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The autocloned hair does not come back weaker. A simple email or phonecall to Dr. Cooley's office would confirm this. The donor grows back and the recipient grows in approx. 75% of the time. These are the facts that Dr. Cole is trying so desperately to muddy.
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I don't know why you guys are so up in arms about Dr. Cole’s post, it’s simply his point of view. It doesn't change the fact that Dr. Cooley is still experimenting with Acell and it doesn't change what Dr. Cooley believes about it’s effectiveness. Time will tell if this is the breakthrough that we have all been hoping for.Comment
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Just for instance: A comment like that …
… has absolutely NOTHING to do with “it’s simply his point of view”. Absolutely nothing!
By the way: Dr. Cole is talking here (quote/comment) about this subject:
But here I’m talking about that subject – the ISHRS called it “unprofessionally cat fight”:
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New grafts do tend to grow in finer initially, but often take on a thicker diameter as they mature. I would expect a similar course with plucked hair. We’ve had enough time to evaluate hair diameter, but like much of the material Dr. Cooley has presented, he has not taken enough time to draw any conclusions with respect to diameter, and he has not assessed diameter in a scientific manner. Dr. Cooley has not presented any evidence that plucked hairs are as coarse as the donor hair. In fact, one of the few comparison he’s made at all is the scalp plucks to the beard plucks. Here the beard plucks were much finer than traditional beard hair and as fine as the scalp hair plucks. This simply does not occur based on my considerable experience grafting beard hair. In other words, the direct comparison photographs clearly show a finer nature to plucked beard hair grafts. Measuring hair shaft diameter requires specialized equipment if you are going to get reliable results. I own it and would be more than happy to assist Dr. Cooley in a scientific study that evaluated hair shaft diameter. Thus, far, however, Dr. Cooley has presented no scientific evidence that indicates that plucked hairs typically grow in as coarse as the donor hair source. What he has done is say that plucked hairs grow in finer than FUE hair. If he wants to alter this statement, he would need to provide me with scientific evidence that supports his conclusions.
Many of the results depicted were in their infancy. If something changes in their appearance over time, I would be the first to accept this as an improvement in the technique, but there still would be a complete lack of scientific data. In the mean time, we have direct comparison of grafts obtained by FUE and grafts obtained by plucking. In Dr. Cooley’s own words, the FUE hairs were thicker than the plucked hairs. If the grafts were placed at the same time, then you would expect them to be on a similar maturation schedule. We can leave it to Dr. Cooley to follow his results and evaluate the diameters over time. He can then report them. His goal should be to measure the diameters before transplantation and then again after transplantation. I do not know if he has the equipment to perform this study in his office, but as I stated, I have it in mine.
What is missing from all these presentations is reputable science. I’ll discuss this as it relates to “autocloning”.
1. A study must include an introduction, methods, results, and a discussion. The conclusions in the discussion should be based on the results and they should answer the questions you create when you design the study. When you start the study, you must determine what you want to prove. Then you must design a method that will allow you to gather results that will support or disprove your hypothesis. Both Dr. Cooley and Dr. Hitzig skipped the methods, presented unconvincing results, and came to conclusions that were not supported by their results. Their entire effort was flawed from the beginning due to poor scientific method.
There is no direct comparison of plucked hairs treated with Acell and plucked hairs untreated with Acell in a bald crown. Therefore, not only do we have no idea whether Acell impacted the growth of viable plucked hairs, we also do not know if Acell alone impacted the growth because the grafts were predominately place in hair bearing zones. Isn’t possible that Acell alone induced growth? One must isolate variables if they want to evaluate them individually.
There is no evidence that hairs plucked from the donor area regrow in the donor area. In order to have cloning, you need to create more than one hair. Not only have the physicians failed to verify this, we have no evidence what so ever that a single hair re-grew in the donor area. Am I the only one who finds this comical? From my perspective I see the advocates eulogize their logic this way. They plucked some hair, put some Acell on it, put the pluck in the recipient area, showed them some growth, and told them it grew back in the donor area. They’ll be too trusting or too stupid to ask Dr. Cooley to show them the proof because of the physician’s reputation. Sure they’ll have to pluck 200 hairs to get 80 that grow, but who cares. Let’s toss in the word cloning and they’ll be so excited that they won’t care that they did not follow a scientific method or prove a single point they made. Bernie Madoff would have loved some guys who swallowed this stupid pill. You might still be able to invest money with Intercytex too. Even body hair works better than their potions, but some people simply become delusional when they hear the words, “hair multiplication or cloning”.
What are the methods. You can’t have a study without first defining the methods. This includes the technique you use to pluck a hair and what constitutes a viable plucked hair. How are you going to verify that a plucked hair actually regrows in both the recipient area and the donor area? How are you going to identify the plucked hair in the donor area. Suppose you have a two hair follicular unit and one hair is resting in the exodus stage. All you see is a single hair. You pluck it. You come back 3 months later and see a hair. Was that the hair you plucked or the hair that was in the exodus stage.
Other questions I’d like answered would be the yield. You can’t simply throw out a number and say, I wish I knew the specific number, but I think it is 75%. That’s not science. Furthermore, some cases might have good yields and some might have poor yields. I learned this the hard way with body hair. The same could occur with plucked hair. How many plucked hairs survive with Acell and how many survive without it. If you pluck 100 hairs, how many will regrow in the donor area and in the recipient area. How many hairs do you have to pluck in order to get 100 viable hairs. Do we need to pluck 500 hairs to get 100 that are viable plucked hairs? What happens to the non-viable plucks. What percentage of these non-viable plucks survive in the donor area? Sure we know that plucked hairs can grow back, but we also know that they do not always grow back. Why do women often need eyebrow transplants? Their plucked hairs did not always grow back! Why do people with a compulsion to pluck their hair, trichotillomania, often present for hair transplants? Their plucked hairs did not always regrow. Don’t mislead yourself. Plucked hairs do not always regrow!
Here is another example of an unscientific study that lacked methods designed to evaluate a hypothesis. With regard to scar width, Dr. Cooley presented one example of a 2 cm wide scar that resulted from another physician. The other physician excised the scar once more and it returned to a 2 cm wide scar. Then Dr. Cooley excised the scar and added Acell. The resulting scar was 6 to 7 mm at 4 months with Acell. The plan was to excise the scar again and hope for an even finer result due to the affects of Acell. My comments are as follows: An acceptable width for a strip scar is 0.5mm to 5 mm. A strip scar that is 2 cm wide is the result of poor physician technique, it is iatrogenic. Dr. Cooley feels that the reduction in the width of the scar to 6 to 7 mm in his hands was due to Acell because the original physician’s attempt at revision failed and produced another 2 cm wide scar. There are multiple factors that can affect the width of a scar revision. In 1993 I began closing my revisions in two layers. In almost all instances, the width of the scar decreased by 50% or more. With every scar revision that I’ve done, I’ve told patients that the scar may resume it’s original width, be wider, or finer. Usually they are 50% their original diameter or less. In fact, I have never revised a scar left by another physician that did not reduce in diameter though I tell every patient the scar could be the same width or wider. The point is that there are multiple factors that can affect the width of a scar other than Acell. If you don’t know the technique used by another physician, you can’t compare your technique to that of the other physician. Examination of a strip scar that was 2 cm in diameter immediately tells me that the other physician did not use excellent technique. Thus you can’t compare the two scar widths based on Acell alone. Furthermore, I can tell from the photos that the revision performed by Dr. Cooley was in multilple layers. Otherwise, the wound would have been much wider than 2 cm rather than finer when he was placing the ACell. Might the use of two layers alone have decreased the scar diameter? Of course. In addition, some physicians attempt to get additional grafts out with a revision. Perhaps rather than excising the scar alone, the original physician excised more than 2 cm and put unacceptable tension on the wound at closure. In other words, we don’t have enough information to make a determination if Acell improved this scar. Closing one side with Acell and the other without Acell using the same method of closure other than Acell would have given us an idea, but we would have required a minimum of 6 months to make the initial observation. Once again, no methods were mentioned and no comparison was performed. The methods were not designed properly to evaluate the hypothesis. We can’t evaluate this result. Never the less, Dr. Cooley drew the conclusion that Acell improved the width of the scar even though the results did not verify the conclusion. All we can do is be happy for the patient as the scar is finer. This too is an immature result, however. Scars do not begin to widen until the 3rd month usually. When they do widen, they continue widening out to the 6th month. We need to wait until at least 6 months to evaluate the results of this closure.
As an example suppose I want to reduce blood pressure. I could surmise that the sugar in the gum a patient chews is elevating blood pressure because it has more calories, elevating his weight, and increasing resistance on his vasculature. Therefore, I start my patient on sugarless gum and 6 months later we find that his blood pressure drops from 160/110 to 140/80. We then present our findings and conclude that sugarless gum lowers blood pressure because it has fewer calories. What we failed to disclose was that we also routinely put our hypertensive patients on a 1800 calorie per day diet and hire a personal trainer for each patient. Would the drop in pressure be the same without the diet and exercise? Who knows, but we certainly can’t attribute it strictly to sugarless gum once we know all the variables that were not disclosed in the study. The only way to evaluate a single variable is to isolate it and study it under a strict scientific methods. The lack of a scientific method is exactly what we find in all these examples. There are no independent variables. Without isolating the variables we cannot evaluate them.
I can go back to every example that Dr. Cooley presented and show a disconnect between the results and the conclusions based on a lack of scientific method. The presentation is interesting and nothing more. The conclusions are humorous.
In the mean time there is no evidence that autoclonging exists. If it did, I would expect Dr. Cooley to cease performing strip surgery altogether and simply pluck hair. I suspect he is a long way from that point as there are simply too many unanswered questions. The most important question is whether anything grows back in the donor area when you take an almost completely intact follicle or of the donor area. What we do with FUE is take out completely intact follicles. In the absence of Acell, they do not grow back in the donor area. In the absence Acell an almost completely intact follicle has about as much chance of regrowing in the donor area as a fully intact follicle. One question he is seeking is whether these nearly intact follicles that would have grown without Acell might not regrow the next cycle. They will follow the same cycle as a fully intact follicle most likely. I’m not sure he understands exactly what he is doing, which is transplanting nearly intact follicles. Acell might improve survival in the recipient area of nearly intact follicles, but Acell is not going to affect the life cycle of a nearly intact follicle, because it is essentialy a normal transected follicle that grew on transplantation and will continue cycling most likely. There is no magic here.
Now, wolvie, let me make something clear to you. There is no scientific data to prove a single conclusion you allude to. There is no evidence that the plucked hairs grow back at the same diameter as they were in the donor area. There is absolutely no evidence what so ever that anything similar to autoclonning occurs. Dr. Cooley performed no survival studies so there is no evidence that the survival rate is 75%. You seem to have a great deal of difficulty connecting the dots. Read my lips...Dr. Cooley presented no data what so ever to indicate that even a single viable plucked hair grew in both the donor area and the recipient area. I have no idea what your agenda is, but your conclusions are simply a leap of logic or hallucination. We all want to believe hair plucking works including myself, but no one can draw scientific conclusions based on faulty studies. Now, if you want to pull the Dr. Cooley card on me, feel free to have him give me a call or debate me on a forum. We’re not enemies or competitors. We’re colleagues who are both interested in making lives better. I welcome evidence that refutes my position simply because it will improve the possibilities for all individuals with hair loss. If it does not pan out, however, the impact on the finite donor area would be deleterious. Don’t count me to be on the bridge of that ship. In other words, show me the science.
Suffice it to say that if he is proven accurate, we are all going to stop traditional harvesting methods and start plucking hair. The aesthetic benefits are as valuable as the potential for an unlimited donor supply. There are about 100,000 hair transplants in the USA each year and the majority of them will be plucked hair. They will certainly benefit from technology that expands their donor area while minimizing scar formation. Until then, patients should proceed slowly with this technology. I think 200 plucked hair is a good number for a procedure at this time. We need conclusive science before anyone becomes more aggressive with this technology.Comment
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It's good to hear both sides of the conversation. I think we should sit back and wait for more results from Doctors Cooley and Hitzig. In addition lets see how the studies that Doctors Bernstein and Rassman are entering into go. I had a consult with Dr. Bernstein once and he seemed to be a very pragmatic individual so I'm pretty sure if he sees promise in the procedure he will say so.
Until then I will keep on my meds.Comment
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Realistically, this scenario is exactly what you want to see when it comes to medical breakthroughs: researchers who are testing out a new treatment to see if it has potential, and skeptics who are asking the tough questions about whether (and how well) that treatment is actually working.Comment
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I thank Dr Cole for his interest in our work. As I’ve stressed repeatedly, my work consists of preliminary ‘anecdotal’ observations about the use of ACell in hair restoration surgery. Of course it would be nice to have large clinical studies with control groups which would provide a higher level of proof. Any physician who has participated in formal clinical studies knows the difficulty and complexity involved in such work. These are especially difficult with hair restoration surgery, and there are almost no such studies done in our field. The bulk of what we do has developed over time based on the ‘anecdotal’ observations of forward thinking surgeons who went on to share these results with their peers.
With a product like ACell that is entirely new to our field, most physicians would be lost as to where to begin looking at possible applications within the spectrum of hair restoration procedures. Hopefully our work will provide a starting point for others to do controlled studies. I’m glad Dr. Cole is now working with ACell and is able to share his anecdotal observations with us. That is how progress occurs in our field.
In reference to “autocloning”, our work continues. As each new patient comes in for followup with positive results, I become more excited about the future of this procedure. None of our patients have complained of thinning in the areas that were plucked, and none of my test sites with plucked hair without ACell subsequently grew hair. Dr. Cole is right that occasionally Dr. Hitzig had success with plucking alone, but the fact that he saw a big difference after he began using ACell and only does it this way now is rather convincing to me that ACell is making a difference. The hair diameter certainly appears normal but I have not scientifically tested that.
In reference to the many points raised by Dr. Cole, I can sum up my answer by saying, 'time will tell'. I know he has faced similar criticisms over the years in regards to body hair transplants; nevertheless he has tenaciously carried on. That is our intention too.Comment
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Skepticism is healthy
I too thank Dr. Cole for his detailed skepticism. When analyzing his extensive report, one should not miss that he too saw impressive results with ACell in some of his body hair patients. I think Dr. Cooley's message is on target.
It is very important that ACell be used correctly to achieve optimal (and even satisfactory) results. Suspending ACell powder in saline is not optimal. One of the advantages of PRP and related mediums is that they have high concentrations of Adult Stem Cells. These are the cells that ACell, when in direct contact, converts back to the Active Progenitor Cells and are instrumental in taking over the healing process by duplication instead of scarring. ACell is unique in that it is the only ECM (Extracellular Matrix) that is Bi-Modal and incorporates the recruitment of both Epithelial and Endothelial Cells needed for skin and hair duplication. It also provides a scaffold for the process to occur which is temporary and then disappears allowing the newly recruited cells to do their work.
ACell also contains a multitude of Growth Factors as well as proteins needed to support Hair Growth-this is most likely why it has dramatically increased plucked hair survival. Plucked hairs do not grow thinner-at least not in my experience of over 10 years with them.
Let me also make it clear that my original and still use of plucked hairs has been for repair of old transplants with depleted donor areas or small areas of transplant fill-ins. It is a tedious procedure although improving as our techniques do.
My greatest fear has been the worry that judgements will be made of a discovery based on improper employment of it. Sometimes it is easier to shoot the product than the surgeon.
I applaud Dr. Cole for his intense scrutiny, but the "empirical" results, as Dr. Jerry Cooley has said, are very real and multiplying daily.Comment
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And wherefrom should he get Wnt proteins? In a supermarket?
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And wherefrom should he get Wnt proteins? In a supermarket?
http://en.wikipedia.org/wiki/Wnt_signaling_pathway
Scroll to the bottom to see the WNT proteins. I think doctors would have access to such material.Comment
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Ok. And which one should he choose and add? All availabel Wnt proteins? Or just a specific combination/mix thereof?
Concerning "Wnt proteins" - basically you're right; Dr. George Cotsarelis (Follica) brought this subject up in this field, followed by Dr. Gail Naughton (Histogen) and so on. BUT none of them ever discussed "adding" of any "Wnt proteins" to mammals for any therapeutical purpose. It's just all about "Wnt SIGNALING" and not about adding any "Wnt proteins". But feel free to read it yourself:
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EXCERPT
"79. A method for producing pigmented hair on a subject, said method comprising comprising (i) generating a hair follicle on said subject according to the method of any of claims 47-78; and (ii) suppressing an expression of a Wnt protein in said hair follicle.
80. The method of claim 79, wherein the step of suppressing an expression of a Wnt protein comprises inducing an expression of a Dkkl protein.
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So as you can see, they do not mention something of "adding" of any Wnt proteins. They just talk about "suppressing" an expression of a [specific) Wnt protein.Comment
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Wnt vs. growth factors
@Westonci – My previous post (yesterday) about the “Wnt” subject, was just a quick response out of my memory. I just read it again and checked what I wrote. But besides some grammar mistakes (I guess), everything I mentioned is basically – correct:
Dr. Gail Naughton (Histogen Inc) mentioned in this interview, that they “produce” specific types of Wnt proteins (e.g. Wnt 7a) in their own labs, as well as “other hair-regeneration-related proteins” (e.g. follistatin) under specific and controlled conditions. Thereby specific cell types (fibroblasts) INCREASE their production of specific Wnt proteins, and during the production of these Wnt proteins, the cells also “secret a variety of wound healing growth factors” (e.g. KGF, VEGF etc). All in all results in a special medium which they simply call “Hair Stimulating Complex” (HSC). That’s all – isn’t it?Nilofer Farjo, MBChB Manchester, England
Wnt signaling: a review
One of the current buzz words in the literature, in meetings, and on the Internet is “wint”; but, what exactly is wnt and how does it fit into our understanding of hair follicle physiology? And, more significantly, will it lead to a new generation of treatments for alopecia?
When we talk of “wint,” we are in fact referring to two different things: the wnt gene family and wnt proteins. Wnt genes are structurally similar genes (19 wnt genes in humans have been identified on different chromosomes) that produce signalling proteins also referred to as wnt. These signaling molecules regulate cell-to-cell interactions during embryogenesis and control normal physiological processes in adults; some of these wnt proteins are specific to certain cells and tissues.
Histogen Inc. has been conducting studies using the concepts of increasing wnt signaling to promote hair growth in clinical trials. Below I interview their founder and CEO, Dr. Gail Naughton, on these recently completed trials.
Source: Hair Transplant Forum International, Jul/Aug 2009, page 120
Concerning “abnormalities in Wnt signaling” or formations of tumors/cancer, particularly related to Wnt 5a proteins, Dr. Gail Naugthon mentioned in this interview, that they have to adapt the growth conditions to down-regulate Wnt 5a proteins and to up-regulate Wnt 7a proteins and so on.
So I ask you once again: Which Wnt protein type should Dr. Jerry Cooley “add” to the mix of Acell/PRP, and finally, for what reason? Wnt 7a proteins? Down-regulated proteins or up-regulated proteins? How much should they be “up-regulated”? Is it possible that too much “up-regulated” Wnt 7a proteins “signal” other proteins in your body to be e.g. Wnt 5a proteins or to be any other (“risky”) protein type, simply with the intention “just for fun”?
How about just adding of the mentioned “growth factors” ?Comment
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Role of WNT
Westonci and HairRobinHood
Thank you for the lively discussion of WNT. Doubtlessly the WNT pathway is critical in the formation of hair follicles. In fact, I wouldn't be surprised if the WNT pathway is activated when ACell coated plucked hair is implanted in the skin. However, I would be very cautious about adding exogenous WNT proteins as this may disturb the delicate balance of stimulatory/inhibitory factors present in this context. For example, it is well known that activation of WNT/beta-catenin is associated with tumor formation, which is why Cotsarelis' approach is requiring such careful animal studies and will be subjected to close regulatory scrutiny. In the past, some thought that Sonic Hedgehog stimulation had potential for hair loss treatment, but I believe that tumor formation occurred which shut down any further work on this. It may be that the Histogen approach, which uses a mix of embryonic proteins secreted by neonatal fibroblasts, is more desirable because that stimulatory/inhibitory system is already built in.
Regardless, use of either approach would require FDA supervised studies and should not be done by the surgeon at this time just to 'see what happens'. ACell is already FDA approved for wound healing and can be safely used as an adjunct to transplanting plucked hairs.
Thanks again for the thought provoking discussion.Comment
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