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Hair Loss Forum - to CITnews/Dr. Cole, about donor regeneration . . .

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cal

23.10.2013, 23:17
 

to CITnews/Dr. Cole, about donor regeneration . . . (Hair Transplant)

I think I speak for a lot of people when I ask why Dr. Cole's evidence of donor regeneration has not made a bigger collective splash on the HT world in the last couple of years.

I speak here all due respect and no attempts to attack anyone's credibility. But if one of these hair multiplication operations was claiming to be able to pull 1 graft from the donor area and somehow produce 1.5 or 2 grafts in the recipient area from it on average, it would have sent shockwaves through the HT world. That is functionally what Dr. Cole is claiming to see just by using Acell & PRP on low-depth FUE extraction wounds.

I think at least a couple years have gone by since Dr. Cole was first saying this stuff and it has made little impact on the industry. Your clinic is also not posting "WOW" final result HT cases that suggest you have achieved a notable improvement in the ratio between recipient hair gained versus donor hair lost during the HT process.



Has Dr. Cole not yet "swung for the fences" on anyone? Has he not yet attempted to use this regeneration technique to push the limits on how much total MPB restoration is possible for high-Norwood patients?

I could understand that cautious outlook, especially with what is admittedly an inconsistent technique with no long-term data. (What if the regenerated donor follicles eventually succumb to old age decades earlier than normal? etc.) But there are plenty of guys with more hair loss & money than cautiousness and Dr. Cole is making no bones about this regeneration happening - haven't any of his patients wanted to see what this can really do for them?



Are there no other clinics showing interest in what your clinic has been observing with this? Has nobody else tried to test it, etc?

Some respected FUE clinics aren't as interested in cutting-edge HM techniques as others. But this technique/phenomenon seems to offer a huge potential benefit and require very little additional expense/trouble/difficulty/risk to achieve it. There wouldn't be much learning curve, etc, for other clinics to implement it. And the risk of over-harvesting the donor area (betting too high on getting too much regeneration after a given HT session) would not become significant until they were already pushing far enough to see clear evidence that the technique does work to some extent.


Any feedback would be appreciated.




cal is located in [NA] and he is available to meet: NO


Post reply
NeverAgain

24.10.2013, 19:55

@ cal

to CITnews/Dr. Cole, about donor regeneration . . .

Cal, you read my mind, that's exactly how I feel about Cole's PRP & Acell treatment. It has been at least a couple years since it was first announced and really it hasn't made much of an impact in the HT world, it seems as if even Dr. Cole himself is not sure how well that really works or if it works at all.




NeverAgain is located in [NA] and he is available to meet: NO


Post reply
CITNews

Alpharetta,
24.10.2013, 22:58

@ cal

to CITnews/Dr. Cole, about donor regeneration . . .

In order for things to move forward at a quicker pace, there needs to be a LOT more research.

I will be getting updates over the next few days from the annual ISHRS meeting in San Francisco. Please look at my contact information below and feel free to call me. Ask for Chuck.

CITNews works at Dr. Cole's office




CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
hairman2

25.10.2013, 11:44

@ CITNews

to CITnews/Dr. Cole, about donor regeneration . . .

This answer could not have been more evasive.

Originally Posted by CITNews

In order for things to move forward at a quicker pace, there needs to be a LOT more research.

I will be getting updates over the next few days from the annual ISHRS meeting in San Francisco. Please look at my contact information below and feel free to call me. Ask for Chuck.

CITNews works at Dr. Cole's office





hairman2 is located in [NA] and he is available to meet: NO


Post reply
reiner

29.10.2013, 05:30

@ CITNews

to CITnews/Dr. Cole, about donor regeneration . . .

Why are we waiting for the ISHRS? I thought the Dr. Cole was the one who did the PRP and Acell experiments,

Originally Posted by CITNews

In order for things to move forward at a quicker pace, there needs to be a LOT more research.

I will be getting updates over the next few days from the annual ISHRS meeting in San Francisco. Please look at my contact information below and feel free to call me. Ask for Chuck.

CITNews works at Dr. Cole's office





reiner is located in [NA] and he is available to meet: NO


Post reply
cal

13.11.2013, 22:04

@ reiner

to CITnews/Dr. Cole, about donor regeneration . . .

(bump)

Still hoping for a better answer to the original question . . . .




cal is located in [NA] and he is available to meet: NO


Post reply
CITNews

Alpharetta,
19.11.2013, 17:30

@ cal

to CITnews/Dr. Cole, about donor regeneration . . .

Originally Posted by cal

I think I speak for a lot of people when I ask why Dr. Cole's evidence of donor regeneration has not made a bigger collective splash on the HT world in the last couple of years.

Dr. Cole gave a presentation on the benefits of ACell during the recent ISHRS conference in San Francisco. many doctors do full-depth extractions because they believe that adipose (fat) is necessary for hair growth. Full depth extractions do not leave stem cells, so ACell will only improve healing by reducing hypopigmentation.

Remember, doctors are very slow to change and integrate new technologies and medical products. Consider how many years hair transplant doctors placed plugs and mini grafts. One would think, after the first round of results, the plug and mini docs would have been looking at singles and follicular units.


I speak here all due respect and no attempts to attack anyone's credibility. But if one of these hair multiplication operations was claiming to be able to pull 1 graft from the donor area and somehow produce 1.5 or 2 grafts in the recipient area from it on average, it would have sent shockwaves through the HT world. That is functionally what Dr. Cole is claiming to see just by using Acell & PRP on low-depth FUE extraction wounds.

At this stage with ACell we are preserving some donor density. We are working on improving this. It isn't as simple as it would seem on the surface.

I think at least a couple years have gone by since Dr. Cole was first saying this stuff and it has made little impact on the industry. Your clinic is also not posting "WOW" final result HT cases that suggest you have achieved a notable improvement in the ratio between recipient hair gained versus donor hair lost during the HT process.

ACell is improving beard hair yield from approx. 60% to 90% and PRP/ACell + ATP improves healing and graft survival. Wow results continue to be largely dependent upon donor characteristics.

Has Dr. Cole not yet "swung for the fences" on anyone? Has he not yet attempted to use this regeneration technique to push the limits on how much total MPB restoration is possible for high-Norwood patients?

Scalp hair, beard hair, and chest hair plus ACell, PRP, ATP definitely open up greater possibilities for Norwood 6 patients. We commonly see patients get relief to their satisfaction mainly in the frontal area and they are not very concerned about thin hair in the back. There is also the photo release issue. About half of our patients demand the highest level of privacy.

I could understand that cautious outlook, especially with what is admittedly an inconsistent technique with no long-term data. (What if the regenerated donor follicles eventually succumb to old age decades earlier than normal? etc.) But there are plenty of guys with more hair loss & money than cautiousness and Dr. Cole is making no bones about this regeneration happening - haven't any of his patients wanted to see what this can really do for them?

Off the top of my head, roughly 10% of our patients are in the higher Norwood ranges. Roughly half of those patients request complete privacy.

cal:
Are you in the Atlanta area?




Are there no other clinics showing interest in what your clinic has been observing with this? Has nobody else tried to test it, etc?

There are many other clinics using extracellular matrix products. Those clinics who perform minimal depth extractions will be seeing follicle regeneration as long as they are using the product properly and use a reliable method of keeping the extracellular matrix product in contact with the donor extraction sites during the healing process.

Some respected FUE clinics aren't as interested in cutting-edge HM techniques as others. But this technique/phenomenon seems to offer a huge potential benefit and require very little additional expense/trouble/difficulty/risk to achieve it. There wouldn't be much learning curve, etc, for other clinics to implement it. And the risk of over-harvesting the donor area (betting too high on getting too much regeneration after a given HT session) would not become significant until they were already pushing far enough to see clear evidence that the technique does work to some extent.


Any feedback would be appreciated.





CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
NeverAgain

20.11.2013, 19:19

@ CITNews

to CITnews/Dr. Cole, about donor regeneration . . .

Originally Posted by cal

I think I speak for a lot of people when I ask why Dr. Cole's evidence of donor regeneration has not made a bigger collective splash on the HT world in the last couple of years.

Dr. Cole gave a presentation on the benefits of ACell during the recent ISHRS conference in San Francisco. many doctors do full-depth extractions because they believe that adipose (fat) is necessary for hair growth. Full depth extractions do not leave stem cells, so ACell will only improve healing by reducing hypopigmentation.

Remember, doctors are very slow to change and integrate new technologies and medical products. Consider how many years hair transplant doctors placed plugs and mini grafts. One would think, after the first round of results, the plug and mini docs would have been looking at singles and follicular units.


I speak here all due respect and no attempts to attack anyone's credibility. But if one of these hair multiplication operations was claiming to be able to pull 1 graft from the donor area and somehow produce 1.5 or 2 grafts in the recipient area from it on average, it would have sent shockwaves through the HT world. That is functionally what Dr. Cole is claiming to see just by using Acell & PRP on low-depth FUE extraction wounds.

At this stage with ACell we are preserving some donor density. We are working on improving this. It isn't as simple as it would seem on the surface.

I think at least a couple years have gone by since Dr. Cole was first saying this stuff and it has made little impact on the industry. Your clinic is also not posting "WOW" final result HT cases that suggest you have achieved a notable improvement in the ratio between recipient hair gained versus donor hair lost during the HT process.

ACell is improving beard hair yield from approx. 60% to 90% and PRP/ACell + ATP improves healing and graft survival. Wow results continue to be largely dependent upon donor characteristics.

Has Dr. Cole not yet "swung for the fences" on anyone? Has he not yet attempted to use this regeneration technique to push the limits on how much total MPB restoration is possible for high-Norwood patients?

Scalp hair, beard hair, and chest hair plus ACell, PRP, ATP definitely open up greater possibilities for Norwood 6 patients. We commonly see patients get relief to their satisfaction mainly in the frontal area and they are not very concerned about thin hair in the back. There is also the photo release issue. About half of our patients demand the highest level of privacy.

I could understand that cautious outlook, especially with what is admittedly an inconsistent technique with no long-term data. (What if the regenerated donor follicles eventually succumb to old age decades earlier than normal? etc.) But there are plenty of guys with more hair loss & money than cautiousness and Dr. Cole is making no bones about this regeneration happening - haven't any of his patients wanted to see what this can really do for them?

Off the top of my head, roughly 10% of our patients are in the higher Norwood ranges. Roughly half of those patients request complete privacy.

cal:
Are you in the Atlanta area?




Are there no other clinics showing interest in what your clinic has been observing with this? Has nobody else tried to test it, etc?

There are many other clinics using extracellular matrix products. Those clinics who perform minimal depth extractions will be seeing follicle regeneration as long as they are using the product properly and use a reliable method of keeping the extracellular matrix product in contact with the donor extraction sites during the healing process.

Some respected FUE clinics aren't as interested in cutting-edge HM techniques as others. But this technique/phenomenon seems to offer a huge potential benefit and require very little additional expense/trouble/difficulty/risk to achieve it. There wouldn't be much learning curve, etc, for other clinics to implement it. And the risk of over-harvesting the donor area (betting too high on getting too much regeneration after a given HT session) would not become significant until they were already pushing far enough to see clear evidence that the technique does work to some extent.


Any feedback would be appreciated.

Originally Posted by CITNews



Doesn't sound promising




NeverAgain is located in [NA] and he is available to meet: NO


Post reply
CITNews

Alpharetta,
20.11.2013, 19:35

@ NeverAgain

to CITnews/Dr. Cole, about donor regeneration . . .

IMO it's promising. Progress is slower than we like. Breakthroughs in regenerative medicine will have a HUGE impact on improvements in hair restoration technology and results.

CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com




CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
cal

21.11.2013, 05:50

@ CITNews

to CITnews/Dr. Cole, about donor regeneration . . .

Thanks for the answer.

BTW: I am American but I live several states away from the Atlanta area.

I do consider your clinic pretty close compared to many other top level FUE clinics. But that isn't saying much in the FUE industry, with lots of guys flying to foreign continents to get work done.




cal is located in [NA] and he is available to meet: NO


Post reply
damraak

22.11.2013, 06:10

@ CITNews

to CITnews/Dr. Cole, about donor regeneration . . .

CIT, you wrote:

"There are many other clinics using extracellular matrix products. Those clinics who perform minimal depth extractions will be seeing follicle regeneration as long as they are using the product properly and use a reliable method of keeping the extracellular matrix product in contact with the donor extraction sites during the healing process. "


That sounds like Dr. Cole has figured out a way to regenerate the donor using Acell already. But that clearly is not the case considering how few patient results we have seen so far. Care to elaborate?




damraak is located in [NA] and he is available to meet: NO


Post reply
Skywalker

The Corridor of Uncertainty,
22.11.2013, 19:12

@ damraak

to CITnews/Dr. Cole, about donor regeneration . . .

What I get from this is that it works a bit - but even then not very consistently.
In other words it IS promising, but no more than that in the foreseeable future.




Skywalker is located in THE CORRIDOR OF UNCERTAINTY and he is available to meet: NO


Post reply
CITNews

Alpharetta,
22.11.2013, 21:34
(edited by CITNews, 22.11.2013, 22:01)

@ damraak

to CITnews/Dr. Cole, about donor regeneration . . .

Originally Posted by damraak

CIT, you wrote:

"There are many other clinics using extracellular matrix products. Those clinics who perform minimal depth extractions will be seeing follicle regeneration as long as they are using the product properly and use a reliable method of keeping the extracellular matrix product in contact with the donor extraction sites during the healing process. "


That sounds like Dr. Cole has figured out a way to regenerate the donor using Acell already. But that clearly is not the case considering how few patient results we have seen so far. Care to elaborate?


Dr. Cooley and Dr. Mwamba are having success with extracellular matrix products as well. Dr. Wesley acknowledged the regenerative benefits of ACell in his Pilofocus video.

So... There are other doctors having success with extracellular matrix products and Dr. Cole is not the only one.

ACell was approved by the FDA as a regenerative medical product.

The following photo is of an ACell regenerative result from another doctor:

[image]

CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice




CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
jotronic

Homepage

Vancouver, BC Canada,
23.11.2013, 01:32

@ CITNews

Not true. . .

"ACell was approved by the FDA as a regenerative medical product."

With all due respect this is not true. The Acell products being referenced were FDA "cleared" under the 510K clearance protocol for predicate devices. This means that the products do not differ substantially from medical devices manufactured before March, 1976 when the Medical Devices Ammendment was approved by Congress. Acell is cleared for wound management and nowhere in the FDA application nor the letter of clearance is "regeneration" or any other similar language mentioned. FDA approval is a completely different process and is not applicable to this product.

http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060888.pdf

That said, I'm not saying Acell works one way or the other but the language should be corrected because it is grossly inaccurate.




jotronic is located in VANCOUVER, BC CANADA and he is available to meet: YES
email hairsite@aol.com to arrange a meeting.

---
[image]
www.HassonandWong.com

All opinions are my own and may not necessarily be shared by Dr. Wong and/or Dr. Hasson.

If you are interested in having an online consultation visit www.hassonandwong.ca


Post reply
ipod

23.11.2013, 02:31

@ CITNews

to CITnews/Dr. Cole, about donor regeneration . . .

Chuck, please help me understand, who is the doctor and what is he trying to prove with this? That Acell will work if the follicle is transected?




ipod is located in [NA] and he is available to meet: NO

---
NW3 -
Propecia /Saw Palmetto
Topical Spiro / Rogaine Foam (quit REMOX IV)
High does vitamin C / Lysine / Nizoral / Tea Tree Oil Shampoo


Post reply
ipod

25.11.2013, 20:25

@ ipod

to CITnews/Dr. Cole, about donor regeneration . . .

Originally Posted by ipod

Chuck, please help me understand, who is the doctor and what is he trying to prove with this? That Acell will work if the follicle is transected?


bump




ipod is located in [NA] and he is available to meet: NO


Post reply
forhair

E-mail

28.11.2013, 17:21

@ ipod

to CITnews/Dr. Cole, about donor regeneration . . .

as CITnews said, it takes time and research to get the data, we have posted some results and progress with PRP/Acell, here are a few of them:

www forum . forhair . com / topic1794.html
http://www.youtube.com/watch?v=FlZ_osaP5Yg
www forum . forhair . com / topic1878.html
www forum . forhair . com / topic1802.html
http://www.hairsite.com/hair-loss/board_entry-id-120297-page-0-category-2-order-last_answer-descasc-DESC.html




forhair is located in [NA] and he is available to meet: YES
email hairsite@aol.com to arrange a meeting.

---
Regards,
-----------
Disclaimer:I am not a physician. My opinions are not necessarily those of Dr. Cole.

Dr. Cole is a sponsor of HairSite. Rankings on HairSite are based on # of successful patient results posted and not affected by sponsorship. Any clinic or doctor can post their patient results in HairSite forum and earn a point for every successful result posted. It is not the mandate of HairSite to track failed or unsuccessful results, readers are advised to do their own research carefully before making a decision about hair transplant and not rely solely on our ranking system.


Post reply
CITNews

Alpharetta,
29.11.2013, 22:04

@ jotronic

Not true. . .

Originally Posted by jotronic

"ACell was approved by the FDA as a regenerative medical product."


That said, I'm not saying Acell works one way or the other but the language should be corrected because it is grossly inaccurate.


If the statement were grossly inaccurate, I doubt ACell would risk placing the term "regenerative" on their website. There are strict laws prohibiting false product claims. See image:

Regenerate limbs? No. Regenerate fingertips? Yes. Regenerate normal skin where scar tissue would be expected? yes.

Regenerate a 2cm strip removed during surgery? NO

[image]

CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com




CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
CITNews

Alpharetta,
29.11.2013, 23:01

@ CITNews

Not true. . .

More "regenerative" declarations:
[image]

CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com




CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
jotronic

Homepage

Vancouver, BC Canada,
30.11.2013, 01:47

@ CITNews

Not true. . .

Your links and screenshots are meaningless because you did not show anything by the FDA that says that Acell is "FDA Approved" for anything much less for "regenerative medicine".

I showed you where the FDA said that Acell is "FDA Cleared" under the 510K protocol for predicate devices for wound management.

You can point to all the webpages and resources you want but until you can point to a link on the FDA website that backs up your claim (FDA approved for regenerative medicine) then you're just putting lipstick on a pig.




jotronic is located in VANCOUVER, BC CANADA and he is available to meet: YES
email hairsite@aol.com to arrange a meeting.

---
[image]
www.HassonandWong.com

All opinions are my own and may not necessarily be shared by Dr. Wong and/or Dr. Hasson.

If you are interested in having an online consultation visit www.hassonandwong.ca


Post reply
licht

30.11.2013, 09:14

@ jotronic

Not true. . .

I think jotronic has a very good point here. Accuracy and precision is very important, especially when you are representing a clinic using the product in question.

The term "regenerative medicine" is a fairly broad one, and the fact that ACell describes themselves as being in that field does not imply that they are suggesting in anyway that their product has been FDA approved for regenerative purposes.

Acell is indicated by the FDA only for wound-management. While obviously wound-management and regenerative medicine have some overlap, to suggest that the FDA has in any way approved or indicated Acell for regeneration of the sort that people are discussing here, such as full or partial regeneration of hair follicles, is disingenuous.

The statement that you originally made, that 'ACell was approved by the FDA as a regenerative medical product.' is simply false.




licht is located in [NA] and he is available to meet: NO


Post reply
CITNews

Alpharetta,
30.11.2013, 15:13

@ licht

Not true. . .

There is a simple, core basic truth here. It is unlawful for a company to make false claims about their product/products, medical or otherwise. ACell would not claim on their Website or literature that their brand of extracellular matrix has regenerative properties without FDA approval of such statements and claims.
FDA Website

"False or Misleading Labeling

Section 502(a) declares that a drug or device is misbranded if its labeling proves false or misleading in any particular. This phrase "false or misleading" is not confined in meaning to untrue, forged, or deceptive. In fact, the word, statement, or illustration may be true in the strict sense of the word; however, the labeling can be deemed by the FDA to be in violation of the law if it proves deceptive to the customer. It is not a necessary condition that the labeling should be flatly and baldly false; the work "misleading" in the Act means that labeling is deceptive if it is such as to create or lead to a false impression in the mind of the reader. A "false impression" may result not only from a false deceptive statement, but may also be instilled in the mind of the purchaser by ambiguity or misdirection. It may also be caused by failure to inform the consumer of facts that are relevant to those statements actually made. In other words, the label that remains silent as to certain consequences may be as deceptive as the label that contains extravagant claims."


Extracellular Matrix products have very limited effectiveness in the strip surgery field, so it's little wonder Jotronic is downplaying the effectiveness of ACell.

Shouldn't the important debate be one regarding the effectiveness of extracellular matrix products?

Chuck
Dr. Cole's office




CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
Aran Linvail

30.11.2013, 21:19

@ CITNews

Not true. . .

Do you have evidence that Acell has been "approved" rather than "cleared" the way Jotronic puts it?

I think jotronic is on solid ground here.




Aran Linvail is located in [NA] and he is available to meet: NO

---
Poster formerly known as "KO"


Post reply
jotronic

Homepage

Vancouver, BC Canada,
30.11.2013, 21:41

@ CITNews

Not true. . .

Over the years various industries have noted the weight and effectiveness of the words "FDA Approved". It injects a sense of confidence and trust that the consumer can feel good about. If the FDA "approves" of something, it must be an indicator that the product is not only safe but it does what it claims to do.

Remember the laser hair restoration fad from several years back? The lasercombs, the helmets, the doohickys? There was only one company that received FDA 510K clearance for their product; the Lexington Laser Comb. Once that happened it opened a flood gate of competing products stating that the technology (note, not their own particular product)was "FDA Approved". This was an obvious lie but it was very effective because I had countless people calling me saying that they were told their laser thingy was FDA approved and I had to explain why it was not. It was a massive waste of my time but I at least helped to educate a few people about these pieces of junk. Turns out, they are no different than laser pointers. Same class of laser, same wattage variances, no different than a laser pointer you can get from Office depot for ten bucks. The amount of laser cap BS at the ISHRS conference last month in San Francisco, in the vendor section, was a joke.

The laser comb was cleared by the FDA with a 510K clearance because it was engineered and built in a similar fashion with no unique technology to any similar products that were marketed before 1976. In 1976 congress granted the FDA governing authority over medical devices. Problem is, before 1976, there were so many products on the market that the FDA could not possibly hope to take them all off of the market and evaluate each and every piece of medical equipment for an actual approval. So a 510K clearance was created and is essentially a grandfather clause that allows any new product to gain clearance if it shows "substantial equivalence" to products ALREADY ON THE MARKET BEFORE 1976!

This means that in order to gain clearance, regardless of the super human properties that the product may have, the manufacturer must downplay their product as being no different than anything else on the market before 1976. They have to show similar manufacturing, similar materials in the engineering of the product and a similar intended use. The moment they mention anything outside of these parameters as being one of the intended uses for the product, BAM!, they set the whole process back by years, and millions of dollars, in order to prove the claims.

510K clearance is the fast track to being allowed to sell a medical device in the US (and this is a medical device). Had Acell tried to push this through the FDA as being a regenerative medical device then they would have to prove without a shadow of a doubt that indeed that is what this product does, which it does not except in some cases. What ACell CAN do, but not always, is help to create a more ideal environment for healing.

What Acell the company does or does not do or say on their website is irrelevant. YOU stated "FDA approved for regenerative medicine". No where on the FDA website does Acell show FDA approval for ANYTHING much less "regenerative medicine". It is FDA cleared under the 510K clearance protocol for wound management and is no different, in the eyes of the FDA, as any other wound management device that has incorporated porcine derived ingredients over the past forty years.




jotronic is located in VANCOUVER, BC CANADA and he is available to meet: YES
email hairsite@aol.com to arrange a meeting.

---
[image]
www.HassonandWong.com

All opinions are my own and may not necessarily be shared by Dr. Wong and/or Dr. Hasson.

If you are interested in having an online consultation visit www.hassonandwong.ca


Post reply
licht

01.12.2013, 07:39

@ CITNews

Not true. . .

There is one basic core truth here, and that is that Acell does not have the sort of FDA approval you claimed.

The passage you quoted regarding false claims is completely irrelevant to the discussion. Nobody is saying that Acell is making false claims. They weren't the ones claiming to have FDA approval for regenerative purposes. You were.

There is nothing wrong with making an honest mistake, and retracting your claim once you realize you were wrong. It is a bit concerning however that the representative of a clinic using the product in question is so unconcerned with the accuracy of his claim that the product has FDA approval.

It is also concerning that rather than effectively addressing the issue, you try to imply that jotronic's statement is less legitimate because he happens to work at a clinic that performs strip surgery. That simply has no bearing whatsoever on the accuracy of his statement.

FDA records are online and easily accessible. A quick Google search will provide you with the 501k clearance documentation for Acell (including the predicate device that Acell and the FDA felt were functionally similar). If you really believe that Acell has some sort of FDA approval over and beyond this, please show us the approval documentation. Of course, you will find none, because none exists.

None if this is to say that Acell isn't effective for regenerative purposes of the sort your clinic is investigating. It may well be, and the investigation is very much worth undertaking. However, to claim that Acell is FDA approved is simply incorrect.

If you want to demonstrate the effectiveness of Acell (and I do hope it is effective) then why not share the specific results of your experimentation (graft and regrowth counts, close up photos of tattooed areas).




licht is located in [NA] and he is available to meet: NO


Post reply
hairdar

01.12.2013, 17:48

@ jotronic

Not true. . .

Originally Posted by jotronic

Over the years various industries have noted the weight and effectiveness of the words "FDA Approved". It injects a sense of confidence and trust that the consumer can feel good about. If the FDA "approves" of something, it must be an indicator that the product is not only safe but it does what it claims to do.

Remember the laser hair restoration fad from several years back? The lasercombs, the helmets, the doohickys? There was only one company that received FDA 510K clearance for their product; the Lexington Laser Comb. Once that happened it opened a flood gate of competing products stating that the technology (note, not their own particular product)was "FDA Approved". This was an obvious lie but it was very effective because I had countless people calling me saying that they were told their laser thingy was FDA approved and I had to explain why it was not. It was a massive waste of my time but I at least helped to educate a few people about these pieces of junk. Turns out, they are no different than laser pointers. Same class of laser, same wattage variances, no different than a laser pointer you can get from Office depot for ten bucks. The amount of laser cap BS at the ISHRS conference last month in San Francisco, in the vendor section, was a joke.

The laser comb was cleared by the FDA with a 510K clearance because it was engineered and built in a similar fashion with no unique technology to any similar products that were marketed before 1976. In 1976 congress granted the FDA governing authority over medical devices. Problem is, before 1976, there were so many products on the market that the FDA could not possibly hope to take them all off of the market and evaluate each and every piece of medical equipment for an actual approval. So a 510K clearance was created and is essentially a grandfather clause that allows any new product to gain clearance if it shows "substantial equivalence" to products ALREADY ON THE MARKET BEFORE 1976!

This means that in order to gain clearance, regardless of the super human properties that the product may have, the manufacturer must downplay their product as being no different than anything else on the market before 1976. They have to show similar manufacturing, similar materials in the engineering of the product and a similar intended use. The moment they mention anything outside of these parameters as being one of the intended uses for the product, BAM!, they set the whole process back by years, and millions of dollars, in order to prove the claims.

510K clearance is the fast track to being allowed to sell a medical device in the US (and this is a medical device). Had Acell tried to push this through the FDA as being a regenerative medical device then they would have to prove without a shadow of a doubt that indeed that is what this product does, which it does not except in some cases. What ACell CAN do, but not always, is help to create a more ideal environment for healing.

What Acell the company does or does not do or say on their website is irrelevant. YOU stated "FDA approved for regenerative medicine". No where on the FDA website does Acell show FDA approval for ANYTHING much less "regenerative medicine". It is FDA cleared under the 510K clearance protocol for wound management and is no different, in the eyes of the FDA, as any other wound management device that has incorporated porcine derived ingredients over the past forty years.


Excellent educational post Joe, really deserves to be sticked or become a permanent feature story on Hairsite.




hairdar is located in [NA] and he is available to meet: NO

---
George Taylor: There's your Minister of Science; honor-bound to expand the frontiers of knowledge...
Dr. Zira: Taylor, please!
George Taylor: ...except that he's also chief Defender of the Faith!
Dr. Zaius: There is no contradiction between faith and science... true science!
George Taylor: Are you willing to put that statement to the test?
Cornelius: Taylor, I would much rather...
George Taylor: Take it easy... you saved me from this fanatic, maybe I can return the favor!


Post reply
CITNews

Alpharetta,
01.12.2013, 18:28

@ licht

Not true. . .

Originally Posted by licht

It is a bit concerning however that the representative of a clinic using the product in question is so unconcerned with the accuracy of his claim that the product has FDA approval.


I could understand someone such as yourself and Jotronic nit picking if regenerative medicine were a fairy tale. The motive of your criticism relates to the threat regenerative medicine poses to the strip surgery industry.

If ACell didn't have regenerative properties, it would be nothing more than an overpriced bandage. Who would buy it?

If you have ever consulted with a representative of a government agency, you know that they are people who want a life just like everyone else and commonly have stacks of paperwork virtually no one on earth would want to deal with. They are motivated to keep their job as free from unnecessary complexities as are for instance, those seeking FDA approval of products. FDA approval even at the most basic level is not a walk in the park as Jotronic suggests. I personally know someone whose job involves securing FDA approval for medical devices. He often consults with FDA representatives by phone during the process. The paperwork and hoops to jump through are mind boggling. FDA representatives are made well aware of the details of products presented to them. The FDA is not going to create an elaborate customized category for every product presented to them. If a product qualifies under simpler, more generic guidelines, that will be the route taken. That's in everyone's interest. I have no doubt that the FDA representatives involved in ACell's approval process are well aware that ECM has regenerative properties. ACell already has multiple FDA approvals allowing its ECM to be placed in humans.

Is ACell approved by the FDA for sale to physicians in the United States?
Yes

Do ACell's extracellular matrix products have regenerative properties?
Yes


CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com




CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
licht

01.12.2013, 18:55

@ CITNews

Not true. . .


Originally Posted by CITNews


I could understand someone such as yourself and Jotronic nit picking if regenerative medicine were a fairy tale. The motive of your criticism relates to the threat regenerative medicine poses to the strip surgery industry.


This is absolutely untrue, and a totally unnecessary ad hominem attack. While I can't speak for jotronic, I can say that I have no interest whatsoever in the effect that regenerative medicine poses to strip surgery. None whatsoever. I'm only interested in making sure that the information here is as accurate as possible. That you would imply otherwise simply to try to cast doubt on the points I am making, indicates that you obviously not able to counter what we are saying using facts and reasoning.


If ACell didn't have regenerative properties, it would be nothing more than an overpriced bandage. Who would buy it?


Nobody is saying that ACell doesn't have regenerative properties. Once again, you are misdirecting the argument. We are saying that, contrary to your claim, the FDA has not approved Acell as a regenerative product.

If you have ever consulted with a representative of a government agency, you know that they are people who want a life just like everyone else and commonly have stacks of paperwork virtually no one on earth would want to deal with. They are motivated to keep their job as free from unnecessary complexities as are for instance, those seeking FDA approval of products. FDA approval even at the most basic level is not a walk in the park as Jotronic suggests.


Once again, misdirection. Jotronic did not, as far as I can tell, suggest that FDA approval was a walk in the park. How difficult or easy it is to get FDA approval for a product is not relevant at all. What is relevant is whether or not that process has been followed for Acell with regards to regenerative medicine, and it hasn't. Just because the process is onerous doesn't somehow give you the right to claim that Acell is FDA approved for regeneration when it is not.

That's in everyone's interest. I have no doubt that the FDA representatives involved in ACell's approval process are well aware that ECM has regenerative properties. ACell already has multiple FDA approvals allowing its ECM to be placed in humans.


First, Acell was not approved. It was cleared for sale. These are two very different things. Approval implies that the product has demonstrated its efficacy for a certain indication through a process of double-blinded, placebo-moderated clinical trials. Acell has not gone through that process.

The differences between clearance and approval when it comes to medical devices is given in a very clear way on the FDA website. FDA approval is a far more rigorous process which involves, among other things, that proof of efficacy of the claims in question be made. That process was not done for Acell.



Is ACell approved by the FDA for sale to physicians in the United States?
Yes

Do ACell's extracellular matrix products have regenerative properties?
Yes


This is ridiculously faulty reasoning. The fact that Acell is cleared for sale in the United States, and that it seems to at times exhibit regenerated properties in no way implies that the product is FDA approved for regenerative purposes.

The FDA has made absolutely no statement, implied or otherwise about ACell's efficacy as a regenerative product by giving clearance for its sale. Clearance was given simply based on its similarity to a predicated product which also had 501k clearance.

I should also note that it is worrisome that you consider it nitpicking that we are concerned when the representative of a clinic who uses a particular product makes false statements about that product's status with the FDA. This is no small matter.

Once again, your statement "The statement that you originally made, that 'ACell was approved by the FDA as a regenerative medical product.' is simply false.




licht is located in [NA] and he is available to meet: NO


Post reply
CITNews

Alpharetta,
01.12.2013, 20:41

@ licht

Not true. . .


Once again, your statement "The statement that you originally made, that 'ACell was approved by the FDA as a regenerative medical product.' is simply false.


If you look up the the word "approve", there are several definitions:

1. to speak or think favorably of; pronounce or consider agreeable or good; judge favorably: to approve the policies of the administration.

2. to consent or agree to: Father approved our plan to visit Chicago.

3. to confirm or sanction formally; ratify: The Senate promptly approved the bill.

Within the context of FDA policy and language, I agree with you. By stating "ACell was approved by the FDA as a regenerative medical product", I wasn't attempting to mislead anyone as you imply. Rather I was using the number 2 definition of the word "approve" appearing in the dictionary:
The FDA has given consent and has agreed to allow, the company, ACell to sell their brand of regenerative, extracellular matrix products to physicians. This is what I meant and it was not my intention for it to collide with FDA terminology or cause misrepresentation or confusion.

Representatives of Clinics strive to be as accurate as possible, but simply don't have the time or resources to consult with an attorney, scientist or government representative before every post they make in the forums. Minor errors in the wording of statements will occur from time to time.

I could seriously nit pick statements Jotronic has made in the past, even Dr. Hasson. We don't agree on a lot of things. I prefer to keep things positive and report news that benefits hair loss sufferers.

My whole reason for bringing up the FDA was to diffuse some of the hope hair loss sufferers have in unproven experimental products. I believe that ECM products will play an important role in the future improvement of hair loss treatments.



CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com




CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
Dmark

01.12.2013, 23:02

@ CITNews

Not true. . .

My whole reason for bringing up the FDA was to diffuse some of the hope hair loss sufferers have in unproven experimental products. I believe that ECM products will play an important role in the future improvement of hair loss treatments.

Your statement looks very worrying to me especially considering you are a rep. of major clinic - what excatly do you mean you were bringing FDA up just to diffuse some hope in unproven experimental products??
On top of that Dr Cole has supposed to prove ECM mentioning for more than 2 years that he has experienced regeneration using Acell ( recently i have red somewhere an average of 50% regeneration ) or is it a result of my misunderstanding?? Personally I am still waiting for the pics and it s more than 2 years you are going on with this acell regeneration without any facts to prove that.




Dmark is located in [NA] and he is available to meet: NO


Post reply
CITNews

Alpharetta,
01.12.2013, 23:56

@ Dmark

Not true. . .

Originally Posted by Dmark

My whole reason for bringing up the FDA was to diffuse some of the hope hair loss sufferers have in unproven experimental products. I believe that ECM products will play an important role in the future improvement of hair loss treatments.

Your statement looks very worrying to me especially considering you are a rep. of major clinic - what excatly do you mean you were bringing FDA up just to diffuse some hope in unproven experimental products??
On top of that Dr Cole has supposed to prove ECM mentioning for more than 2 years that he has experienced regeneration using Acell ( recently i have red somewhere an average of 50% regeneration ) or is it a result of my misunderstanding?? Personally I am still waiting for the pics and it s more than 2 years you are going on with this acell regeneration without any facts to prove that.


We HAVE posted pictures of extraction sites growing hair. Dr. Wesley included a picture showing follicle regeneration in his Pilofocus video. Dr. Cooley has had success with follicle regeneration. Dr. Mwamba in Belgium is reporting follicle regeneration with an extracellular matrix product, just to name a few. When we post photos, a common criticism is, "You left the follicle of the growing hair in the extraction site when you removed the graft."

Many doctors getting follicle regeneration don't want to come forward simply because they don't want to take heat in the forums. Dr. Cole told me privately that he has a difficult time himself, believing that he is getting follicles to regenerate with ACell. Dr. Cole began using ACell to improve hypopigmentation of extraction sites. When he began seeing donor sites where he extracted, for example, 3,000 grafts looking fuller than they should, he began counting hairs. The hair counts in extraction sites would begin when patients came back 8 months to one year post-op for an additional shaven procedure. Dr. Cole keeps track of follicle regeneration in an Excel spreadsheet.

As more doctors start using extracellular matrix products, it's only a matter of time before the hair loss community accepts the reality of follicle regeneration.

My view of ACell is that it's not in the experimental phase, but rather, a phase of widespread use by doctors in many fields of medicine where delivery methods and product effectiveness is being improved.

CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com




CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
Dmark

02.12.2013, 00:12

@ CITNews

Not true. . .

WOW!! you are declaring completely opposite things in each reply !! Now you don t want to bring up any hope anymore but everything is proven and apparently also Dr Cooley and Dr Mwamba has proven that - is the same Dr Mwamba who went to the Dr Nigam who also has proven regeneration right ? Only us bald guys we havent proven any of these regeneration cures that seems many doctors have at the moment!

Sorry which evidences you have provided ?? The one attached above?? Do you believe those are evidences ?? If you really believe those are evidences good enough you really joking!
I am very disappointed as i tought at least Dr Cole clinic were belongin to the few serious and trustworth clinics worldwide but at this point this clnic has lost all his credibility to me saying the same bs for the last 2 years.




Dmark is located in [NA] and he is available to meet: NO


Post reply
cal

02.12.2013, 01:32

@ Dmark

Not true. . .

Chill out Dmark.

So Dr. Cole and some others may be seeing a certain degree of regeneration occurring, but they aren't willing to tackle all the implications of making that the central thing their HT work has going for it. I find that scenario entirely plausible.


I think Dr. Cole is getting ahead of himself making claims of 50% regeneration. But IMO the guy generally seems to go out on limbs when he talks on lots of HT topics. Making some big unproven regeneration claims does not seem uncharacteristic of him in that sense.


The whole thing would feel much more dishonest if Cole & other FUE docs were making a big sales push out of the idea that Acell is regenerating donor hair. Also, if they were promising airtight proof in all sorts of specific ways and never delivering it.

But so far I don't see that stuff happening. I just see assertions that some donor regeneration is believed to be happening at this stage. These clinics seem to basically still be attracting patients on the idea that they will receive a traditional FUE transplant, and giving patients the option of messing with Acell for possible extra benefit.




cal is located in [NA] and he is available to meet: NO


Post reply
CITNews

Alpharetta,
02.12.2013, 01:48

@ Dmark

Not true. . .

Originally Posted by Dmark

WOW!! you are declaring completely opposite things in each reply !! Now you don t want to bring up any hope anymore but everything is proven and apparently also Dr Cooley and Dr Mwamba has proven that - is the same Dr Mwamba who went to the Dr Nigam who also has proven regeneration right ? Only us bald guys we havent proven any of these regeneration cures that seems many doctors have at the moment!

Sorry which evidences you have provided ?? The one attached above?? Do you believe those are evidences ?? If you really believe those are evidences good enough you really joking!
I am very disappointed as i tought at least Dr Cole clinic were belongin to the few serious and trustworth clinics worldwide but at this point this clnic has lost all his credibility to me saying the same bs for the last 2 years.


Not sure what you're talking about regarding opposite replies. Can you provide an example?

The photo earlier in the post is one Dr. Wesley included in his Pilofocus video. This is not an example of our clinic's success with follicle regeneration.

I'm having a similar discussion in another forum... Men placed their hopes in the research Aderans engaged in for about eight years. The first year they produced a video that implied they could already multiply hair. Years later, they have nothing. Histogen did not provide convincing photography of their product success at last year's ISHRS meeting. This year they were a no-show in San Francisco. It's not that we don't want Histogen to be successful. I hope they flat out discover a cure and their employees become millionaires and billionaires.

I'm just trying to bring a realistic focus here. Nearly anything can happen. Perhaps Histogen will overtake extracellular matrix products with regards to overall effectiveness in the field of hair restoration. The truth is as of December 1, 2013 extracellular matrix products are the dominant player/leading product in the field of hair restoration with regards to regenerative success.

CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com




CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
licht

02.12.2013, 06:22
(edited by licht, 02.12.2013, 07:07)

@ CITNews

Not true. . .


Originally Posted by CITNews

If you look up the the word "approve", there are several definitions:


Obviously, words can have different meanings in different contexts. When we are talking about "FDA approval" in terms of a medical product or device, the meaning is specifically defined by the FDA, and the word has very specific and important implications about the rigor to which that product has been put, in terms of proving its efficacy and safety in that area. It implies a level of testing and verification that has simply not been applied to ACell.

Other meanings of "approval" in other contexts are not relevant to a discussion about a product and its FDA status by a rep from a clinic.


Within the context of FDA policy and language, I agree with you. By stating "ACell was approved by the FDA as a regenerative medical product", I wasn't attempting to mislead anyone as you imply. Rather I was using the number 2 definition of the word "approve" appearing in the dictionary:
The FDA has given consent and has agreed to allow, the company, ACell to sell their brand of regenerative, extracellular matrix products to physicians. This is what I meant and it was not my intention for it to collide with FDA terminology or cause misrepresentation or confusion.


I wasn't attempting to imply that you were intentionally meaning to mislead people. I have a feeling that you simply didn't know at the beginning, that you thought it was FDA approved, but it turned out not to be. Whatever the case is, at least now you know (and everybody else here does too).

The FDA has given consent to allow ACell to physicians, because of its similarity to wound-healing devices from before. We have to be very, very clear here that the FDA doing so does not imply in the slightest that the FDA believes this has been proven in any way whatsoever to have a regenerative effect of the sort that you are hoping for in your experiments. The FDA has made no decision whatsoever on ACell as a regenerative product. ACell has not gone through the requisite trials, and may never will.

My whole reason for bringing up the FDA was to diffuse some of the hope hair loss sufferers have in unproven experimental products. I believe that ECM products will play an important role in the future improvement of hair loss treatments.


It's hard to really understand what your above sentence is supposed to be saying. ACell is, in terms of hair loss, or regeneration in general, an unproven experimental product as far as the FDA goes. The FDA has not approved it for those uses. When you brought up the FDA, especially in terms of approval, it implies that ACell has some sort of certification from the FDA that it does not. The FDA has simply cleared ACell for sale, based on its similarity to other products with respects to wound healing, and not regeneration in any broader sense.

So while again I couldn't fully understand that last sentence, if you were trying to distinguish ACell from other unproven experimental products, then by invoking the FDA, you were in fact being misleading.

Again, I don't think it was intentional. I think you just weren't fully aware or informed about the actual FDA status of ACell, but now you know. You can cease to refer to ACell as FDA approved, cease to imply that the FDA has in any way vetted ACell for regenerative purposes at all, and then no harm, no foul.

All of this doesn't mean that you can't use it, or experiment with it. I think it's great that some Doctors are experimenting with new techniques, and hopefully getting good results with it.

If you really want to demonstrate to us that ACell is successful in regenerating follicles, do so by applying some scientific rigor to the sample patients you are working with, and performing accurate graft counts and tattoo centered photographs.




licht is located in [NA] and he is available to meet: NO


Post reply
CITNews

Alpharetta,
02.12.2013, 16:02

@ licht

Not true. . .

The Title I'm responding to here is "Not True". This opens up another question worthy of debate... Is a government agency's determination or ruling regarding "truth" always reliable, accurate and moral?

Examples:
1.) A friend of ours is a tax attorney. While doing a client's taxes, she came across an IRS policy statement that was unclear to her. She called the IRS office and spoke with an appropriate individual regarding a vague paragraph. The IRS agent gave an explanation that made no sense to her, so she called back and spoke to another IRS agent. This time she got a completely different answer. That answer didn't make sense either so our tax attorney friend applied her own interpretation to complete her client's taxes. She expressed to me that the IRS tax code is so complicated, the IRS doesn't even understand it.

2.) We have a creek in our backyard that FEMA determined after a survey, endangered some properties in our neighborhood. later, two homes determined to be in the safe zone were flooded, one with 5' of water. Other homes that FEMA required buy flood insurance, did not have any flood problems whatsoever when the floods came. We are one of the homeowners in our neighborhood required to buy flood insurance and our home has never flooded.

3.) A neighbor living in the Atlanta area bought a home in the close-by city of Alpharetta. Real estate paperwork was sent to California by error because a "GA" was interpreted as a "CA". When the California taxing authorities got a hold of the real estate document, they saw that no California property taxes were ever paid. The homeowner of course protested and argued that the city of Alpharetta does not exist in California. That didn't matter to the California taxing authority and they placed a lien on the man's home. He contacted an attorney after going round and round and his attorney recommended he just pay the $8,000 (approx.) they required because it would cost more to fight them in court.

4.) Remember the film "Trading Places". Aaron Russo was the producer of that film and also ran for governor of Nevada. At one time he was a big gold and silver trader. He got a notice from the IRS that a particular tax deduction he took on some previous year's taxes was no longer legal. The IRS made the law retroactive, so even though he took a legal deduction in previous years, they required payment of recalculated previous-year taxes as if the legal deduction he took at the time had been illegal.

5.) A friend of ours, step father lives in Marathon Florida. He bought a Norwegian fishing vessel to restore and use like one would use a yacht. The first time out, he headed for Maine. He was constantly boarded by the coast guard because the ship was in a database of possible drug-running vessels. At that time the coast guard didn't communicate between the various jurisdictions when a ship was "cleared". Our friend's step dad grew tired of the constant harassment by the coast guard and expressed his complaint. He was arrested and his boat was impounded. He was fined $85,000 and a judge didn't seem to think that was wrong. This story ran in the Washington Post.

Debates can be similar to boxing. Remember Muhammad Ali's rope a dope? Confuse and conquer?

Often real-world common sense carries more weight than government agency endorsement.


From the FDA glossary of terms
Biological Product
Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

FDA approves new drugs and biologics:
New drugs and biologics must be proven safe and effective to FDA's satisfaction before companies can market them. FDA does not develop or test products; FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers.
If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.

The above could be interpreted to mean that tissues (ACell is made from pig tissue) require approval before they can be marketed. The FDA gives a broad meaning to what is classified as biologics.

Is the FDA using the word approval in the context of their proprietary meaning such as "Approved of Cleared" or are they using one of the common dictionary definitions?

Discussions such as this can waste a great deal of time. Personally I believe that often times proving a product's efficacy in real-world application has more legitimacy than an agency's rubber stamp.


CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com




CITNews is located in ALPHARETTA and he is available to meet: NO

---
CITNews works for Dr. Cole's clinic in Atlanta
Cole Hair Transplant
Phone 678-566-1011
FREE CONSULTATION


Post reply
licht

02.12.2013, 16:27

@ CITNews

Not true. . .

Originally Posted by CITNews

The Title I'm responding to here is "Not True". This opens up another question worthy of debate... Is a government agency's determination or ruling regarding "truth" always reliable, accurate and moral?

Examples:



Honestly, I don't see the relevance in these examples at all. Nobody is claiming that any government agency's determination is necessarily accurate, reliable or moral. Nobody is claiming that the FDA is the be-all end-all arbiter of what works and what doesn't.

We're simply stating that your statement, that "ACell was approved by the FDA as a regenerative medical product" is outright false and misleading.

A very simple outline of the difference between "approval" and "clearance" in terms of the FDA is given here, on the FDA's website.

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm

There is nothing confusing about it at all, and nobody is trying to confuse this debate. ACell is not, as you said, approved by the FDA as a regenerative medical product. It is as simple as that.

When you quoted from the FDA's website a passage that referred to approval, obviously they were using their own narrow and specific definition of the word approval, which means it has gone through a process demonstrating reasonable safety and efficacy for a particular indication. ACell has NOT gone through that process for regeneration, and is there for NOT approved by the FDA for that indication.

In fact, it hasn't been approved for any indication, but rather cleared for use under the 501k pathway, because it is substantially similar to either device that existed prior to current legislation, or a predicate device that also achieved clearance under the 501k pathway.

To say that it has been approved for regenerative medicine is misleading, as it implies incorrectly that the FDA has in some way attempted to verify the efficacy of ACell in that field, which it HAS NOT.


Discussions such as this can waste a great deal of time. Personally I believe that often times proving a product's efficacy in real-world application has more legitimacy than an agency's rubber stamp.


I disagree very much that this discussion is a waste of time. Claiming something is FDA approved when it is not is no light issue. If you think that the FDA's "rubber stamp" is illegitimate fine. Just don't claim that a product has that "rubber stamp" when it doesn't.




licht is located in [NA] and he is available to meet: NO


Post reply
reiner

02.12.2013, 18:05

@ licht

Not true. . .

Good discussion. Can someone tell me why they call Acell a device? From the pictures I have seen, Acell is some kind of powder which to me is more in the category of medical treatment rather than a device.

When people talk about device, I am thinking of a gadget, for example lasercomb is a device.




reiner is located in [NA] and he is available to meet: NO


Post reply
CITNews

Alpharetta,
02.12.2013, 18:06

@ licht

Not true. . .

Originally Posted by licht


Honestly, I don't see the relevance in these examples at all. Nobody is claiming that any government agency's determination is necessarily accurate, reliable or moral.


If you don't have confidence that the FDA's determinations are necessarily accurate, reliable or moral, then why bother put the effort into defending their proprietary terms and regulations?

To say that it has been approved for regenerative medicine is misleading, as it implies incorrectly that the FDA has in some way attempted to verify the efficacy of ACell in that field, which it HAS NOT.


The FDA states on their Website that they do not test products.


I disagree very much that this discussion is a waste of time. Claiming something is FDA approved when it is not is no light issue. If you think that the FDA's "rubber stamp" is illegitimate fine. Just don't claim that a product has that "rubber stamp" when it doesn't.


I just spent some time in the office of an associate whose job involves working with the FDA with regards to medical devices. When I first stepped into his office this morning, I said; I have a question for you about FDA "Approval" and "Clearance". By the look on his face, his blood pressure appeared to have shot up. He showed me the official FDA forms required for the most basic clearance. The form has a field that requires complete information related to how the applicant intends to market their product. I have no doubt ACell had to reveal to the FDA, marketing words and phrases they intended to use, such as "regenerative". The FDA has essentially "black and white" guidelines regarding claims and false claims. You say it's false and misleading to state that the FDA had to approve of the marketing claims made by ACell. Acell certainly wouldn't make claims in their marketing without FDA approval. There's that word again.


I stand by my statement that the company ACell wouldn't claim on their Website or in their marketing material that their products have regenerative properties without FDA consent or to use the term generically, "approval".

Scientists from ACell have been working with the US government on at least one regenerative medicine research project I'm aware of.

IMO, It appears to me that what you claim is "false" is a legalistic stretch and I also didn't state that the FDA's "rubber stamp" is illegitimate at all. I just stated that a government agencies declaration or evaluation isn't ALWAYS reliable. That was the purpose of my previous post. And yes it is VERY relevant. Obviously not to you because it doesn't support your tedious arguments.

CITNews works at Dr. Cole's office
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I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com




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Post reply
CITNews

Alpharetta,
02.12.2013, 21:31
(edited by CITNews, 02.12.2013, 22:00)

@ CITNews

Not true. . .

Dr. Ron and Paul Shapiro refer to ACell as approved (ouch) on their Website.

Jotronic wrote:
"Over the years various industries have noted the weight and effectiveness of the words "FDA Approved". It injects a sense of confidence and trust that the consumer can feel good about. If the FDA "approves" of something, it must be an indicator that the product is not only safe but it does what it claims to do."

ACell's products are classified as a medical device. According to information on the FDA's Website, medical devices are "Cleared" not "Approved". So in other words, when the FDA gives a product the green light for sale, if it's classified as a device, they "clear" it. On the other hand, certain drugs must undergo what the FDA calls an "approval" process.

So it's not like a medical device will graduate some day to a higher status called "Approved"

The FDA on its own Website calls "Clearance" an approval process. It's just a different term they use to distinguish medical devices from other products like prescription drugs:

"FDA Approval Process for Medical Devices

The 510(k) process applies to most Class II medical devices sold in the US and a small number of Class I and Class III devices as well. Technically, the FDA does not "approve" medical devices; they "clear" them for sale. Once a FDA 510(k) number has been granted, it does not expire. However, you must remain in compliance with all FDA regulations to continue selling your product in the US. The FDA may visit your facility at any time to conduct an inspection to ensure you are in compliance with the Quality Systems Regulation (QSR), 21 CFR Part 820. If you are not sure whether your product requires a 510(k), see our easy to understand 7-step guide. We will lead you through the process.
- See more at: Here"

So technically it isn't an egregious falsehood as some suggest to say that "Clearance" is approval. The FDA on its own Website refers to "Clearance" as an approval process.

CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
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Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com




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Post reply
jotronic

Homepage

Vancouver, BC Canada,
03.12.2013, 00:59

@ CITNews

Not true. . .

Why do you keep linking to and referencing websites that are NOT the FDA? One website is that of Dr. Ron, whom I have a good relationship with, and I'm sure that if asked he would say that he does not work for the FDA nor was he involved in the clearance process. The other is a site run by someone that wants your money to help you with the FDA process. Regardless, the second website you referenced reinforces my point (and negates your intended reference to Dr. Ron's website), whereas Acell is not "approved for regenerative medicine" because...

1.) The FDA does not "approve" class II devices, of which Acell is a class II device. So because "approve" means something else entirely, in the eyes of the FDA, YOU cannot say that "approved" and "cleared" are one in the same. As I said all along, Acell is "cleared", not "approved" and at no time did I reference any graduation to a "higher status" of "approval". This doesn't even make sense.

What you omitted from your quote of the third party website was the next paragraph...

"Essentially, when the FDA sends you this letter, they are not "approving" your device, they are saying that your device is substantially equivalent to the predicate device(s) selected in your 510(k), and which has already been cleared for sale by the FDA, and that you are now cleared to sell your device."

And yet again, this is what I've been saying. With the understanding, finally, that Acell is "cleared" it needs to be understood that it is not "cleared for regenerative medicine". It is cleared based on predicate devices that came before it that have similar engineering and manufacturing along with it's STATED intended use. The second website you referenced (you know, the one that negates the link to Dr. Ron's website?)says THE SAME THING I've been saying!

2.) The language is specific in the official submission of the intended use as well as the confirmation letter from the FDA back to Acell...

...for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscense), trauma wounds (abrasions, lacerations, second degree burns, skin tears) and draining wounds. The device is intended for one time use."

No where in the list above, as provided by Acell and confirmed by the FDA, is the word "regenerative" even remotely used. Again, you cannot point to a single reference on the FDA website that states anything about Acell being "approved" much less "cleared" for "regenerative medicine.

You also stated that Acell would not misbrand their products on their website if the products were not approved by the FDA. Well, they've been warned about a few cases of "misbranding" their products just this year. The full write up is quite interesting...


http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm352061.htm


Finally, you said that I am nitpicking because Acell doesn't work very well for strip. I never once referenced the efficacy of Acell one way or the other. I only said that your are wrong when you say that Acell has been "FDA approved for regenerative medicine. Now you're wrong even when you replace the word "approved" with "cleared" because nowhere is the term "regenerative" medicine used, at all, approved or cleared.




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Post reply
robohair

03.12.2013, 01:52

@ jotronic

Not true. . .

So I gather the approval process for medical devices is called clearance by the FDA. The word used for approved prescription drugs is called approval. I don’t see why that is such a big deal. ACell can sell their products, so that’s great. Shouldn’t patients be more concerned with the real-world effectiveness of a product rather than arguments over the meaning of words?
I also doubt that ACell would refer to their products as having regenerative properties on their Website without FDA approval of such statements.
I also don’t feel that Dr. Cole would use products that aren’t in the best interest his patients.
For me , a strip hair transplant doesn’t seem like a great idea seeing all of the huge scars that are posted in the forums. ACell might give FUE a boost, so I can see why that would concern all the strip supporters.




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Post reply
Dr. Cole

Atlanta, Ga,
03.12.2013, 02:27

@ ipod

to CITnews/Dr. Cole, about donor regeneration . . .

For me, I don't worry as much about what someone says something might do. I am more concerned about what it will do. What good is it for something like intercytex, or Aderans, or Histogen to say they do something? What matters more is what it does.

I've put a ton of road blocks in front of Acell. It has broken through all of them thus far. The most recent study I have going used Acell alone plus a liquid bandage. So far, i have only three regenerated hair follicles. I have zero re-growth of transected hair follicles. It may be that the delivery system is just as important at the Acell itself. Hair follicle stem cells have been shown to repair severed nerves, but gel foam alone can partially improve nerve function in the paralyzed mouse. How we deliver Acell may be more important than Acell itself. This is shaping up to be a very interesting study. Prior studies have shown far more regeneration than this present study where I eliminated the delivery vehicle and used on Prostaglandin up regulators.




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Post reply
jotronic

Homepage

Vancouver, BC Canada,
03.12.2013, 02:29

@ robohair

Not true. . .

Originally Posted by robohair

So I gather the approval process for medical devices is called clearance by the FDA. The word used for approved prescription drugs is called approval. I don’t see why that is such a big deal.


No, it is called "clearance" for class II devices that are exempt from more stringent review because they are no different than named devices that were cleared before them.


ACell can sell their products, so that’s great. Shouldn’t patients be more concerned with the real-world effectiveness of a product rather than arguments over the meaning of words?


Yes, you are exactly right however don't forget that without the right words there is no way to differentiate what is being said. The effectiveness is what patients should be concerned about when it is being represented as something that the FDA has not endorsed.



I also doubt that ACell would refer to their products as having regenerative properties on their Website without FDA approval of such statements.


Well, I'm still waiting for any shred of proof of such FDA approval but the fact of the matter is that the "regenerative" part on Acell's website is for marketing. It is not necessarily false. I know that Acell can help people in need but their own language that they submitted to the FDA has zero mention of any regenerative claims.

I also don’t feel that Dr. Cole would use products that aren’t in the best interest his patients.


I agree but even Dr. Cole will not go out on a limb and say that Acell works. He said this in a thread on a different forum when asked why donor hair is limited even with Acell...

"Great question! Suppose you take out a three hair graft and get only 1 hair to regrow. Suppose you take out 20 grafts and get only 50% of them to regenerate a single hair. It's just too early in the process to make any exaggerated claims. We need more time to study what we are seeing. I think we have a tendency to be too positive about something new. We must take a wait and see philosophy first."

This is one of the most honest answers I've seen from anyone about Acell and is why I think making statements about the approval of Acell for "regenerative" medicine puts a false sense of hope in the mind of the patient.




jotronic is located in VANCOUVER, BC CANADA and he is available to meet: YES
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Post reply
jotronic

Homepage

Vancouver, BC Canada,
03.12.2013, 02:41

@ Dr. Cole

to CITnews/Dr. Cole, about donor regeneration . . .

Originally Posted by Dr. Cole

For me, I don't worry as much about what someone says something might do. I am more concerned about what it will do. What good is it for something like intercytex, or Aderans, or Histogen to say they do something? What matters more is what it does.


I agree Dr. Cole but you know just as well as I do that what we say on the forums is latched onto by patients and they don't forget. Dr. Cole said this or Dr. So & So said that so it must be true, right? When Chuck is telling people that Acell is approved by the FDA for regenerative medicine people start to believe that the regenerative properties are a sure thing. The FDA approved it so it must be true.

Btw, it was nice to finally shake your hand in San Francisco and congratulations on winning the Golden Follicle Award.




jotronic is located in VANCOUVER, BC CANADA and he is available to meet: YES
email hairsite@aol.com to arrange a meeting.

---
[image]
www.HassonandWong.com

All opinions are my own and may not necessarily be shared by Dr. Wong and/or Dr. Hasson.

If you are interested in having an online consultation visit www.hassonandwong.ca


Post reply
licht

03.12.2013, 06:07

@ CITNews

Not true. . .

Originally Posted by licht


IMO, It appears to me that what you claim is "false" is a legalistic stretch and I also didn't state that the FDA's "rubber stamp" is illegitimate at all. I just stated that a government agencies declaration or evaluation isn't ALWAYS reliable. That was the purpose of my previous post. And yes it is VERY relevant. Obviously not to you because it doesn't support your tedious arguments.


This is nothing but misdirection, in the worst possible sense.

Let's just restate the few basic tenets of the issue:

1) You stated that the FDA has approved ACell as a medical product

2) FDA approval for any particular indication means the FDA agrees that effectiveness and safety has been demonstrated to an appropriate degree.

3) This means that the "rubber stamp" (as you call it) of FDA approval can for good reason give the public a sense of assurance that the product's safety and effectiveness has been shown to a high degree of satisfaction.

4) The distinction between approval and clearance is NOT legalese. It implies a very different set of standards

5) Even aside from that very significant distinction between approval and clearance, ACell has not even been cleared for use as a regenerative medical product. The word regeneration is not used at all in the FDA's notification of clearance, or in the application. In other words, the FDA has made no statement whatsoever on use of ACell as a regenerative product. Even if for some reason you incorrectly feel that approval and clearance imply the same thing, which they do not, ACell's clearance makes no mention at all of its use as a regenerative medical product.

5) Whether or not you consider the FDA's stamp important or not is immaterial. If you don't consider it meaningful, then don't use it. If you do consider it meaningful, then use it accurately. More importantly, the public does consider it meaningful, and it gives people a sense of confidence that the product has been tested to the FDA's stringent standards.

5) Falsely claiming that a product has FDA approval for an indication that it does not is very serious. It wrongly gives the public the sense that FDA has verified that the product has efficacy in that area, when in fact in this case the FDA has not even considered it.

6) This is made all the more serious when coming from the representative of a clinic using that product.




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Post reply
CITNews

Alpharetta,
03.12.2013, 16:09

@ licht

Not true. . .

The main mission of the FDA is to protect the population and clear products for sale. The FDA requires the approval process when it considers a product could pose potential danger to health, safety, and life.

FDA approval does not mean FDA product brand endorsement as some people interpret or imply. It basically means that they considered a product potentially dangerous until the manufacturer proved to them otherwise.

ACell is a regulatory Class II device. It could not be sold if it did not have FDA clearance or approval. The FDA either clears a product for sale or it doesn't. ACell is a product sold legally to physicians in the United States.

The FDA apparently agrees with a paper published on their Website that does speak favorably of regenerative medicine which includes extracellular matrix products. ACell is of course a brand of extracellular matrix.

Here are some quotes from the article on the FDA Website that speaks favorably and optimistically of regenerative therapies:

"Ensuring Safety and Efficacy of Stem Cell-based Products
Principal Investigator: Steven R. Bauer, PhD
Office / Division / Lab: OCTGT / DCGT / CTTB"

"General Overview
Cell-based therapies show great promise for repairing, replacing, restoring, or regenerating damaged cells, tissues and organs. Researchers are working to develop cell-based treatments that are both effective and safe."

"Scientific Overview"
"Part of the microenvironment is the extracellular matrix made up of a carbohydrate-protein gel. The extracellular matrix helps to support the cell and cushion it from physical stress; it also serves as a means through which cells communicate with each other by releasing signaling molecules.

The communication among cells, as well as the time and conditions in which cells grow exert significant influence on stem or progenitor cell proliferation and differentiation. Progenitor cells are stem cells that have differentiated enough to be committed to becoming a certain general type of cell, and will eventually differentiate into a specific cell."


Look at it this way, if a tobacco scientist requested that a study he conducted be published on the FDA Website promoting the idea that cigarette smoking cures cancer, the FDA would of course turn him down. Of course this is an extreme example but I believe that if the FDA didn't agree with any statements made in the article linked above by Steven R. Bauer, PhD they would have required Steven to edit them out. So essentially, one could say the FDA approves of ACell mirroring those statements on their own Website made by Steven R. Bauer, PhD.

Today a doctor who trained with Dr. Cole in the art of FUE surgery using Cole Instruments, is having Dr. Cole perform his hair transplant. While he was in my office today, he told me that when he was at the ISHRS meeting in San Francisco, he met with representatives from ACell. He said they flatly refused to even make a statement regarding the use of ACell in hair restoration surgery, so yes, ACell is very careful about what they say.

Here is a quote from their Website:
"About ACell
ACell, Inc. offers the next generation of regenerative medicine through the development and commercialization of unique extracellular matrix (ECM) medical devices to repair and remodel damaged tissues in a broad range of applications. ACell’s patented ECM medical devices address important clinical needs, while providing safe, effective, economical and therapeutic outcomes to the wound care and surgical communities. These medical devices, trademarked as MatriStem, are appropriate for acute wounds, chronic wounds and various surgical procedures. All MatriStem devices are made in the USA. For more information, call (800) 826-2926 or visit www.acell.com."

CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice




CITNews is located in ALPHARETTA and he is available to meet: NO

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Post reply
NeverAgain

03.12.2013, 17:21

@ licht

Not true. . .

Originally Posted by licht



5) Falsely claiming that a product has FDA approval for an indication that it does not is very serious. It wrongly gives the public the sense that FDA has verified that the product has efficacy in that area, when in fact in this case the FDA has not even considered it.



I agree. Approved or cleared is not important, the most important is "indication of use".

A good example of FDA cleared device for the treatment of certain types of hair loss,
http://lasercomb.net/index.php?option=com_content&view=article&id=55&Itemid=63




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Post reply
licht

03.12.2013, 17:29

@ CITNews

Not true. . .

Originally Posted by CITNews

FDA approval does not mean FDA product brand endorsement as some people interpret or imply. It basically means that they considered a product potentially dangerous until the manufacturer proved to them otherwise.


This is, again, just more misdirection.

Nobody has suggested that FDA approval implies some sort of "product brand endorsement". It does however mean that a successful applicant has demonstrated to the FDA that the product is reasonably effective for a particular indication, something very valuable for consumers to know.

ACell, as a product cleared through 501k, does not need to do that, and has not done that. It is not FDA approved. Moreover, it is not indicated by the FDA as a "regenerative medical product" at all, even in its 501k clearance.

The FDA simply does not approve (or has not even cleared) ACell as a "regenerative medical product" in any way, shape or form. This doesn't mean that it isn't efficacious in that respect, or that ACell cannot suggest that it might be. It means that it is not FDA approved for that indication, and that neither they nor you can say that they are. Note that ACell does not make this claim. You do.


ACell is a regulatory Class II device. It could not be sold if it did not have FDA clearance or approval. The FDA either clears a product for sale or it doesn't. ACell is a product sold legally to physicians in the United States.


First, ACell, as a Class II device, cannot be sold without FDA clearance. It does not, however, require FDA approval to be sold. The FDA is very clear about the difference between the two.

Nobody is suggesting that it is not being sold legally to physicians.

The FDA apparently agrees with a paper published on their Website that does speak favorably of regenerative medicine which includes extracellular matrix products. ACell is of course a brand of extracellular matrix.


You cannot be serious. Broad statements that the FDA makes that are optimistic about regenerative therapy and or extracellular matrices are not in the slightest an indication that the FDA has approved ACell as a regenerative product (or that it has approved ACell at all). The article in question doesn't even mention ACell.

Simply put, FDA approval is a yes or no thing. Either ACell is FDA approved for a certain indication, or it isn't. ACell is not approved as a regenerative medical product. Trying to confuse the issue by posting totally irrelevant articles on extracellular matrices won't change that.

So essentially, one could say the FDA approves of ACell mirroring those statements on their own Website made by Steven R. Bauer, PhD.


What? FDA approval is an official status that a drug or device receives for a particular indication after undergoing a well-defined approval process. The vague notion that the FDA might agree or disagree with statements the company, or be optimistic about the company's industry or area of research makes makes absolutely no difference, and certainly does not equate FDA approval.

Today a doctor who trained with Dr. Cole in the art of FUE surgery using Cole Instruments, is having Dr. Cole perform his hair transplant. While he was in my office today, he told me that when he was at the ISHRS meeting in San Francisco, he met with representatives from ACell. He said they flatly refused to even make a statement regarding the use of ACell in hair restoration surgery, so yes, ACell is very careful about what they say.

Here is a quote from their Website:
"About ACell
ACell, Inc. offers the next generation of regenerative medicine through the development and commercialization of unique extracellular matrix (ECM) medical devices to repair and remodel damaged tissues in a broad range of applications. ACell’s patented ECM medical devices address important clinical needs, while providing safe, effective, economical and therapeutic outcomes to the wound care and surgical communities. These medical devices, trademarked as MatriStem, are appropriate for acute wounds, chronic wounds and various surgical procedures. "


ACell isn't the one saying they are FDA approved as a regenerative medical product. You are. We are not saying that ACell is being misleading. We are saying that you are. The fact that ACell uses the word "regenerative medicine" on their website doesn't mean or imply in any way that they are FDA approved for that indication, nor does it mean that they are implying they are. You however, stated that outright, and that is quite simply wrong.




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Post reply
CITNews

Alpharetta,
03.12.2013, 18:45

@ licht

Not true. . .

The FDA will sometimes endorse a product. One case in point is Aspirin (acetylsalicylic acid), the FDA in my view endorses Aspirin in an article on their Website because of its proven effectiveness in the prevention of heart attacks.

The ACell brand of extracellular matrix is not named anywhere on the FDA Website that I'm aware of and singled out for endorsement. The way I see it relates to a common misperception of what FDA approval means. FDA approval as opposed to endorsement means that a product that was suspect of possibly being dangerous or ineffective, even in some cases to the point of death, has emerged from often intense scrutiny and given consent to be legally marketed and sold.

As Jotronic pointed our in an earlier post, the company ACell received a warning letter from the FDA back on April 26, 2013. There is NO mention in that warning letter of reprimand for marketing their product as in their own words on their Website:

"Founded in 2002 and headquartered in Columbia, Maryland, with more than 300 employees in the United States, ACell, Inc. is a leading developer, manufacturer and marketer of next-generation regenerative medicine products. Our medical devices are cleared for a variety of indications and are marketed under the brand name "MatriStem." A privately held Company, ACell produces MatriStem at our full scale manufacturing facilities in Columbia, MD and Lafayette, IN, and markets its products to physicians in the U.S. through a national direct sales force."

If the FDA disapproved of these statements all over their website and marketing material, they would have been gone by now. As I mentioned, the FDA either approves or disapproves. There are no "well maybes".

CITNews works at Dr. Cole's office
forhair.com
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com




CITNews is located in ALPHARETTA and he is available to meet: NO

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CITNews works for Dr. Cole's clinic in Atlanta
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Post reply
licht

03.12.2013, 19:26

@ CITNews

Not true. . .

Originally Posted by CITNews

The FDA will sometimes endorse a product. One case in point is Aspirin (acetylsalicylic acid), the FDA in my view endorses Aspirin in an article on their Website because of its proven effectiveness in the prevention of heart attacks.


Irrelevant to the discussion. We are not talking about some vague, ill-defined endorsement. FDA approval is, again, an official status which a drug or device either has or does not for any particular indication. ACell DOES NOT HAVE any sort of approval whatsoever as a "regenerative medical product". This is simple fact.


The ACell brand of extracellular matrix is not named anywhere on the FDA Website that I'm aware of and singled out for endorsement. The way I see it relates to a common misperception of what FDA approval means. FDA approval as opposed to endorsement means that a product that was suspect of possibly being dangerous or ineffective, even in some cases to the point of death, has emerged from often intense scrutiny and given consent to be legally marketed and sold.


Wrong. Every drug or medical device that is either cleared or approved is mentioned on the FDA website, including ACell's MatriStem. ACell's clearance under 501k is right here: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092926.pdf. It clearly states exactly what ACell is cleared for, and what predicate device this clearance was based on.

If a device or drug is approved or cleared by the FDA for a particular indication, it will say so on this website. This is, again, an official status, and a very important distinction.


As Jotronic pointed our in an earlier post, the company ACell received a warning letter from the FDA back on April 26, 2013. There is NO mention in that warning letter of reprimand for marketing their product as in their own words on their Website:


Once again, totally irrelevant misdirection. That the FDA hasn't explicitly said that ACell cannot use the word "regeneration" in its marketing does not mean that ACell's MatriStem has FDA approval for that purpose. That you try to make this leap indicates that your understanding of what FDA approval is is rather vague. More to the point, you should note that ACell does NOT claim to be FDA approved as a "regenerative medical product". Only you claimed that.


If the FDA disapproved of these statements all over their website and marketing material, they would have been gone by now. As I mentioned, the FDA either approves or disapproves. There are no "well maybes".


You seem to not really understand what FDA approval is. It's an official status that results from a drug or device successfully completing a regulatory pathway. It must be EXPLICITLY given. If you want to know if the FDA has approved or cleared a particular product, you can look it up in their database.

You are, however, correct in that there are certainly no "well maybes". A product is either a product is approved for an indication or not. MatriStem is NOT approved as a regenerative medical. No "well maybes" at all.




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