Acne.org Products
Where is @golfpantherwhen you need him
If the regenerated skin will be like the donor skin... well, then SkinTE wont be usefulat all, would it?! I thought we asked Polarity about this???!
If this is the case it will be a major let down and I cant see how this can be used for cosmetics. Even in the face the skin is different regarding thickness, hair etc.
18 minutes ago, Frasier said:If the regenerated skin will be like the donor skin... well, then SkinTE wont be usefulat all, would it?! I thought we asked Polarity about this???!
If this is the case it will be a major let down and I cant see how this can be used for cosmetics. Even in the face the skin is different regarding thickness, hair etc.
PolarityTE fails.. end of story
20 minutes ago, rudy1986 said:39 minutes ago, Frasier said:If the regenerated skin will be like the donor skin... well, then SkinTE wont be usefulat all, would it?! I thought we asked Polarity about this???!
If this is the case it will be a major let down and I cant see how this can be used for cosmetics. Even in the face the skin is different regarding thickness, hair etc.
PolarityTE fails.. end of story
Let me point out that I do believe that the regenerated skin will take the properties of the surrounding skin. I still have faith in SkinTE.
There was talk about taking a biopsy from the armpit or somewhere comparably unnoticeable to grow skin for facial scars. This would be ridiculous if the regrown skin took on the properties of the biopsy, and not the area it is applied to. You would have thin and wrinkly armpit skin for your facial skin. And I don't think it's consistent to assume that it would just be properties like the density and size of hair follicles that the regenerated skin takes on from the biopsy. It would be more consistent to assume that the regenerated skin would take on the properties of the biopsy not only of hair follicles, but also of every other property, such as thickness, texture, elasticity and so on. Perhaps this wouldn't be the way SkinTE turns out to work, if at all. But if it were, then I don't think it can be used for aesthetic purposes as it is. For example, it wouldn't be able to produce the subtle differences in thickness of unscarred skin that is necessary for facial shape.
Yeah, I was under the same impression. Butguy on hair loss forum talked with Swanson, and apparently it does take donor site properties.. Personally, I think SkinTE is just a more efficient version of full thickness skin graft. The donor skin is applied on the wound and it grows/expands in that environment not letting the wound scar..
I wouldnt mind having different skin texture on the cheeks than original. Sure, it would look different, but it could look good. Some of the full thickness face skin graft photos already look very impressive.. The reasons that they are not used for acne scars are different texture, color and donor site scarring. So with current grafts, skin on the face usually comes from another body part as face is a not a best donor site.. With SkinTE, graft could come from the face and could cover large area including the donor site. And it could have more similar texture to the rest of the face. I am sure a good surgeon could blend the margins with beard or jaw line and so on. It would look different than original skin maybe, but would still be good I think.
All of this is speculation of course, but there isnt anything else to do lol.
10 minutes ago, Anonymouz1 said:I believe SkinTE is what I thought it would be. The skin biopsy that will be taken will depend on which part of the body it is taken from. Normally, a wound will contract as it is healing. I believe, applying this SkinTE paste will stop the skin from contracting and the paste will expand outward thus covering the wound. The idea behind this is normal looking skin. Now it would make sense as to why a margin would exist. The people behind Polarity, already mentioned about the margin. The paste applied on the wound will be compacted skin grown from the biopsy and with the help of LGR5 genes it will expand. Obviously, this will not be rejected by the body. The biopsy will just be grown in a lab using different techniques so if it taken from a leg and applied on a face wound, the healed facial wound would look like skin on a leg.I have read the technology relies on LGR5 genes. LGR5 genes are crucial to embryonic development and are well known markers in stem cells. LGR5 markers are alsocrucial in wound repair because they tell stem cells present in the skin to become fibroblasts to close the wound. It seems, LGR5 genes are responsible in telling cells what they should divide into.
If the wound is small, you have complete regeneration. This is why small scrapes and cuts don't scar. If the wound is large, the LGR5 genes cannot get the message across for regeneration and thus scar tissue is formed.
I guess it is a trade off. Get a scar in a easily hidden place and erase the scar in a visible area. For burn wounds, It is better to have somewhat normal looking skin than skin grafts or skin substitutes that scar anyway. Burn scars are also hard, thick and inflexible. It would be a better alternative to what exists presently for burn victims provided it will work.
As for FDA approval, I searched for Polarity or SkinTE on the FDA website and couldn't find anything with those search terms. This is in contradiction to what Polarity co-founders are telling us. Although going through stock investor information online, websites seem to indicate the company is FDA approved. I am quite skeptical on this as well.
As far as the FDA goes, there is a difference between the term "approval" and "registered." This gets back to how SkinTE is regulated as a product by the FDA.
As I stated earlier, SkinTE is regulated under the HCP/T 361 arm of the FDA. Per my convo with Swanson there are basically four criteria that need to be met in order for a product to meet this criteria (refer to my earlier post if you're inclined). The big one for them is homologous/autologousfrom patient, for patient. It basically means that the process is using the patient's own tissues (the skin biopsy) to create the product and returning it back to them (the paste).
They are registered with the FDA for commercial use. This means they can sell their product but don't have approval. The use of approval in this case means the FDA has looked at data on patients and given it their sign-off as being a product that offers an improvement in treating whatever the indication isin this case wound healing. SkinTE, as a registered product under the 361 regulatory arm, will undergo post-market evaluation by the FDA and could receive approval at a later time. SkinTE simply can't be approved yet because there is no data on patients for the FDA to approve.
Swanson went into the details as to why they chose the 361 pathway. For one, other products that go through extensive clinical trials only get approval for one indicationi.e. it may be approved for burns, but not surgical scars. This made little sense for their ambitions (complete regeneration across a wide variety of skin defects) and if it works we should be thrilled they chose this way of doing things. Otherwise, doctors wouldn't be able to use the products outside the scope of FDA approved wound types without facing liability issues.
I can sense possible questions about why every regenerative medicine company doesn't do the 361 approach. The simple answer is, they can't because most products do not qualify all four requirements to go that route. They either add something, focus on changing one cell type into another or use cells from another animal or dead body. Those things all automatically disqualify you from the 361 route and you have to go through clinical trials for safety as much as efficacy.
52 minutes ago, SimpleMutton said:I don't know about forums for burn victims unfortunatelyAnyway I was looking at PolarityTE stock price, in the afterhours is increasing a lot...it's beyond 25$ per share, it closed at 24,06 after having been good in the last couple of days....who know, maybe some insiders have had good news about first results on human patients....
The stock has been hovering around between $22-$24 for about a month now so I don't think that's enough volatility to signal much. If after next Tuesday (the last day of that conference) it shoots up to over $30 or the like, then I think you can start to think SkinTE is at least offering significant improvement over existing treatments.
Some insight into the potential costthis is Ned Swanson speaking on a conference call PolarityTE did right after releasing the preclinical data:
"I think when you start to look at the economics of SkinTE and the cost of goods, we are able to do this quite cheaply. And part of that is based upon our processing of the tissue at the manufacturing center when we start to begin to do this clinically. The tissue itself has to be harvested from the patient, which is going to be done in a very streamlined manner. The physician is going to have a complete harvest box with all components in it, to harvest for full thickness skin biopsy. You can do this at the bedside in the ER or in the OR.
The tissue will come to the manufacturing facility. It will be processed and turned around within one to two days back to the center, as Denver described previously. And with all of those components said, the way we process this avoids a lot of the costs seen with products like Epicel that Denver mentioned, where we aren't culturing this for three to four weeks. We don't need enzymes to do this. We don't need media to do this. Those are all the factors that make a lot of regenerative medicine products extremely, extremely expensive in the thousands of dollars range to produce based on all of those components required.
So, needless to say, we can do this quite cheaply and quite efficiently for each one of these products produced. And the market Denver described is based on a lot of market research that weve done before we became involved in this. We have done our own market analysis on all of these specific arenas.
We have done the most analysis in the burn market, and the ability of us to deliver those products so cheaply allows us to essentially provide a much greater value with the product we're delivering, while at the same time potentially coming in at a lower cost, which throughout all industries is a large leap in technology to be able to do that. So, I don't want to get into all of these specific numbers, but they're favorable on both ends for the way we create the SkinTE."
For reference, the one company heexplicitly mentions, Epicell, is said to be $6,000-$10,000 for 1% total body surface area (via a quick google search). Considering what Swanson states above regarding a processing time of hours and returned to patient in 1-2 days it's likely to be far cheaper. However, keep in mind that if they get complete regeneration in humans they aren't going to be really competing with anyone anymore. They could charge whatever they wanted for a time before, as others stated, companies scrambled to mimic their results and come in at lower costs. Now, I'm not sayingthey willdo this, but it's a possibility.
2 hours ago, eekman said:Yeah, I was under the same impression. Butguy on hair loss forum talked with Swanson, and apparently it does take donor site properties.. Personally, I think SkinTE is just a more efficient version of full thickness skin graft. The donor skin is applied on the wound and it grows/expands in that environment not letting the wound scar..
I wouldnt mind having different skin texture on the cheeks than original. Sure, it would look different, but it could look good. Some of the full thickness face skin graft photos already look very impressive.. The reasons that they are not used for acne scars are different texture, color and donor site scarring. So with current grafts, skin on the face usually comes from another body part as face is a not a best donor site.. With SkinTE, graft could come from the face and could cover large area including the donor site. And it could have more similar texture to the rest of the face. I am sure a good surgeon could blend the margins with beard or jaw line and so on. It would look different than original skin maybe, but would still be good I think.
All of this is speculation of course, but there isnt anything else to do lol.
Do you have a link of the guy on the hair loss forum? I'd be curious to see how Swanson's answers line up with my convo with him.
Keep in mind the word properties isn't texture. Properties could mean things like sebaceous glands sweat glands, hair follicles etc. For example, you wouldn't take a skin biopsy from the bottom of my foot (one of the few places hair doesn't grow) and then slap it on my facial scar in the beard area. The hair wouldn't be there because the cells wouldn't be present to get them back.
3 minutes ago, SimpleMutton said:Thanks for the details
Just for reference:
Anterior body surface area: 4,5%
Whole Back: 18%
Whole anterior torso: 18%I need that to a big part of my back so body surface area of around 10%
No worries!
I thought I'd read or heard them say that with a 2cmx2cm biopsy they could produce enough of the product for 10% body coverage but I could have been mistaken because I can't find anything about it now. I know they've said they can process that skin biopsy into covering a much larger area of skin.
23 minutes ago, golfpanther said:Do you have a link of the guy on the hair loss forum? I'd be curious to see how Swanson's answers line up with my convo with him.Keep in mind the word properties isn't texture. Properties could mean things like sebaceous glands sweat glands, hair follicles etc. For example, you wouldn't take a skin biopsy from the bottom of my foot (one of the few places hair doesn't grow) and then slap it on my facial scar in the beard area. The hair wouldn't be there because the cells wouldn't be present to get them back.
No worries!
I thought I'd read or heard them say that with a 2cmx2cm biopsy they could produce enough of the product for 10% body coverage but I could have been mistaken because I can't find anything about it now. I know they've said they can process that skin biopsy into covering a much larger area of skin.
Golfpanther, you say that you wouldnt take a skin biopsy from the bottom of the foot to treat facial scars. But would you use skin from your armpit? Or leg? Yes, I know there are differences between the foot and armpit/leg/face, but the major question is: Does SkinTE regenerate the skinas it is supposed to beor does it imitate the skin from the biopsy? Do we have any data or quotes from Swanson/Lough that gives us information about this?
Right now I cant believe we didnt think about asking Swanson about this. Did we take it for granted?
40 minutes ago, golfpanther said:Do you have a link of the guy on the hair loss forum? I'd be curious to see how Swanson's answers line up with my convo with him.Keep in mind the word properties isn't texture. Properties could mean things like sebaceous glands sweat glands, hair follicles etc. For example, you wouldn't take a skin biopsy from the bottom of my foot (one of the few places hair doesn't grow) and then slap it on my facial scar in the beard area. The hair wouldn't be there because the cells wouldn't be present to get them back.
https://www.hairlosstalk.com/interact/threads/polarityte-update-demonstrates-the-broad-utility-of-this-novel-product-beyond-burn-care.110566/ there are quite a few threads about Polarity, but its this one. The guy used to post on this thread on our forum, but left because of negativity.. He does not provide the interview, but says that he had one. Yes, I think he only asked about hair follicles and have them in mind when talking about skin properties..
Have found some very active burn survivor groups on facebook, will ask around if anyone are treated with SkinTE when my requests are approved. Someone should know something..
1 hour ago, eekman said:https://www.hairlosstalk.com/interact/threads/polarityte-update-demonstrates-the-broad-utility-of-this-novel-product-beyond-burn-care.110566/ there are quite a few threads about Polarity, but its this one. The guy used to post on this thread on our forum, but left because of negativity.. He does not provide the interview, but says that he had one. Yes, I think he only asked about hair follicles and have them in mind when talking about skin properties..Have found some very active burn survivor groups on facebook, will ask around if anyone are treated with SkinTE when my requests are approved. Someone should know something..
Tano1 is the one you are talking about, he even posted the same interview here. Did he leave this forum btw?! I cant remember that he mentioned that the regenerated skin takes the donor site properties.
I looked up what he wrote regarding the interview with dr. Swanson:
6.)Tano1:"Regarding the skin biopsy, around how big is the skin sample that will be taken. I know it was said that it would be a small biopsy and then it's expanded using the 3D Platform Technology. So how small would the skin sample be taken, and how much can it be expanded by to sort of get an idea of the size of the wound that can be covered."
Dr. Swanson:"So you know the large majority of wounds will be addressable with that initial small sample of a few square centimeters. As you imagine there aren't many wounds that get bigger than 10% of the body, but when they do, it's not a tremendous amount more of skin that we'll require. When wounds are getting to that size, you also could have a lot of options from where the skin will come. There is no designated area where people are going to take these harvest samples."
"And we're talking very, very large wounds where sometimes for instance in burn patients, the only viable skin left is often actually the scalp or sort of protected creases like in the armpits or the groin you know, all those areas are fine for the skin to come from."
Tano1:"Oh wow that actually answers another one of my questions which was where the biopsy can be taken from if it could be taken from varying parts of the body so that's great to know."
So I really dont know what Tano1 is trying to say on the other forum.
updates from elastagen
Do not forget sunogel the guys! It will be necessary to know if with sunogel, we could benefit from properties of the surrounding skin with the skin regenerated.Dr sun sent me a message There is an unstant, By confirming me that he made a success of a scar free on the pig.I hope that he is going to find investors for the tests at the human beings
53 minutes ago, slave of jesus said:Do not forget sunogel the guys! It will be necessary to know if with sunogel, we could benefit from properties of the surrounding skin with the skin regenerated.Dr sun sent me a message There is an unstant, By confirming me that he made a success of a scar free on the pig.I hope that he is going to find investors for the tests at the human beings
Yes, Sunogel is promising. However, I talked to Dr. Sun over the phone and he's a long way away from commercial use. For one, he doesn't really sell the product when you talk to him. For another, he wants to go through a trial.
In terms of SkinTE matching the surrounding skin, I don't think anyone can say with any certainty what will happen. However, all of the studies done on human wound healing indicate that the body somehow knows what type of skin to regenerate (this is one of those fortunate things about our bodies that there is still no scientific explanation for). A while ago I posted an article that talks about this very thing.
For me, I think a skin biopsy taken from the back of your head and then processed into SkinTE for use on a face should regenerate (if it works) skin that looks like the rest of the skin on the face. I think this because it's not just the paste that's facilitating the healing, but also the cells that are propagating in the fresh wound bed. From my understanding of SkinTE the past simply prevents too many inflammatory cells (myofibroblasts) from entering the wound and instead allows for the creation of more adipocytes in the wound bed that gives us the appendages and regeneration.
I asked Swanson specifically if he believed that SkinTE would work on all parts of the body and he said yes and that the patients it's on right now had wounds across all parts of the body.
2 hours ago, Binga said:updates from elastagen
reduction 80% ????? come onnnnnnnnnnnnnnnn tropoelastin is garbage
Just now, damnBOY said:2 hours ago, Binga said:updates from elastagen
reduction 80% ????? come onnnnnnnnnnnnnnnn tropoelastin is garbage
skinte is the only way 
6 hours ago, golfpanther said:Yes, Sunogel is promising. However, I talked to Dr. Sun over the phone and he's a long way away from commercial use. For one, he doesn't really sell the product when you talk to him. For another, he wants to go through a trial.In terms of SkinTE matching the surrounding skin, I don't think anyone can say with any certainty what will happen. However, all of the studies done on human wound healing indicate that the body somehow knows what type of skin to regenerate (this is one of those fortunate things about our bodies that there is still no scientific explanation for). A while ago I posted an article that talks about this very thing.
For me, I think a skin biopsy taken from the back of your head and then processed into SkinTE for use on a face should regenerate (if it works) skin that looks like the rest of the skin on the face. I think this because it's not just the paste that's facilitating the healing, but also the cells that are propagating in the fresh wound bed. From my understanding of SkinTE the past simply prevents too many inflammatory cells (myofibroblasts) from entering the wound and instead allows for the creation of more adipocytes in the wound bed that gives us the appendages and regeneration.
I asked Swanson specifically if he believed that SkinTE would work on all parts of the body and he said yes and that the patients it's on right now had wounds across all parts of the body.
Yes, that was also what I did believe, Golfpanther. But that we dont need to make cuts in our head to do it. That SkinTe just provide the perfect scaffold to make the skin regenerate without scars.
2 hours ago, SimpleMutton said:Can you guys tell me what email address you used to contact PolarityTE?
I simply used the Contact page on their website and the Feedback option.
My message just said that I was excited about the product but that I'd read some things that concerned me and wanted to ask some questions. That was it.
On 1/6/2018 at 7:28 PM, golfpanther said:Yes, Sunogel is promising. However, I talked to Dr. Sun over the phone and he's a long way away from commercial use. For one, he doesn't really sell the product when you talk to him. For another, he wants to go through a trial.In terms of SkinTE matching the surrounding skin, I don't think anyone can say with any certainty what will happen. However, all of the studies done on human wound healing indicate that the body somehow knows what type of skin to regenerate (this is one of those fortunate things about our bodies that there is still no scientific explanation for). A while ago I posted an article that talks about this very thing.
For me, I think a skin biopsy taken from the back of your head and then processed into SkinTE for use on a face should regenerate (if it works) skin that looks like the rest of the skin on the face. I think this because it's not just the paste that's facilitating the healing, but also the cells that are propagating in the fresh wound bed. From my understanding of SkinTE the past simply prevents too many inflammatory cells (myofibroblasts) from entering the wound and instead allows for the creation of more adipocytes in the wound bed that gives us the appendages and regeneration.
I asked Swanson specifically if he believed that SkinTE would work on all parts of the body and he said yes and that the patients it's on right now had wounds across all parts of the body.
I think we all need a more definitive answer abouthow the donor site will affect the wound once it heals. If anyone can ask the SkinTe folks, that would be ideal. I keep trying but no luck. This could mean the body would heal in all sorts of whacky ways. Hairs coming out of places they're not supposed to be etc...
9 hours ago, FastMedia said:On 1/6/2018 at 6:28 PM, golfpanther said:I think we all need a more definitive answer abouthow the donor site will affect the wound once it heals. If anyone can ask the SkinTe folks, that would be ideal. I keep trying but no luck. This could mean the body would heal in all sorts of whacky ways. Hairs coming out of places they're not supposed to be etc...
In all honesty, I don't think you can get a more definitive answer at this time. It's on patients right now so once the results are published/released we'll all know, but we're all in completely uncharted territory with this. Humans have never attained complete skin regeneration following a wound so how could PolarityTE definitively answer that question before they have actual results that show SkinTE can do it?
They could say they believe the skin will taken on the properties and texture of the surrounding skin, but that would be guessing until the humans the product is on right now show them one way or another (if it provides complete regeneration).
40 minutes ago, golfpanther said:In all honesty, I don't think you can get a more definitive answer at this time. It's on patients right now so once the results are published/released we'll all know, but we're all in completely uncharted territory with this. Humans have never attained complete skin regeneration following a wound so how could PolarityTE definitively answer that question before they have actual results that show SkinTE can do it?They could say they believe the skin will taken on the properties and texture of the surrounding skin, but that would be guessing until the humans the product is on right now show them one way or another (if it provides complete regeneration).
Not true at all, especially when none of us know the specifics of who they are treating. Maybe they're only treating certain areas of the body, the question is very valid.
1 hour ago, FastMedia said:1 hour ago, golfpanther said:In all honesty, I don't think you can get a more definitive answer at this time. It's on patients right now so once the results are published/released we'll all know, but we're all in completely uncharted territory with this. Humans have never attained complete skin regeneration following a wound so how could PolarityTE definitively answer that question before they have actual results that show SkinTE can do it?They could say they believe the skin will taken on the properties and texture of the surrounding skin, but that would be guessing until the humans the product is on right now show them one way or another (if it provides complete regeneration).
Not true at all, especially when none of us know the specifics of who they are treating. Maybe they're only treating certain areas of the body, the question is very valid.
I didn't say the question wasn't valid, just that you can't get an answer at this time. There are plenty of questions in science that are valid that don't have an answer.
With SkinTE, we will have an answer very shortly. Just try to be patient everyone.