Acne.org Products
He also said that with the 501k process, he thinks the hydrogel could get FDA approval in as little as 3 months. He said they just need one more preclinical test (with pigs - which in his 10 year experience he says regenerate better than mice). He also said that he is confident that it will work on humans if there is funding...
Brilliant.
He also said that with the 501k process, he thinks the hydrogel could get FDA approval in as little as 3 months. He said they just need one more preclinical test (with pigs - which in his 10 year experience he says regenerate better than mice). He also said that he is confident that it will work on humans if there is funding...
3 short months from any given moment and our lives could be restored - and millions of others around the world - it's so close, yet it still seems so far away. This has to get funding. Like, right now. I'm going crazy here. 
There's been like 10 emails back and forth with each of them.
Over the past couple months I've pretty much posted everything said word for word in various posts.
He also said that with the 501k process, he thinks the hydrogel could get FDA approval in as little as 3 months. He said they just need one more preclinical test (with pigs - which in his 10 year experience he says regenerate better than mice). He also said that he is confident that it will work on humans if there is funding...
3 short months from any given moment and our lives could be restored - and millions of others around the world - it's so close, yet it still seems so far away. This has to get funding. Like, right now. I'm going crazy here.
3months is new information to me, and like you personally, this now feels so close, yet so far away. And with that I hate the fact this has waited 8month already for funding. 8 months... Also, logic shows all scaffolds do is get digested by the white blood cells from the mammal. When they are digested cells are created. I expect at the least, equal results in all mammals (going on how scaffolds behave similar in all mammals), and with the fact all mammals have whiteblood cells and neutrophils, and bgger mammals in general create more whiteblood cells and neutrophils; so with him saying regeneration works better on pigs than mice there is nothing out of the ordinary here.
(note, all mammals have whiteblood cells and neutrophils responses that digest the hydrogel, with bigger mammals having a bigger whiteblood cell neutrophil response, so to me logically, this does not suprise me he observes that a pig digests/regnerates better)
There's been like 10 emails back and forth with each of them.
Over the past couple months I've pretty much posted everything said word for word in various posts.
Well it would be nice if you could post us at least the last e-mail answers from dr Sun and dr Harmon so we can read it, here we can read only your interpretations, maybe we have different interpretations on their answers!? And if I was the one who got the answers from them I would share it with everyone here and let everyone interpret their answers on their way. And that for 3 months for FDA approval sounds weird, it is known that the approval process for other hydrogels (Halscion, InVivo Therapeutics, Oculus,...) will last much longer than 3 months. 
I don't understand it.
And that for 3 months for FDA approval sounds weird, it is known that the approval process for other hydrogels (Halscion, InVivo Therapeutics, Oculus,...) will last much longer than 3 months.
I'm not certain. Sun just said that's how long he thought it would take. He could be wrong. His justification was by means of the 501k process for medical devices. I don't know much about it, but what I've read recently, it does in fact seem like approval can be achieved very quickly.
I also don't know anything about these other hydrogels that you mentioned - but could it be that they are being used for purposes aside from wound healing? - New purposes that hydrogels haven't been used for yet? - I know that one of the things that enables a device to move so quickly through the 501k is when there is already a device/devices that are like it that have been FDA cleared - ie. hydrogels for wound healing. Which there are certainly plenty of those. Just a thought, but that could be it.
And that for 3 months for FDA approval sounds weird, it is known that the approval process for other hydrogels (Halscion, InVivo Therapeutics, Oculus,...) will last much longer than 3 months.
I'm not certain. Sun just said that's how long he thought it would take. He could be wrong. His justification was by means of the 501k process for medical devices. I don't know much about it, but what I've read recently, it does in fact seem like approval can be achieved very quickly.
I also don't know anything about these other hydrogels that you mentioned - but could it be that they are being used for purposes aside from wound healing? - New purposes that hydrogels haven't been used for yet? - I know that one of the things that enables a device to move so quickly through the 501k is when there is already a device/devices that are like it that have been FDA cleared - ie. hydrogels for wound healing. Which there are certainly plenty of those. Just a thought, but that could be it.
Perhaps Sun meant 3months for approval after the testing.
And that for 3 months for FDA approval sounds weird, it is known that the approval process for other hydrogels (Halscion, InVivo Therapeutics, Oculus,...) will last much longer than 3 months.
I'm not certain. Sun just said that's how long he thought it would take. He could be wrong. His justification was by means of the 501k process for medical devices. I don't know much about it, but what I've read recently, it does in fact seem like approval can be achieved very quickly.
I also don't know anything about these other hydrogels that you mentioned - but could it be that they are being used for purposes aside from wound healing? - New purposes that hydrogels haven't been used for yet? - I know that one of the things that enables a device to move so quickly through the 501k is when there is already a device/devices that are like it that have been FDA cleared - ie. hydrogels for wound healing. Which there are certainly plenty of those. Just a thought, but that could be it.
Perhaps Sun meant 3months for approval after the testing.
Yes, that's definitely what he meant. But even still - how long could testing take? - Probably like a month or two, right? I mean, it's pretty easy to test one pig and see if it works. Then we'll say they could get the final report of the test written up and official within say another month. So, we're talking 5-6 months from the time it's funded? Unless I'm missing something, but even that seems like an overshoot if they were really pushing for it to get out there.
@vladislav, I would love to read the e-mails as well but I'm guessing some of them might come with a disclaimer that the contents of the e-mail are the recipient's eyes only. So posting it to a message board like this would break that confidentiality. If not, then it would be cool if chuckstonstew posted some of their responses here.
3 months (whether it's after testing for approval or something else) sounds fantastic. Looking forward to hearing Dr. Harmon's thoughts after Labor Day!
And that for 3 months for FDA approval sounds weird, it is known that the approval process for other hydrogels (Halscion, InVivo Therapeutics, Oculus,...) will last much longer than 3 months.
I'm not certain. Sun just said that's how long he thought it would take. He could be wrong. His justification was by means of the 501k process for medical devices. I don't know much about it, but what I've read recently, it does in fact seem like approval can be achieved very quickly.
I also don't know anything about these other hydrogels that you mentioned - but could it be that they are being used for purposes aside from wound healing? - New purposes that hydrogels haven't been used for yet? - I know that one of the things that enables a device to move so quickly through the 501k is when there is already a device/devices that are like it that have been FDA cleared - ie. hydrogels for wound healing. Which there are certainly plenty of those. Just a thought, but that could be it.
Perhaps Sun meant 3months for approval after the testing.
Yes, that's definitely what he meant. But even still - how long could testing take? - Probably like a month or two, right? I mean, it's pretty easy to test one pig and see if it works. Then we'll say they could get the final report of the test written up and official within say another month. So, we're talking 5-6 months from the time it's funded? Unless I'm missing something, but even that seems like an overshoot if they were really pushing for it to get out there.
Hopefully the new legislation will speed things up on this too.
Hey Seabs and others can you explain me what is the difference between dextran hydrogel and Acell ECM? Both are in fact the ECMs, aren't they? I don't know whether their ECM can regenerate hair follicles and sebaceous glands or not? And is it scarless healing or scar free healing? I don't know too much about Acell... I know they have the ECM that is made from big bladders and I know they were able to regenerate human fingertip... is that company success or failure? Are they now conductiong some clinical trials or not?
@Vlad an extracellular matrix is a 'biomaterial' that comes from a mammal body. They are used and utilized in many body tissues. http://en.wikipedia....ECM_Biomaterial They slowly degrade in the body, some can be rejected by the body if denatured enough. You can see many results of many sterilized for human use biomaterials on the net. IMO in the main, the only results I've seen in skin with any sterilized ECM are scarless healing (white tissue, is noticable, but the tissue is soft apparently). I get the impression they would be of value for structures were you'd need a slower digestion.
Ok, but what is the essential difference between the ECM and the hydrogel in the process of tissue regeneration? Can Acell ECM accelerate re-epithelialization, regenerate vascular networks, hair follicles and sebaceous glands or not? And what do you thnik whether dextran hydrogel should have superior results compared to the Acell's ECMs? And what happened with Acell - are there any clinical trial photos (ECM vs placebo scar) and was it failure/scam like Renovo or what?
@Vlad I dont compare. imo both have uses, e.g. With regards to ecms what ever brand, logistically I'd want an ECM in my esophagus, if I had to have it taken out, as I'd imagine a tougher slower degrading ecm would work better in that acidic environment maybe. But with regards to only ECMs of what ever brand, They degrade slowly over months. In the main I've never seen a sterilized for human use ECM get scar free healing in the skin. if you look around the net you will see many results, decide for yourself.
But one thing I will say is any hydrogel will work equally on all mammals if treated equally, if you look at all scaffolds they behave equally in what ever mammal, a scaffold does not have mammal racism if you like (discrimination). It is impossible, It does not say, I dont like these two legged mammals with wings then harm them. All scaffolds do is get degraded at various speeds, by the neutrophils. When degraded cells are created and the body does the rest. BTW In the paper the dextran hydrogel had way more nevasculization than the standard control, it got complete regeneration in the skin from a third degree burn.
Fibronectin could be used as a scaffold for wound healing with minimal scarring:
http://www.technolog...ng-wounds-heal/
Growing Organs and Helping Wounds Heal
Using natural proteins rather than synthetic polymers or decellularized organs reduces the likelihood that the new tissue will be rejected once it's implanted.
Other than building three-dimensional scaffolds for organ reconstruction, the new fabric could be embedded in bandages, accelerating wound healing and minimizing scar formation.
But those guys from the UoK and UoF said that salamanders have lower level of fibronectin than mammals during wound healing, I don't understand it.
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0032875?imageURI=info:doi/10.1371/journal.pone.0032875.g011
Analysis of newly forming dermal ECM suggests that low levels of fibronectin and high levels of tenascin-C promote regeneration in lieu of scarring.
Alright all. I spoke to Harmon. Here's the deal.
He said currently they are waiting for a reply from the US Army about funds. He said they should hear back from them by November. If they get the funds, obviously they'll be able to move forward. If not - He said we will further discuss ways we can get involved and ways we could help with the funding.
However, here's the other part that I'm sure some of you will frown upon. With this project for the Army, they are not focusing on the original 80/20. They are focusing on the new gel that they have developed that I mentioned several posts back. The one that self adheres and includes antibiotics. He claims that it would be a smoother path to clinic.
He did say this though, and I quote, "But we have not forgotten about the 80/20 gel. The new gel is very similar to the 80/20. We will only go with it if it proves to be as good or better than the 80/20." - Which is good news.
Unfortunately, if it's not as good or better than the 80/20, that's just more time we all have to wait for progress- and more funding that they would have to attempt to gather/wait for. And I don't see how something could be smoother clinically than something as simple as the original 80/20 composed of just water and dextran. Oh well though. That is where we currently stand.
Alright all. I spoke to Harmon. Here's the deal.
He said currently they are waiting for a reply from the US Army about funds. He said they should hear back from them by November. If they get the funds, obviously they'll be able to move forward. If not - He said we will further discuss ways we can get involved and ways we could help with the funding.
However, here's the other part that I'm sure some of you will frown upon. With this project for the Army, they are not focusing on the original 80/20. They are focusing on the new gel that they have developed that I mentioned several posts back. The one that self adheres and includes antibiotics. He claims that it would be a smoother path to clinic.
He did say this though, and I quote, "But we have not forgotten about the 80/20 gel. The new gel is very similar to the 80/20. We will only go with it if it proves to be as good or better than the 80/20." - Which is good news.
Unfortunately, if it's not as good or better than the 80/20, that's just more time we all have to wait for progress- and more funding that they would have to attempt to gather/wait for. And I don't see how something could be smoother clinically than something as simple as the original 80/20 composed of just water and dextran. Oh well though. That is where we currently stand.
@Chuckstonchew cheers for the update.
This (the 8020) could be approved in say 6month if it got funding. To me this wait feels unjust.
Also, imo, I dont see any reasoning for adding antibiotics to the gel. Here is my logic using facts we currently have:
The dextran 8020 had 100% survival, one of the the controls, the one with just the dressing got 60%, Facts. So were does someone come up with it needs antibiotics added?
Another bit of thinking I have, which I believe fits in an established logical framework (revolving the neutrophils rapid digestion of the 8020). Why would you add something? Would this would make the neutrophils work harder? (e.g. if you ate a plain hamburger your body could digest it more efficiently than it would with a hamburger with a salad) IMO though someone could give reason to the adhesive being added for really big 'emergency' burns, a stick would be important. However for non life emergency threatening opened wounds I reckon, you would be better off using just the 8020.
Alright all. I spoke to Harmon. Here's the deal.
He said currently they are waiting for a reply from the US Army about funds. He said they should hear back from them by November. If they get the funds, obviously they'll be able to move forward. If not - He said we will further discuss ways we can get involved and ways we could help with the funding.
However, here's the other part that I'm sure some of you will frown upon. With this project for the Army, they are not focusing on the original 80/20. They are focusing on the new gel that they have developed that I mentioned several posts back. The one that self adheres and includes antibiotics. He claims that it would be a smoother path to clinic.
He did say this though, and I quote, "But we have not forgotten about the 80/20 gel. The new gel is very similar to the 80/20. We will only go with it if it proves to be as good or better than the 80/20." - Which is good news.
Unfortunately, if it's not as good or better than the 80/20, that's just more time we all have to wait for progress- and more funding that they would have to attempt to gather/wait for. And I don't see how something could be smoother clinically than something as simple as the original 80/20 composed of just water and dextran. Oh well though. That is where we currently stand.
If it's a smoother ride to the clinic and it's as good as the hydro/dextran one then there's something to be said for their choice, in my opinion. Thanks for sharing, chuckstonchew.
Thanks @chuckstonchew! 
Novembers not too long to wait!!!
And I can't believe the army wouldn't be interested in this - I know that's presumutious of me, I have absolutely no knowledge of who runs the army - never mind who decides on it's medical research funding - but who wouldn't be interested in this!! especially the army, and I can't imagine that the experiments would cost that much relative to other experiments ithey've done - and there is so much to gain!!
Personally I'm not worried either at all about them trying to make a gel thats like the 8020 but with extras - as I understand it they want it to be 'sticky' and to have antibiotic qualities - both of which make sense - as the tests on the mouse were done on it's back - a quite flat surface - but obviously lots of the human body is rounded and not flat at all - imagine if a hand was burnt - or a face - or most of a body - the gel would have to be sticky or it just couldn't be held in place with bandages
also - the antibiotocs makes sense - the mice are probably in a nice clean lab - and I imagine it's quite easy to pick up bacterial infections in hospital or anywhere if the outer layer of your skin is ripped off - as that's part of why it's was there in the first place - as a barrier to bacteria in the outer world - so they're just trying to make their product as useful as possible - to make sure it's got no fatal flaws
I now keep imaging what else this could do if it passes experiments and gets to use in the real world - if wrinkled skin was removed and regenerated would it be without the wrinkles built up from years of facial expressions and sun exposure? or would it look just the same? What about the skin and hair on a balding man - would the hair be full again? Sorry -it's a bit off tpoic - just my mind wandering! If it cured anyone from ever being scared again that would be plenty!!
