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Pretty sure they mentioned "we expected it to be out in a year or two" because its a class 2 device or something
They -suddenly- interrupted the process with the acute wound trial. Had they kept on track, they could have met the timeframe quoted last summer. It's a bummer, but we can't blame them for trying to trying to break free from those "niche markets" that were quoted earlier this year.
To be honest, even I am surprised despite keeping up with them. I expected them to maintain the trials limited to controllable protocols (i.e. Let the wound close, drastically reduce the probability of infection, then remove the tissue and use the scaffold). Depending on the protocol of the new trial, they may be trying to directly apply the HG into the original wound (after removing debris, etc.) a la bacta gel. Completely unexpected.
Out of curiosity, what ever happened to Acell's Matristem? I've looked into it, but cannot find anything verifiable about it related to the prevention of scarring. It seems to kind of fallen out of focus, and I'm curious as to why this is. I would be interested to see if, considering that atrophic scars simply result from a loss of collagen, theoretically, injections of Matristem into the depression would repair collagen damage. If all goes well, you wouldn't even have to excise the scar. This is the promising part about atrophic scars not actually being scar tissue. You could theoretically promote growth, regrowth, and regeneration from within without damaging the skin, because there is no over expression of scar tissue preventing proper regeneration, which is the case in hypertrophic and other forms of scarring.
I'm not completely positive at this point, but I believe that atrophic scars resist healing and persist due to damage of the extracellular matrix within the skin. If you injected a foreign ECM into the depression, such as Matristem or DHG, then it should solve the issue.
Someone correct me if I'm wrong.
@bozo, as far as i know:
1. If acne scars destroy fat and cant regenerate it is right.. yet dextran hydrogel regenerate 3rd degreee burn which is far deeper in skin than acne scars
2. Even if it ddestroy ECM, dextran hydrogel serve its function as ECM, i've read this before...
Hope my answer helps
If animal trials starts from 2011 and end in 2015, human trials start from 2016 late or maybe even 2017 and end up in 2021 plus a year if there is any procastrination and market availability
We will get it at 2022 if everything goes smoothly i think
You are aware that the first porcine test was basically a repetition of the murine trial on a different model and that they basically spent all of 2012 and most of 2013 inactive... Right?
If animal trials starts from 2011 and end in 2015, human trials start from 2016 late or maybe even 2017 and end up in 2021 plus a year if there is any procastrination and market availability
We will get it at 2022 if everything goes smoothly i think
You are aware that the first porcine test was basically a repetition of the murine trial on a different model and that they basically spent all of 2012 and half of 2013 inactive... Right?
Well, no im not...
I just thought it was this order :
1. Mice
2. Porcine
3. Human
Simply without repetition of the first subjects
Interesting news and thanks for posting the website, thecureforscars.
I think it's important for us to remember that while we all want the dextran hydrogel to work and be on the market ASAP, Gerecht's lab is also doing other research that likely divides her time and their resources. This year alone they have 14 published articles, some connected to the work going on with the hydrogel and some not (they're involved heavily in cancer research as well).
Also, on the subject of a timeline, going off their original quoted timeframe for approval after starting human trials (if the FDA considers the hydrogel a device) of 18-24 months that would put us somewhere in the neighborhood of 2018-2019 for when the hydrogel hits the market (if human trials start in mid-late 2016 as written on the website). It's not ideal, but quicker than many people were speculating about on the board.
Obviously, this is all just an estimate based on present information, which could change drastically. I hope they have a paper upcoming for what results they've gathered so far, but in my previous conversations with Dr. Sun he said that was unlikely (although, he works at Columbia now and at the time of the email so he could be wrong).
JT1986, have you been in direct contact with them recently?
Golfpanther and everyone, i may have an opinion to reply Bozo as stated in my second last post, but bozo there stated that atrophic scars are different than hyperthropic and keloid scars...
We all should reconsider about this.. even if hydrogel works, our acne atrophic scar may not get the same result im afraid
What do you guys think?
you should stop looking for a cureforscars then
Pretty sure they mentioned "we expected it to be out in a year or two" because its a class 2 device or something
They -suddenly- interrupted the process with the acute wound trial. Had they kept on track, they could have met the timeframe quoted last summer. It's a bummer, but we can't blame them for trying to trying to break free from those "niche markets" that were quoted earlier this year.
To be honest, even I am surprised despite keeping up with them. I expected them to maintain the trials limited to controllable protocols (i.e. Let the wound close, drastically reduce the probability of infection, then remove the tissue and use the scaffold). Depending on the protocol of the new trial, they may be trying to directly apply the HG into the original wound (after removing debris, etc.) a la bacta gel. Completely unexpected.
this is very sad news, guess i was wrong to bet on hydrogels...
This whole HG should be approved for market in 2016 to 2017, 2 to 3 years after the animal testing began in 2014. The 2 to 3 years just like has been stated a few times. As this is a class II device, all this needs is clearance from the FDA, I've read somewhere the FDA has roughly 90 days to give clearance in 510's after filing; but this should be less with this one as I'm sure this will be 510 exempt saying the ingredients in the HG are known to be safe. You only need 'one' human test protocol (say 3month) and to show the historic data, which shows safety and effectiveness. Upon clearance they will be allowed to sell the product immediately. As the HG will already be available in the vet market; I'm guessing the manufacturing jets will also be fired up upon clearance, imo, this should allow for immediate production.
Golfpanther and everyone, i may have an opinion to reply Bozo as stated in my second last post, but bozo there stated that atrophic scars are different than hyperthropic and keloid scars...
We all should reconsider about this.. even if hydrogel works, our acne atrophic scar may not get the same result im afraid
What do you guys think?
Don't misunderstand me, I certainly believe that DHG will be effective in the treatment of atrophic scarring. However, the most effective method of treatment can only be speculated at this point. Theoretically, DHG should be able to be injected into the depression of an atrophic scar, thus treating the scar from within. This is because, as someone mentioned before, DHG is thought to primarily treat wounds and scars via acting as a synthetic ECM. Atrophic scarring, particularly acne scarring, results from damage to the native ECM, causing collagen damage from the inside. Contrary to what many people believe, an acne scar is not damage to the external layers of the skin, but rather to the internal layers of the skin. If the damage is on the inside, then the treatment should be effective on the inside. I theorize that this is why external treatments display modest, if any effectiveness. External treatments do not penetrate into the deep layers of the skin.
And let me clarify, the fundamental difference between a hypertrophic scar and an atrophic scar is that hypertrophic scars are the result of an over expression of collagen in response to injury, while atrophic scars are the result of an under expression of collagen due to internal damage of the ECM, and incomplete healing. This is the pathology of scars as I understand it through research. It is for this reason that treatments based on resveratrol and decorin may not be beneficial in the treatment of atrophic scarring, as they work primarily by breaking down excess collagen. However, synthetic and foreign ECM's such as DHG and Matristem would theoretically be effective in the treatment of atrophic scars by providing a scaffold for cells, promoting the regeneration of collagen. DHG and Matristem would not, however, be effective in the treatment of chronic hypertrophic scarring, as the excess collagen associated with hypertrophic scarring prevents cells from penetrating into the wound site and repairing the tissue properly. If you were to treat a hypertrophic scar with a foreign ECM, you would have to excise or otherwise dissolve the scar tissue, and then apply the scaffold to promote scar free healing of the induced wound.
What you need to understand about the hydrogel is this:
Five weeks. 35 days.
That is all it took from application to fully restored skin in the original mice study.
Meaning when human trials start in second half of 2016 (somewhere between 1 year and 7 months and 2 years and 1 months from now) it will only be 5 weeks after that, that they see the results and can hopefully confirm that it works 100%. After that moment my guess is that it will be a very quick rush to approval and market. Hydrogels are safe, dextran is safe. There can be very little safety worries.
Golfpanther and everyone, i may have an opinion to reply Bozo as stated in my second last post, but bozo there stated that atrophic scars are different than hyperthropic and keloid scars...
We all should reconsider about this.. even if hydrogel works, our acne atrophic scar may not get the same result im afraid
What do you guys think?
It's something to think about but immaterial to how the dextran hydrogel would function and be used (at least based on the trials with mice, which we're all familiar with).
The only way the dextran hydrogel works is to create a wound bed through excision or dissolving the scar tissue. At that point, the type of scar that it was (since it has now been removed from the body) is irrelevant. The dextran hydrogel would then be placed on the new wound bed that had been created and allowed to do its work.
Hopefully, it would then interfere with the normal scarring pathway for human healing and lead to a path of regeneration. It's not used as an injectable into already existing scars; it needs a wound bed to function properly. Just look at the original research paper; the investigators didn't scar the mouse, wait for scar tissue to form and then inject the hydrogel into the scar. They burned the mouse, removed the damaged tissue and then place the dextran hydrogel over the wound bed. We can assume the same methodology would be applied to humans if its found to be effective in our species.
someone should just get more efficient employees lol. how many tests do you need to do on animals that takes 2 freaking years?
its very stupid of them to delay the market time , a cure for scars would be big and all the money from lasers would go to them the faster they release.
I bet thats why they wont relase it because why make something that fixes scars for cheap when people will be crazy money to fix them anyway with what ever improvements they get
The company that is developing the hydrogel has no reason to care that other companies that are selling ineffective scar treatments will see their sales suffer. That's just competition.
Just trying to catch up, what technology or product are all of you guys referring to? That 'needs to be released'
Dextran Hydrogel, intended for complete skin regeneration and prevention of scarring, and developed in research at John Hopkins, now undergoing clinical trials in animals with human trials to start in 2016. A company has formed to bring it forward, called Gemstone Biotherapeutics.