To CITnews/Dr. Cole, about donor regeneration

Hair Transplant
41

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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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.

43

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.

44

[quote][postedby]Originally Posted by robohair[/postedby]
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. [/quote]

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.

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.

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 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.

45

[quote][postedby]Originally Posted by Dr. Cole[/postedby]
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.[/quote]

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.

46

[quote][postedby]Originally Posted by licht[/postedby]

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.
[/quote]

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.

  6. 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.

  7. 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.

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

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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

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

48

[quote][postedby]Originally Posted by licht[/postedby]

  1. 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.

[/quote]

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

49

[quote][postedby]Originally Posted by CITNews[/postedby]
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.
[/quote]

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.

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.

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.

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

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.

[quote]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. "
[/quote]

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.

50

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

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

51

[quote][postedby]Originally Posted by CITNews[/postedby]
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.
[/quote]

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.

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.

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.

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.

52

No company is going to spend exorbitant amounts of money for the privilege of having any government agency declare their product worthy or great. Companies spend the big money so they can legally sell their products. Call it clearance call it approval. It’s really about the legal privilege of selling a product. If anything, in my view, “Approval” in the context of the official FDA approval process, detracts from a products prestige. Products required to go the approval process have been evaluated as possibly being unsafe or ineffective. Companies have to prove otherwise, often at great expense in order to sell such products.

Patients care about the effectiveness of products far more than words.

CITNews works at Dr. Cole’s office

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

53

Examine the news.

CITNews works at Dr. Cole’s office

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

54

A great example of the importance of the FDA Approval process regarding certain devices or drugs is the story of Thalidomide. Roughly 51 years ago, the FDA prevented a major public health disaster by ensuring that the sedative thalidomide was never approved in the United States. As some may remember, in the early 1960’s, reports were coming in from outside the US of countless women who were giving birth to children with extremely deformed limbs and other major birth defects. They had taken Thalidomide. Although it was being used in many countries, Dr. Kelsey with the FDA uncovered the fact that Thalidomide had never been tested on pregnant animals.

So in my opinion, the FDA is doing a great service to the public by rigorously testing products where there is uncertainty regarding its safety or effectiveness.

The bottom line here is the FDA prevented a dangerous drug from being marketed and sold to the public.

CITNews works at Dr. Cole’s office

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

55

[quote]
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. [/quote]

so does it mean that doctors are not allowed to use Acell to treat hair loss or is this a gray area? That’s all I want to know.

56

[quote][postedby]Originally Posted by CITNews[/postedby]
selling a product. If anything, in my view, “Approval” in the context of the official FDA approval process, detracts from a products prestige. Products required to go the approval process have been evaluated as possibly being unsafe or ineffective. Companies have to prove otherwise, often at great expense in order to sell such products.
[/quote]

Absolutely nothing you’re saying here addresses the issue at hand, that ACell is not approved by the FDA for the indication you claimed it was. In fact, the FDA hasn’t looked at ACell’s product for that indication at all.

If you think that a product being FDA approved for an indication somehow lowers its “prestige” (something totally bizarre for a clinic rep to say), then fine. Just don’t claim that something is FDA approved when it isn’t. It may not matter to you for some reason, but it matters to patients, it matters to doctors, it matters to the FDA, and it matters to the people here who read what you write and may not know better. You posted a falsehood.

So that somehow means that the accuracy of the words you use while representing your clinic on a public forum don’t matter? If you are pleased with the effectiveness of the product, feel free to say so. Even better, demonstrate it to us, when you are ready, with clinical evidence. However, don’t mislead about its FDA status.

57

[quote]

[postedby]Originally Posted by reiner[/postedby]

so does it mean that doctors are not allowed to use Acell to treat hair loss or is this a gray area? That’s all I want to know.[/quote]

I believe that doctors are allowed to use ACell “off label”, as long as they don’t mislead their patients about the potential results, or about the product’s FDA status concerning what they are doing.

I don’t have any reason to believe that, aside from, CITNews, Dr. Cole’s clinic is doing anything wrong. I doubt that Dr. Cole, for example, is misleading his patient’s about ACell’s FDA status, or about what he believes it can do, and it’s great that clinics are experimenting honestly with this sort of stuff.

58

Our ACell order just came in. Does that say something about healing through regenerative medicine? The FDA must have missed that. It is pretty hard to see!!! ACell also has the term “regenerative medicine” repeated 18 times on their Website’s news page!

17440_image67.jpg700×525 51.1 KB

CITNews works at Dr. Cole’s office

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

59

[quote]

[postedby]Originally Posted by reiner[/postedby]

so does it mean that doctors are not allowed to use Acell to treat hair loss or is this a gray area? That’s all I want to know.[/quote]

Hair restoration doctors are permitted to use ACell during and after hair restoration surgery. We use ACell mixed with PRP as a stand-alone procedure as well.

CITNews works at Dr. Cole’s office

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

60

You seem to treat this issue like a joke. Absolutely astonishing. It reflects horribly on your clinic.