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Requirements for validity of ALL patch tests


#1

Dr. Nigam and all,

Many people have long been proposing various “patch tests” to measure the effectiveness of different experimental HM and HT pricedures.

While I a agree with the concept of patch tests, we should be very careful about using them. Patch tests should scrupulously adhere to established scientific control methods.

I think all researchers, and experimental patients, ought to adopt the following three rules for ALL patch tests and similar experiments:

(1) The experimental field should be as bald as possible on a particular patient. Doing a patch test on a scalp area that already has a lot of growing terminal hairs totally defeats the purpose, because it becomes very difficult to determine which hairs are “new” (i.e., the result of the procedure) and which hairs are simply native to the field, either already growing terminal hairs or terminal hairs which have just returned to the telogen stage. Using the baldest scalp area possible establishes a clear and indisputable baseline against which to measure the result.

(2) Only ONE experimental procedure should be performed in any one patch test area before establishing the result. There should be no combinations of “in vivo plus doubling”, “HM plus growth factors”, “FUE plus stem cell injections”, or anything like that. We still do not know much about the real potential of most of these experimental procedures. To combine them for the purposes of experimentation only muddies the waters, and guarantees that we will still not know much or learn anything clear. We need to measure and gauge the efficacy of each procedure SEPARATELY.

(3) Likewise and for the same reason as (2) above, patients who undergo experimental patch tests should not be on any regimen of hair-growth medications such as Minoxidil, Finasteride, PGD2 blockers, or anything else like that, for a reasonable period before and after the procedure is performed and results are measured.

In short, to perform experimental “patch tests” in any way other than the above should not be acceptable because it would not follow the scientific method, or logic.


#2

I am sure these are things that Dr. Nigam and other doctors are fully aware of way before they conducted their tests however whether they want to follow through with your recommendations is a different story.


#3

[quote][postedby]
(2) Only ONE experimental procedure should be performed in any one patch test area before establishing the result. There should be no combinations of “in vivo plus doubling”, “HM plus growth factors”, “FUE plus stem cell injections”, or anything like that. We still do not know much about the real potential of most of these experimental procedures. To combine them for the purposes of experimentation only muddies the waters, and guarantees that we will still not know much or learn anything clear. We need to measure and gauge the efficacy of each procedure SEPARATELY.
[/quote]

This would certainly be sound experimental procedure.

However we are at a point where we don’t even know what works. I do think
Nigam’s approach of throwing in everything and the bathroom sink in hopes that
some combination will work is the only way forward for now.

Once some combination is found to work (which would be a miracle), it can
then be deconstructed part by part using the above process to see what
exactly is making it work.


#4

[quote]This would certainly be sound experimental procedure.

However we are at a point where we don’t even know what works. I do think
Nigam’s approach of throwing in everything and the bathroom sink in hopes that
some combination will work is the only way forward for now.

Once some combination is found to work (which would be a miracle), it can
then be deconstructed part by part using the above process to see what
exactly is making it work.[/quote]

I do see your point in throwing everything at the wall, but it turns out this is sloppy experimental technique, costs patients a lot, and you end up having to backtrack, and, as you said, deconstruct the whole thing piece by piece to determine what is really happening. It ends up taking just as much time, if not more time, to do it that way. I think that since we still know very little about the potential of these procedures, the wisest approach is a more meticulous one, of trying each procedure individually.

By taking a structured, meticulous approach, there would be no question of false positives, mixed-up and muddled results, over-hype, confusing and misleading claims by researchers, hysteria and spin on internet forums and false alarms and excitement which is unwarranted.

We would get to see the REAL potential of each procedure individually and separately and make our own conclusions, based on seeing a succession of patients who have had each procedure performed on “tabula rasa” bald areas.

Then, once a baseline efficacy for each procedure is established, different procedures could be combined to augment results.

Here’s what I think would happen, and actually is happening right now, with the muddled approach you prefer.

Let’s say that a doctor conducts a so-called “experiment” on a patient, and uses experimental techniques A, B, and C on the patient. Let’s say that after 6 months, there is good, decent, visible hair growth documented by photos.

Let’s say that the REAL reason for the hair growth was ONLY procedure B, and procedures A and C had no effect whatsoever. Let’s further assume that procedure B is very hard to do, and only this particular doctor has successfully devised it, perfected it and mastered it to a reasonable degree. Procedures A and C are very easy to do, can be easily implemented by HT doctors around the world, are cheap office procedures for which the doctors can charge a HUGE price markup compared with their actual costs. Thus, procedures A and C are VERY APPEALING to HT surgeons who want to get a lot of patients in the door and maximize profits… which is most of them. But procedures A and C are completely useless.

If we take your “bathroom sink” approach, then doctors around the world will immediately see these results, and start offering procedures A and C to patients. In fact, they will base their claims on the hype and buzz generated by the initial experimental results from A, B and C, as circulated on the internet. They will leverage and take advantage of this buzz, fully knowing that they DO NOT REALLY KNOW the true potential of any of these procedures, because they have not performed, witnessed or studied any scientifically valid controlled testing themselves. They probably will not offer procedure B, because it costs them far too much to do and they don’t have the technical expertise to do it; moreover they don’t want to invest the time, effort and money to learn and ramp up for such a procedure. They’d rather just offer A and C and watch the money flow in.

Now, in that scenario, which I think would be the unintended but very real (and very common) outcome of your idea, all these doctors around the world who are now aggressively marketing and pushing these two useless procedures A and C (based on the initial experimental results I described above, using A, B and C), would make a lot of money, while perpetuating complete nonsense.

The upshot is that we still don’t know any more DEFINITIVE information than we did before, but lots of people around the world are getting sc@mmed.

This WOULD be the result of what you propose. In fact, I think it is already happening right now, on a huge scale, with many hyped “procedures”. I think PRP is one of these, but there are numerous others.

Like I said, I do see your point and understand it. That approach appeals especially to impatient people who want to see hair NOW. I just think that at the end of the day, the framework I’ve spelled out is a bit better for the hairloss community as a whole.


#5

With due respect to Rogerthat, I think 2/3 procedures like invitro,invivo,de novo can be combined in a single patient, particularly in Dr.Nigam’s case where potentially cancer inducing agents are going to be used (and fewer test subjects will come foward) - Provided that each procedure on the scalp is well marked out by tatoos.
I also do not think a slick bald scalp is a must (for recipient area).The recipient area can be a thinning area where the hairs are thin in diameter.The transplanted hairs are going to be thick (being from back of scalp).Macro photography should,i think, easily show the transplanted hairs (from the existing thin diameter hairs).
Problem would be the donor area where the lower part of the follicle is transplanted in the same donor area.

cell based injections(like what Dr.Nigam is doing) + other combinations should be on a separate scalp.


#6

[quote][postedby]Originally Posted by bmaamba[/postedby]
With due respect to Rogerthat, I think 2/3 procedures like invitro,invivo,de novo can be combined in a single patient, particularly in Dr.Nigam’s case where potentially cancer inducing agents are going to be used (and fewer test subjects will come foward) [/quote]

OK, if this is what you wish, then go ahead and do it. I don’t see what the fact that he’s using potential cancer inducing agents (things like VEGF, KGF, and Wnt promoters) has to do with performing multiple treatments concurrently on one patient. You think fewer test subjects will come forward? Have we seen any evidence of that? Most potential patients don’t even know what these compounds are. I have seen no lack of enthusiasm for using any of these agents here on this forum, by self-experimenters, or people trying to obtain such treatments from doctors or through the internet. Histogen uses those agents, and there is a huge amount of enthusiasm and interest about Histogen’s HTC, in fact Histogen itself says nothing about potential for cancer induction.

It’s really funny how memes spread on the internet because a year ago, I was one of the only people seriously talking about the risk of cancer from these substances, while everyone else who was discussing them seemed to be gung-ho for using these compounds, and screw any risk.

Now, I guess my meme about cancer risk has circled back around, through discussions on other forums, and here I am saying that tests with tissue growth factors shouldn’t pose any problems, while other people are talking about cancer.

What I really mean is, of course, the risk can be contained to the negligible zone if they’re used very carefully and in small amounts. I think they may be useful to activate native HF stem cells, and for that, you probably only need very small amounts – the activated stem cells will do the rest of the work. I wouldn’t recommend regularly engulfing your scalp in these compounds!

Note: technically, VEGF isn’t really a cancer “inducer” anyway. It’s more of a cancer promoter. VEGF induces growth of new vascular endothelium, i.e., angiogenesis especially of new small blood vessels. When there is a preexisting cancer, it can promote the much faster growth of such a cancer, by causing new blood vessels to grow which supply the tumor, which is very dangerous. But I don’t believe there’s any evidence at all that VEGF can cause a de novo cancer.

On the other hand, cancer worries may be more realistic with all that Wnt-promoting stuff. Most likely, the cancer risk would increase with the amount and frequency of exposure. So some caution is definitely required.

Well, of course. When I criticized multiple concurrent treatments on a single patient, I was referring to the use of multiple treatments concurrently on a single AREA of the scalp, i.e. on the same exact location.

Obviously if separate portions of the scalp are going to be carefully cordoned off using tattoos, and only a single treatment is going to be used on each individual area, then of course the problems I talked about wouldn’t apply. It has to be done carefully. But so far, I have not heard of Dr. Nigam or any other doctor seriously talk about this kind of test – where a single patient has multiple procedures performed concurrently on different, carefully marked-off portions of the scalp. Have you discussed this with Dr. Nigam?

I didn’t say it was a must, but just greatly preferable. You’re right, the area can just be a thin area. Obviously, if a patient has no slick bald areas on his scalp, then using the thinnest possible areas would be preferable. If no areas are very thin, then of course, this doesn’t apply. I’m just saying that for the purposes of experiments, patch tests, etc., using the baldest possible area is best, because it would provide the most illustrative results, clear evidence for everyone that the procedure works or it does not.

Not necessarily. That kind of generalization isn’t useful. You can have any possible combination of donor and recipient hairs. Recipient area hair may be sparse, but the individual hairs may be thick (like mine). Donor hair doesn’t necessarily have to be thick, either while growing in the donor area or after the cell injections grow in the recipient area. Even cells taken from thick donor hair (where the hairs are individually thick) won’t necessarily yield thick hairs in the recipient area. EVERY SINGLE COMBINATION is possible, because each person’s genetics and potential as a responder is a bit different.


#7

I have not discussed anything more with Dr.Nigam.As Dr.Nigam has not responded after my posts in the other thread, I do not know if Dr. is still interested in me as a test subject.
Any thing you guys (consensus) in the forum decide ( and want me to do), I am ready to be a test subject- provided someone else does the photography and i am not asked to stop taking Saw palmetto and also not asked to stop putting v. light amount of coconut oil on the scalp.
Disclosure -I also may be suffering from lichen planoparis at the whorl(2-3 sq.mm).Every 7-10 days or so, i feel like removing (with my nails) a crusty/scaly skin near the whorl.