» There is no mention of safety issues, do we know the stuff is really safe
» for use in humans? Their website sucks, it’s so vague.
Their website is not updated for human use. They said that they will release it onto their website in about a month. As far as any safety concerns, it has been used on humans before, but on a very limited basis. The developer’s brother (Speivak - sp?) has used to regenerate the tip of his finger. The military is also using it on injured soldiers. I’m sure that they’ve jumped through all of the regulatory hoops to bring this to market. You can call them and ask specific questions.
My main concern is…Will it work? I have a pretty good feeling about it (and have spoken with them on several ocassions) but am afraid to get my hopes too high. They are confident that their product will regenerate donor tissue and hair but have made me no guarantees.
» » There is no mention of safety issues, do we know the stuff is really
» safe
» » for use in humans? Their website sucks, it’s so vague.
»
» Their website is not updated for human use. They said that they will
» release it onto their website in about a month. As far as any safety
» concerns, it has been used on humans before, but on a very limited basis.
» The developer’s brother (Speivak - sp?) has used to regenerate the tip of
» his finger. The military is also using it on injured soldiers. I’m sure
» that they’ve jumped through all of the regulatory hoops to bring this to
» market. You can call them and ask specific questions.
»
» My main concern is…Will it work? I have a pretty good feeling about
» it (and have spoken with them on several ocassions) but am afraid to get my
» hopes too high. They are confident that their product will regenerate
» donor tissue and hair but have made me no guarantees.
Safety does worry me a bit. The product is derived from pigs’ organs, God forbids if that carries something like the mad cow disease, the bird flu or even tumor growth, that would be disastrous.
» » » There is no mention of safety issues, do we know the stuff is really
» » safe
» » » for use in humans? Their website sucks, it’s so vague.
» »
» » Their website is not updated for human use. They said that they will
» » release it onto their website in about a month. As far as any safety
» » concerns, it has been used on humans before, but on a very limited
» basis.
» » The developer’s brother (Speivak - sp?) has used to regenerate the tip
» of
» » his finger. The military is also using it on injured soldiers. I’m
» sure
» » that they’ve jumped through all of the regulatory hoops to bring this
» to
» » market. You can call them and ask specific questions.
» »
» » My main concern is…Will it work? I have a pretty good feeling
» about
» » it (and have spoken with them on several ocassions) but am afraid to get
» my
» » hopes too high. They are confident that their product will regenerate
» » donor tissue and hair but have made me no guarantees.
»
» Safety does worry me a bit. The product is derived from pigs’ organs, God
» forbids if that carries something like the mad cow disease, the bird flu or
» even tumor growth, that would be disastrous.
I guess anything new will have some safety concerns just based on that fact that it has no history behind it to prove one way or another. The only answer to that would be to wait until you feel comfortable having the procedure done. Again, that would go for any new technological advance in medicine.
» » I wonder if Acell will work on old scar or is it more effective on fresh
» » wound.
»
» I would think that they would have to cut the old scar out and place the
» Acell material on it (thus making it a fresh wound).
Yup, I do believe this product is a winner. I’ve seen all the videos and read the articles. The US military is experimenting with it on wounded soldiers and has seen results. Just wish we can get some HT surgeons on this forum experiment with it and get back to us.
Which ever clinic that is able to produce a working protocol will have a major edge in the industry.
But seriously how can this product regenerate tissue to a degree that would allow “unlimited donor hair”. Isn’t that one of holy grails of science? To be able to create uncompromised tissue from damaged or nonexistent tissue. It almost sounds like science fiction. Surely, there would be more press, more buzz about this product, at the very least more concern.
Tissue generation is often associated with cancer. Something that induces cell growth is likely to grow out of control, that is how cells behave, and that is why cancer has been the scourge of humanity for eons. I think we have to respect the concerns that might arise from this product and be tempered in our expectations.
» But seriously how can this product regenerate tissue to a degree that would
» allow “unlimited donor hair”. Isn’t that one of holy grails of science? To
» be able to create uncompromised tissue from damaged or nonexistent tissue.
» It almost sounds like science fiction. Surely, there would be more press,
» more buzz about this product, at the very least more concern.
» Tissue generation is often associated with cancer. Something that
» induces cell growth is likely to grow out of control, that is how cells
» behave, and that is why cancer has been the scourge of humanity for eons. I
» think we have to respect the concerns that might arise from this product
» and be tempered in our expectations.
This is exciting news but I think we need to find out that this product is absolutely safe first. Shouldn’t they have the FDA trial results published somewhere by now if this has already been tested in humans and approved by thd FDA? I couldn’t find anything on their website.
isnt the FDA approval required for testing on human trials? if these have not taken place how is the product allowed to be on the market other than with vets
» is it allowed?
»
» and if so what docs would risk it?
»
» isnt the FDA approval required for testing on human trials? if these have
» not taken place how is the product allowed to be on the market other than
» with vets
It’s already being used on US soldiers (on some rather ghastly wounds).
If I could get hold of some of this, I could wound the entire scalp and apply this powder. If it grows back a full head of hair, we’re in. Otherwise, they’ll be faffing around for another 5 years before they announce it’s 5 years until human use comes to market. We have to take the initiative.
» If I could get hold of some of this, I could wound the entire scalp and
» apply this powder. If it grows back a full head of hair, we’re in.
» Otherwise, they’ll be faffing around for another 5 years before they
» announce it’s 5 years until human use comes to market. We have to take the
» initiative.
»
» I’ll try it out. Because I’m nuts.
You should be able to get some of this stuff but you will have to get through a doctor. I hope that it regrows the donor area and provides a limitless supply of donor hair for transplants. I would be shocked if it regrew and maintained hair in the bald areas of the scalp, but who knows.
»
» You should be able to get some of this stuff but you will have to get
» through a doctor. I hope that it regrows the donor area and provides a
» limitless supply of donor hair for transplants. I would be shocked if it
» regrew and maintained hair in the bald areas of the scalp, but who knows.
»
» Take Care,
» Bill
Problem is that a doctor would not risk aquiring or prescribing some because as yet, it is an unknown. And also hasn’t been through human trials.
If I could just get my mitts on some.
» is it allowed?
»
» and if so what docs would risk it?
»
» isnt the FDA approval required for testing on human trials? if these have
» not taken place how is the product allowed to be on the market other than
» with vets
From the Acell Website:
A similar “first generation” ECM technology called SIS (derived from porcine small intestine) has been used to treat over 500,000 patients with remarkable effect. ACell’s UBM is the next generation of ECM technology due to its unique characteristics featuring a basement membrane surface which is ideal for epithelial cell growth in many applications.
Five FDA 510(k) Clearances for Multiple Clinical Applications. ACell has five 510(k) premarket notifications for multiple product configurations (sheet, multi-laminate and powder) in wound care and general surgical applications. These clearances enable ACell or a strategic partner to begin immediate commercialization.
» »
» » You should be able to get some of this stuff but you will have to get
» » through a doctor. I hope that it regrows the donor area and provides a
» » limitless supply of donor hair for transplants. I would be shocked if
» it
» » regrew and maintained hair in the bald areas of the scalp, but who
» knows.
» »
» » Take Care,
» » Bill
»
» Problem is that a doctor would not risk aquiring or prescribing some
» because as yet, it is an unknown. And also hasn’t been through human
» trials.
» If I could just get my mitts on some.
I know of two HT doctors that have already been sent shipments and have spoken with another one (vie e-mail) who is trying to get some. He is out of the US. I contacted Acell for him (left a message on their answering machine and e-mailed them) and hopefully he will be able to get a shipment soon.
As far as not being through human trials, it just hasn’t been tested on hair regeneration. It has been used on humans before. Unless I’m misunderstanding something.
Take Care,
Bill
P.S. Two out of three of the above mentioned docs post (or their reps post) in the HT forum on a regular basis so hopefully they will keep us updated on the results.
» » is it allowed?
» »
» » and if so what docs would risk it?
» »
» » isnt the FDA approval required for testing on human trials? if these
» have
» » not taken place how is the product allowed to be on the market other
» than
» » with vets
»
»
» From the Acell Website:
»
» A similar “first generation” ECM technology called SIS (derived from
» porcine small intestine) has been used to treat over 500,000 patients with
» remarkable effect. ACell’s UBM is the next generation of ECM technology due
» to its unique characteristics featuring a basement membrane surface which
» is ideal for epithelial cell growth in many applications.
»
»
» Five FDA 510(k) Clearances for Multiple Clinical Applications. ACell has
» five 510(k) premarket notifications for multiple product configurations
» (sheet, multi-laminate and powder) in wound care and general surgical
» applications. These clearances enable ACell or a strategic partner to begin
» immediate commercialization.
what does that mean? that they have tested a “first generation” of this product before?
what i wonder is, could you even use it for scars and after applying it , the scar will disappear? would be great
anyway, lets hope that in 2-3 months we know if it works for hair and that it does work!
i have a bit fear that you could get cancer from it. my biggest question is, if you get it now, how long do you need to wait that you know you dont get cancer from it? i mean, it would be bad, if you would do it now and you could get cancer from it in 10 years after using it. why im concerned about this is, coz i want to wait a bit and see if its safe. but if i have to wait 10 years or more to see that it doesnt make cancer , that would suck.
does anyone in here have a degree in biology or medicine? could you answer me that question…how long do you have to wait, that you know you didnt get cancer from it? i hope you understand what i mean.
anyway i know someone who studies medicine and one who studies biology. i will ask them, how long you have to wait that you know its safe.
now i think it looks like its no fake (from my point of view), though we still dont know if it works for hair.
SAFETY remains the biggest question. FDA 510 clearance has nothing to do with safety concerns. I couldn’t find anything that confirms that it has been thoroughly tested in a large # of patients. The way they word their website seems to suggest that it was only tested on a very selective group of individuals, on a very small scale.
The powder stimulates cell growth and is made from pigs. I echo the poster who said he is worried about tumors or animal disease being passed onto humans. What’s really worrisome is that they don’t have any FDA trial data on their website.
» SAFETY remains the biggest question. FDA 510 clearance has nothing to do
» with safety concerns. I couldn’t find anything that confirms that it has
» been thoroughly tested in a large # of patients. The way they word their
» website seems to suggest that it was only tested on a very selective group
» of individuals, on a very small scale.
»
» The powder stimulates cell growth and is made from pigs. I echo the poster
» who said he is worried about tumors or animal disease being passed onto
» humans. What’s really worrisome is that they don’t have any FDA trial data
» on their website.
Guys… why you want to search something bad where there isn’t?
You think that a society it’s crazy to put in the market a product that could give serious problems to the patients?
The fda it’s a standard official control procedure to give a certificate, but a product can also be sure without this. If Acell is on market, it’s because is sure. They have already tested it on humans, not for hairs, but it’s already sure proved…
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