Getting HSC treatment now and Micropigmentation

[alanrudy]

Hello, I was wondering if there is any chance that after safety for HSC (or replicel) has been clearly established....why they don't offer the product now or some other company offers a similar treatment now? Personally, I'm still in a position where I could potentially have more benefit with these treatments now than waiting potentially another 5 years like the interview said. Of course there could be a little added risk and I'd sign off that there is no guarantee it'd work, but there's added risk in a lot of things and people pay money for many things (PRP injections being one example) that don't have clear complete researched studies of their effectiveness. I'd rather spend my money on this than take Propecia/apply Rogaine/other hair loss treatments.
Also, I've been thinking about doing micropigmentation as well (already shave my head), are there complications with micropigmentation and these future treatments? The proponents of micropigm say no, but just thought I'd ask here to hopefully get the same answer from unbiased sources.

[gmonasco]

Hello, I was wondering if there is any chance that after safety for HSC (or replicel) has been clearly established....why they don't offer the product now or some other company offers a similar treatment now?

a) Those products aren't being offered now because their safety and efficacy have not yet been established in clinical trials.

b) Even though a product may appear safe, it still has to be approved by regulatory agencies before it can be offered for sale.

c) There are many pitfalls and few (if any) benefits for a company to publicly release a product that has not yet been proved effective.

[alanrudy]

But my point is we know a lot about their safety already and will know for sure about safety before 5 years, why do we have to wait to find out more info on exact dosage?! For many of us, the longer/more hair loss we continue to have, the worse of we may be. It seems it's just about money for these companies to wait til exact best dosage/effectiveness. There's added risk in a lot of things and people pay money for many things (PRP injections being one example) that don't have clear complete researched studies of their effectiveness. Like I mentioned, I believe in the results so far and I'd sign off that there is no guarantee it'd work and would rather pay money for this than take Propecia/apply Rogaine/other hair loss treatments.

[gmonasco]

But my point is we know a lot about their safety already and will know for sure about safety before 5 years, why do we have to wait to find out more info on exact dosage?!

You have to wait because the safety of various hair loss treatments currently in the pipeline has neither been thoroughly tested nor approved by regulatory agencies.

For many of us, the longer/more hair loss we continue to have, the worse of we may be.

And it's frustrating, but that's the way the system works: Companies don't get to put untested medical treatments out on the market just because some people are willing to assume the risk of using them.

It seems it's just about money for these companies to wait til exact best dosage/effectiveness.

That's completely contradictory If it were all about money, they'd be rushing products to market as quickly as possible -- they aren't making any money by waiting.

There's added risk in a lot of things and people pay money for many things (PRP injections being one example) that don't have clear complete researched studies of their effectiveness.

PRP is your own blood. It doesn't require regulatory approval any more than transfusions do.

Like I mentioned, I believe in the results so far and I'd sign off that there is no guarantee it'd work and would rather pay money for this than take Propecia/apply Rogaine/other hair loss treatments.

Criticizing the companies who are working on hair loss solutions for that situation is misplaced blame. They don't have a choice.

[john2399]

Gmonasco, you seem to know alot about treatments. Do you think histogen could get early release in asia?

[2020]

why the **** does Histogen have to go through all that much especially since the hair probably won't be permanent THUS this would be purely a COSMETIC PROCEDURE.... cosmetic procedures don't need all that 3 phases crap

[cleverusername]

why the **** does Histogen have to go through all that much especially since the hair probably won't be permanent THUS this would be purely a COSMETIC PROCEDURE.... cosmetic procedures don't need all that 3 phases crap

Just curious, do you happen to have a link or something that supports the idea that the hairs won't last?

[DepressedByHairLoss]

Alanrudy, I totally sympathize with your frustration and I feel the same way that you do in a lot of respects. As a lot of these companies plod slowly through exhaustive clinical trials, many of us are losing valuable years of our lives due to hair loss. I believe that there is a chance that HSC Complex may be released in certain Asian countries once safety has been established after Phases I and II. I too would rather try out something like Histogen rather than piddle around with Propecia and Rogaine. We just have laughable options for hair regrowth out there and it's very frustrating.

That being said, I really don't trust the FDA or the government worth a damn when it comes to ensuring that products are safe for public consumption. If the government was concerned about public safety, they would've regulated the hair transplant industry by now. At least companies like Replicel and Histogen are attempting to do some good, yet for about 40 years, people have been butchered, disfigured, and permanently scarred by hair transplant doctors and the government hasn't done a damn thing to police the HT industry.

You're really right about PRP and I really wish it would further experimented with a bit more. It really hasn't worked so far but I believe that the science behind it is solid, and if tweaked a little bit, could have very positive hair regrowth results. Since PRP is autologous, it doesn't require FDA approval. I really wish more autologous stem cell procedures would be experimented with for hair regrowth (like potent bone marrow stem cells for hair regrowth); I believe procedures like these have a lot of potential.

Lastly, I wouldn't do that micropigmentation at all. It's really joke in my opinion and I can't believe that places are actually offering it. Maybe micropigmentation would have it's place in covering up a hair transplant scar, but that's about it. I personally would not want a bunch of tattooed dots all over my head. What I always think is: what if you're with a woman and she decided to feel/caress your head? And instead of hair stubble, she feels nothing but skin?

[gmonasco]

Gmonasco, you seem to know alot about treatments. Do you think histogen could get early release in asia?

Depends what you mean by "early release" and "Asia." Asia is a huge place, encompassing about a dozen different countries who each have their own medical regulatory agencies. It's conceivable that at least one of them might approve HSC before the U.S. does. Pan-Asian approval is another matter.

[gmonasco]

why the **** does Histogen have to go through all that much especially since the hair probably won't be permanent THUS this would be purely a COSMETIC PROCEDURE.... cosmetic procedures don't need all that 3 phases crap

What determines whether a product is a cosmetic or a drug is its intended use, not the permanence of its effects. If the product is "intended to affect the structure or any function of the body of man or other animals," then by law it's a drug, not a cosmetic.

[NeedHairASAP]

Asia is a huge place, encompassing about a dozen different countries who each have their own medical regulatory agencies.

HUH? DUDE PLEASE EXPAND?


ASIA=CHINA/JAPAN/VIETNAM/SINGAPORE=GOODMATH= is not true?

[NeedHairASAP]

Asia is a huge place, encompassing about a dozen different countries who each have their own medical regulatory agencies.

HUH? DUDE PLEASE EXPAND?


ASIA=CHINA/JAPAN/VIETNAM/SINGAPORE=GOODMATH= is not true?

[NeedHairASAP]

Asia is a huge place, encompassing about a dozen different countries who each have their own medical regulatory agencies.

HUH? DUDE PLEASE EXPAND?


ASIA=CHINA/JAPAN/VIETNAM/SINGAPORE=GOODMATH= is not true?

[gmonasco]

That being said, I really don't trust the FDA or the government worth a damn when it comes to ensuring that products are safe for public consumption. If the government was concerned about public safety, they would've regulated the hair transplant industry by now.

The FDA regulates drugs and medical devices; they don't have the authority to regulate medical procedures and practices. That type of regulation is generally handled by individual states' medical boards and legislatures.

[gmonasco]

HUH? DUDE PLEASE EXPAND?

http://www.pacificbridgemedical.com/medical-regulatory-agencies-in-asia/