2 hours ago, Candy Says said:6 hours ago, Rez77 said:And I was right. I actually do know a lot about this shit from years of research.
what should scientist do to achieve complete regeneration?
We should all take the moderator's advice and just ignore Rez77.
To fill in those curious about the hydrogel, I actually spoke to Dr. Sun directly and posted the convo in a private thread. He achieved what he called "perfect skin" in pigs but is choosing to go through clinical trials in humans to prove its efficacy. He also said that he will likely need to optimize the product for humans because nothing goes "0-100." On top of that he needs a lot of investment money to just conduct trials. His research is not vague or ambiguous and the entire paper was free to read over the last quarter of last year. It's just extremely hard to get that kind of money if you're not working on a commercial product. It's a catch-22investors want results that only the trials can give you, which of course you need the money for in the first place.
This is why any suspicions I had about PolarityTE going public so soon were tempered greatly by the fact that it just made more sense. If you can (and they can because they fall under the 361 regulatory pathway of the FDA) become a company with an actual product as soon as possible far more investors will be enticed by that setup than a researcher conducting trials. Of course someone (and many on here have) could equate that to a get rich quick scheme but for me it just was a smart business move.
7 hours ago, sousou_bella said:Just an update - I reached out to the Dr. in Tennessee. His nurse said that he currently uses TE on patients (mostly patients with burns as they work in a hospital). She told me to email my pictures and give an explanation of what treatments Ive already had. He got back to me last night and said that he feels that it is too early to recommend SkinTE on my scars. I asked him why that was since from what I gathered they already achieved regeneration of all layers of skin in human applications. I will let you all know what he says. Im now going to contact another clinical advisor and just go down the list that way to see if anyone would be willing. If that doesnt work, I will then reach out to Dr. Shaw Im Virginia. Hope this was helpful.
Great work!
Pretty much as Sniffy saidthis is an expected response when there are no results. Just to clarify, there haven't been any results released on humans so it's unknown what level of regeneration it achieves in us.
I'm assuming it's Dr. William Hickerson you got in touch with at Tennessee. I wonder if he'd share any initial observations he has about the results thus far. I doubt he'd be willing but could be worth a shot.
Regardless, nicely done! The more proactive members of this board are the less guess work.
11 hours ago, sousou_bella said:He got back to me last night and said that he feels that it is too early to recommend SkinTE on my scars. I asked him why that was since from what I gathered they already achieved regeneration of all layers of skin in human applications.
I would say they are just uncertain on how effective Skin TE will be on humans at this current stage. Most likely more time is needed. They achieved full regeneration in pigs, not humans.
If they did achieve regeneration of all layers in humans, the stock would be $100 + bucks. There is no proof of that yet in humans.
Enter Rez in 5,4,3,2,1....
11 minutes ago, Candy Says said:I wonder if someone need full face to be treated by skinte, I mean from ear to ear and from forehead to neck, where would they take skin to perform graft? Not from ass, right? from lower back or where?
@sousou_bella you would be a true hero of you'll push him to apply this product on your scars. Im not advising it, and would not do it for myself, but honestly Im shame to admit that I would like to see it if you will do it. Sorry.
good thing that he didnt totally refuse to do it or even mention it with his scars. @sousou_bella you have atrophic acne scars, right? sorry if I didnt notice your condition in your previous posts
I had read on this forum that regenerated skin using SkinTE is supposed to take on the skin properties of surrounding skin. I also read that the regenerated skin will take skin properties of the skin biopsy, so it won't be ideal for acne scars if you take a skin graft from the lower back and excise those atrophic facial acne scars to treat them with SkinTE. We don't really know at this point.
6 hours ago, Anonymouz1 said:6 hours ago, Candy Says said:I wonder if someone need full face to be treated by skinte, I mean from ear to ear and from forehead to neck, where would they take skin to perform graft? Not from ass, right? from lower back or where?
@sousou_bella you would be a true hero of you'll push him to apply this product on your scars. Im not advising it, and would not do it for myself, but honestly Im shame to admit that I would like to see it if you will do it. Sorry.
good thing that he didnt totally refuse to do it or even mention it with his scars. @sousou_bella you have atrophic acne scars, right? sorry if I didnt notice your condition in your previous posts
I had read on this forum that regenerated skin using SkinTE is supposed to take on the skin properties of surrounding skin. I also read that the regenerated skin will take skin properties of the skin biopsy, so it won't be ideal for acne scars if you take a skin graft from the lower back and excise those atrophic facial acne scars to treat them with SkinTE. We don't really know at this point.
no who told you it takes the properties of the skin biopsy it takes the lgr-5 lgr-6 stem cells from the skin biopsy
According to their 10-K at least, they're trying to get it as close as possible to the original skin:
QuoteWith SkinTE, often within 24-48 hours of the initial skin harvest, our product is applied to the patient, whose body then provides a receptive environment and nutrients for controlled healing. By both preserving the tissues natural microenvironment and using the patients body as an intrinsic bioreactorwhich means using the bodys own natural biological healing process rather than a manufactured or engineered environment to support the regenerative processwe believe a patients own tissue can be regenerated, along with its natural coloring and texture, layers and structure, hair and appendages. We have designed our technology platform to use the patients own healthy tissue, in part to increase the likelihood that the patients immune system will identify the regenerating tissue as its own so that our product is neither rejected nor reacted to adversely. We believe that our platform has the potential to transform tissue regeneration, including potential regeneration of multiple tissue substrates, such as skin, bone, muscle, fat, cartilage, nerves, and blood vessels. The harvest, deployment, and application of our platform technology in SkinTE is shown in the images below.
https://ir.polarityte.com/press-releases/detail/419 Another update from Polarity. Nothing concrete, but seems promising.Let the analysis of wording begin:)
4 minutes ago, eekman said:https://ir.polarityte.com/press-releases/detail/419 Another update from Polarity. Nothing concrete, but seems promising.Let the analysis of wording begin:)
Haha, yes, it will begin. Still early in the wound healing so there's probably no way to tell if it's complete regeneration yet and obviously there is certainly no way to tell what the final healing result will be. Very encouraging that the doctor wants to use it on the rest of the child's scars.
Please though, please, let this put to rest the silly notion that the product isn't available and being used.
54 minutes ago, golfpanther said:Haha, yes, it will begin. Still early in the wound healing so there's probably no way to tell if it's complete regeneration yet and obviously there is certainly no way to tell what the final healing result will be. Very encouraging that the doctor wants to use it on the rest of the child's scars.Please though, please, let this put to rest the silly notion that the product isn't available and being used.
I am not sure how skin te will be used to treat acne scars now, until and unless they create a dermal injectable filler. Very few scar doctors use excision to treat acne scars and even then it will take few months to heal.
30 minutes ago, Binga said:I am not sure how skin te will be used to treat acne scars now, until and unless they create a dermal injectable filler. Very few scar doctors use excision to treat acne scars and even then it will take few months to heal.
Well, to be honest SkinTE as it is now was not designed for acne scars or any cosmetic scars for that matter. It was made to treat 3rd degree burns primarily so their press release shouldn't have changed much about your views on that.
A lot of doctors use excision for acne scars, but yes, not as many that use lasers, peels etc. PolarityTE has always stated that they plan on creating derivatives more suited for the cosmetic market. That being said, if the final stage healing results are what they got in pigs, or close to it, I guarantee you that there are doctors out there that would us SkinTE as is for cosmetic purposes. Honestly though, I would think it would be prudent to be a little patient and see what their derivatives are like. That's just me though.
47 minutes ago, Frasier said:Positive news - but still very vague. If SkinTe works as we hope I think dermabrasion + SkinTE will do the job for most people. I might be completely wrong though.
Definitely vague, but it will be until the results are final. I do like that the doctor feels that the healing is dynamic and improves over time. Obviously the pigmentation point is great news for burn sufferers and us as well because that means it's regenerating tissue that looks like normal skin; to a degree anyway.
QuoteUpon review of initial SkinTE results in humans, C. Scott Hultman, MD, MBA, FACS, the Ethel and James Valone Distinguished Chair ofPlasticSurgery, Chief Emeritus and Professor, UNC Division of Plastic Surgery, said, "Having reviewed some of the preliminary in-human clinical results, I am impressed with the degree to which the melanocytes have repopulated the wound, restoring pigment where it was once absent. Furthermore, there appears to be dynamic healing: the texture and biomechanics of the grafted areas appear to change over time, during the early phases of wound healing, for the better. I am very excited to see the long-term clinical results, when available. Polaritys SkinTE may be the first real option we have for truly bioengineered skin replacement."
From my reading of this, there is some form of "regeneration" going on, as the texture and "biomechanics" are said to be changing. I'm not 100% certain about what "biomechanics" is referring to, however.
2 hours ago, DinkumFridge said:good news. I would like to have a derivative that can be used for face scars sooner or later. I think I can dressing or injecting after the laser. I want to use skinte in other ways.
yeah I agree cut your face and put a paste on it it doesn't sound good and you cant go to public with it as they said the paste of skinTE can propagate into a scar maybe an injectable paste does the job
Yeah would be interesting to know if this could be applied after (for example) Fraxel re:pair or microneedling. The question is if it is still possible to resurface the skin if you dont need all layers of your skin back.
And by this mysterious margin, is it possible that this margin is quite visible like a normal. healing of a 2nd degree burn? When my niece was 3 years old she had a very bad burn. Dont know which degree but the upper layer was completely removed. After many months her skin grew perfectly back but between the old and new skin there is still a margin visible.
The problem with polarity TE is that nobody knows how the results are. Always very vague statements. Some of you talk about microscopic visible margin. This would be great, even if it is slightly visible.
They have something really strong. Otherwise I cannot understand why they are so damn confident.
5 hours ago, damnBOY said:yeah I agree cut your face and put a paste on it it doesn't sound good and you cant go to public with it as they said the paste of skinTE can propagate into a scar maybe an injectable paste does the job
Swanson definitely mentioned an injectable during my call with him, but honestly (and I've written this before) I have no clue how that would work.
SkinTE as it exists now needs 2 things: 1. a skin biopsy of healthy tissue and 2. an excised wound bed into which the paste is applied. A pure injectable paste doesn't seem to have either of those things.
Perhaps you'd still get the skin biopsy (so it's still an autologous/homologous product), but then the procedure would already be so invasive it wouldn't really be providing much of a difference.
It's key that whatever the injectable is maintains its autologous/homologous (from patient/for patient) properties. If it doesn't (i.e. they create the paste in a lab as a one product for all type thing), I don't think they could qualify for the the 361 regulatory arm of the FDA, which would likely result in needing to put the derivative through trials. Swanson also discussed an over-the-counter solution, but hinted that it would probably need a different regulatory pathway.
Perhaps they could find a way to take the cells from your body without a full skin biopsy. To clarify, I have no idea, but I do think the derivatives might take longer to iron out than we'd like.
2 hours ago, royaume said:Yeah would be interesting to know if this could be applied after (for example) Fraxel re:pair or microneedling. The question is if it is still possible to resurface the skin if you dont need all layers of your skin back.
And by this mysterious margin, is it possible that this margin is quite visible like a normal. healing of a 2nd degree burn? When my niece was 3 years old she had a very bad burn. Dont know which degree but the upper layer was completely removed. After many months her skin grew perfectly back but between the old and new skin there is still a margin visible.
The problem with polarity TE is that nobody knows how the results are. Always very vague statements. Some of you talk about microscopic visible margin. This would be great, even if it is slightly visible.
They have something really strong. Otherwise I cannot understand why they are so damn confident.
The margin in pigs was less than the width of a hair shaft. They've stated it wasn't visible to the naked eye and that the images in their presentation are magnified to show it.
No one, PolarityTE included at this point, has any idea what the final results will be in humans and how large a margin might be. They do seem confident, and I believe that they are and should be judging on the press release yesterday, but also keep in mind that as a publicly traded company they do need to think about appearances. No, this isn't me calling them charlatans but so far the results are reported as being encouraging at the very least so they should be confident.
30 minutes ago, golfpanther said:Swanson definitely mentioned an injectable during my call with him, but honestly (and I've written this before) I have no clue how that would work.SkinTE as it exists now needs 2 things: 1. a skin biopsy of healthy tissue and 2. an excised wound bed into which the paste is applied. A pure injectable paste doesn't seem to have either of those things.
Perhaps you'd still get the skin biopsy (so it's still an autologous/homologous product), but then the procedure would already be so invasive it wouldn't really be providing much of a difference.
It's key that whatever the injectable is maintains its autologous/homologous (from patient/for patient) properties. If it doesn't (i.e. they create the paste in a lab as a one product for all type thing), I don't think they could qualify for the the 361 regulatory arm of the FDA, which would likely result in needing to put the derivative through trials. Swanson also discussed an over-the-counter solution, but hinted that it would probably need a different regulatory pathway.
Perhaps they could find a way to take the cells from your body without a full skin biopsy. To clarify, I have no idea, but I do think the derivatives might take longer to iron out than we'd like.
The margin in pigs was less than the width of a hair shaft. They've stated it wasn't visible to the naked eye and that the images in their presentation are magnified to show it.
No one, PolarityTE included at this point, has any idea what the final results will be in humans and how large a margin might be. They do seem confident, and I believe that they are and should be judging on the press release yesterday, but also keep in mind that as a publicly traded company they do need to think about appearances. No, this isn't me calling them charlatans but so far the results are reported as being encouraging at the very least so they should be confident.
I think the key for the injectable version of skinTE is their words " skinTE not only regenerates full thickness organizes skin with wound beds but will also propagates into old scar tissue and regenerate full thickness skin'' it isn't clear but I understand from their words that skinTE expands into a scar and regenerates the skin.......
18 minutes ago, damnBOY said:54 minutes ago, golfpanther said:Swanson definitely mentioned an injectable during my call with him, but honestly (and I've written this before) I have no clue how that would work.SkinTE as it exists now needs 2 things: 1. a skin biopsy of healthy tissue and 2. an excised wound bed into which the paste is applied. A pure injectable paste doesn't seem to have either of those things.
Perhaps you'd still get the skin biopsy (so it's still an autologous/homologous product), but then the procedure would already be so invasive it wouldn't really be providing much of a difference.
It's key that whatever the injectable is maintains its autologous/homologous (from patient/for patient) properties. If it doesn't (i.e. they create the paste in a lab as a one product for all type thing), I don't think they could qualify for the the 361 regulatory arm of the FDA, which would likely result in needing to put the derivative through trials. Swanson also discussed an over-the-counter solution, but hinted that it would probably need a different regulatory pathway.
Perhaps they could find a way to take the cells from your body without a full skin biopsy. To clarify, I have no idea, but I do think the derivatives might take longer to iron out than we'd like.
The margin in pigs was less than the width of a hair shaft. They've stated it wasn't visible to the naked eye and that the images in their presentation are magnified to show it.
No one, PolarityTE included at this point, has any idea what the final results will be in humans and how large a margin might be. They do seem confident, and I believe that they are and should be judging on the press release yesterday, but also keep in mind that as a publicly traded company they do need to think about appearances. No, this isn't me calling them charlatans but so far the results are reported as being encouraging at the very least so they should be confident.
I think the key for the injectable version of skinTE is their words " skinTE not only regenerates full thickness organizes skin with wound beds but will also propagates into old scar tissue and regenerate full thickness skin'' it isn't clear but I understand from their words that skinTE expands into a scar and regenerates the skin.......
this is what we should ask them what they mean with their words.
I know that the SkinTE product propagated into existing scar tissue. However, my point is that SkinTE works by taking a skin biopsy, processing it into a paste and then excising an existing wound it can be applied to. All of those components are critical to its function.
A standalone injectable (to be a derivative for the cosmetic market and fulfill a different niche) would have to offer something less invasive to be successful. The reason SkinTE is on the market now is because of the autologous/homologous design (something they rightfully drill into people's minds). A derivative injectable would only be appealing if it didn't require a skin biopsy... but I don't see how you make the product, and maintain the autologous/homologous component, without it.
In theory, I guess they could create an injectable loaded with HAD5 with the hope that it would cause the body to produce LGR5 and LGR6 cells that would flood the existing scar and transform it into regenerated, healthy skin. But that would no longer be from patient/for patient so I would think (and I could be wrong) that any product like that would have to go through trials to prove its safety.
All just speculation on my part, I should have asked more about this on my call with Swanson but I had limited time and I'm not sure they were even able to talk about this stuff yet.
Edit: I should note that when I wrote "successful" in regards to a possible injectable, I meant commercially. If it still needs a biopsy it wouldn't tap into a big enough secondary market to be worth it in my opinion.