Thank you for your question.
You've submitted a question where you're describing your situation as having had thin hair since
you were young.
And that you are describing a scenario where you've been losing hair, and particularly
associated with dieting.
And in addition, you have described some possible therapeutic options and it included topical
minoxidil, ACell plus PRP, as well as the – but in particular the use of ACell and
PRP in the absence of having a hair transplant.
And you've expressed a concern about FDA approval.
Well I can certainly help you with this question.
I’m a board certified cosmetic surgeon, practicing in Manhattan and Long Island for
over 20 years.
I've been performing hair transplant for this time frame as well as being the founder of
TrichoStem Hair Regeneration Center.
In which I use ACell and PRP in a very specific way that I developed in our practice over
several years as a non-surgical alternative to hair transplant, as well as a treatment
that supports hair transplant when appropriate.
So this is – like certainly an important question to resolve.
So let’s begin with this very common confusion about the FDA’s role in medical practice.
The FDA in the United States regulates drugs and devices.
The FDA allows the use of certain drugs and devices through rigorous proof and testing
of safety and other things.
But the FDA does not regulate medical practice.
In fact, the FDA allows the physician the authority and does not interfere with that
authority to do their best treatment for their patient.
In fact, in the FDA Modernization Act of 1997, the FDA is actually prohibited from interfering
with a physician’s ability to treat their patients.
In many ways, the misinterpretation comes from a term called off-label use.
When people – you hear the word the term off-label use, they – it is often misinterpreted
as experimental.
It doesn’t mean that.
It actually means that once a drug or device is approved for its use on people in the United
States, doctors have the flexibility without having to disclose to patients what the drug
or device is FDA approved for.
So I’ll give you a very common drug that everyone knows called Botox.
Botox got FDA approval for the cosmetic indication for one area, and that area is in the glabella
or the number 11 lines.
That’s one area where it’s FDA-approved.
When the reality is, we use Botox everywhere.
We use it for crow’s feet lines, forehead lines.
We use it for smile lines, we use it for under arm sweating.
We use it for a lot of indications because as physicians we have the authority to use
a drug or device to help our patients.
And it isn’t considered experimental.
Certainly the reality of the practicalities of getting FDA approval for every indication
is actually just not possible to be done when you think of the wide spectrum of applications
for any given drug or device.
FDA approval gives a certain permission to a level but in no way does it affect how a
doctor uses a drug or device.
ACell is a wound-healing material and it has been FDA approved for human use since 2008.
It is used commonly in general surgery.
It is used in gynecologic surgery.
I use it in my practice for cosmetic and reconstructive procedures.
So there’s a lot of different ways to use this material.
So it is completely reasonable for a physician to use ACell for hair loss treatment.
So this is where physicians often misuse that term FDA approval, whether it’s for ACell,
whether it’s for PRP.
I have dealt with some very ignorant physicians, plastic surgeons in particular, who don’t
understand this and yet use that term irresponsibly.
And our responsibility as doctors is to inform patients appropriately and not use terms inappropriately.
I think there is almost an opportunity for legal continuing education to help doctors
understand this.
So once again if you are considering ACell plus PRP, don’t let the absence of an official
FDA approval for this use getting your way.
Now that being said, in our practice, we have been using ACell and PRP in what we call hair
regeneration and for our company, TrichoStem Hair Regeneration, where we are using this
material very effectively for pattern hair loss, for both men and for women.
And typically, we do a one treatment and for people with more advanced hair loss, we can
do a second treatment based on an individual’s response.
And this is where it gets a little bit tricky and this is why it might not be so commonly
used is that we really have to work hard to develop an algorithm based on experience on
hundreds and hundreds of patients for several years to the point where we can say that we
have enough data and volume to show that the results are sustainable for at least three
to five years.
Now it is also in contrast to hair transplant considerably more sustainable because it’s
not surgery.
The donor area in hair transplant is limited and it doesn’t stop the progression of hair
loss.
In our facility in our practice, we are using this treatment as a long term solution which
if someone needs another injection is something that can be done.
So it’s very sustainable.
The key is for – it’s just proper diagnosis.
It is very important that what you are experiencing is pattern hair loss.
We have used this treatment for other medical conditions but consistently, with 99 percent
of men responding and more than 90 percent of women responding, we know how to treat
pattern hair loss as long as hair is still present.
Basically the bottom line is, if your hair is thinning and it’s a genetic pattern-based
issue, then you can consider ACell and PRP or as what we use in our terminology, hair
regeneration.
So I would recommend you look for doctors who perform this treatment, learn more.
But – and once again, the take home message is, FDA does not regulate medical practice,
it regulates drugs and devices.
Physicians have the authority to use those drugs and devices as they see to fit for the
benefit for the patient.
So I hope that was helpful.
I wish you the best of luck.
And thank you for your question.