hair, you are going to have to provide donor cells through a tissue biopsy. I think there’s no way around that.


#20

Good question. No idea ar this point, and I wish we could have an interview with one of the founders to answer things like that.