Getting HSC treatment now and Micropigmentation

[2020]

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

identify the problem:

http://www.jci.org/articles/view/44478

then compare that with what Histogen is doing

[2020]

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.

^ right, which is what must happen in order for this to be a "fix" like heart bypass surgery rather than just some temporary improvement like Botox.

why are they even going for three phases? Acell didn't have to do that

[gmonasco]

right, which is what must happen in order for this to be a "fix" like heart bypass surgery rather than just some temporary improvement like Botox.

Insulin is just a "temporary improvement" for diabetics rather than a permanent "fix," but that doesn't mean it's not affecting the function of the body.

why are they even going for three phases? Acell didn't have to do that

The FDA considers materials that are derived from acellular animal tissues
to be medical devices rather than drugs.

[alanrudy]

I think you misinterpreted what I was trying to say gmonasco, but I really appreciate your feedback on everything else. I realize what I said came off as more harsh than I intended on these companies like Histogen and Replicel trying to do good, I was just wondering why on the recording with Spencer he described end of 2014 as an absolute best case and possibly two years after that as likely. I wanted to try making the point that once safety has been established, that there should be no delay in offering treatments if their product really does produce results and they want to help people. They will conclude safety long before 2017 (they may even have some data/idea of that now) so that's why I was questioning if it was about money because they would have a product concluded safe and are seeing results with but are not offering it.
Depressedbyhairloss, thanks for your response, I agree with almost everything you said, especially about prp. Just a high profile case, but Kobe Bryant and Alex Rodriguez had a variant of a PRP procedure done in Germany and it basically rejuvenated his arthritic knee and now many athletics are flocking to it. That's why I said there are MANY treatments that people do that haven't been thoroughly tested nor approved by regulatory agencies, hopefully a Dr can come out with something like that German doctor did for arthritic knees for hair restoration, and hopefully it can be cost effective too. I'm not sure I agree with what you said about micropigmentation though, there seem to be at least one respected company and one can make the case it is better than propecia and rogaine. Also, I guess the example you gave with a girl could happen and a potential risk, but that accounts for a very small percentage of instances micropigmentation is not good for and even then some guy that had that same thing happen to him just told her that he shaves really close to the grain and the girl didn't even think twice about it. But just wondering if micropigmentation can interfere with Histogen/Replicel.

[gmonasco]

I was just wondering why on the recording with Spencer he described end of 2014 as an absolute best case and possibly two years after that as likely. I wanted to try making the point that once safety has been established, that there should be no delay in offering treatments if their product really does produce results and they want to help people.

Because you don't go straight from clinical testing to mass marketing, especially if you're a small biotech company like Histogen. After all the efficacy and safety issues have been worked out and all the regulatory hurdles have been cleared (events which are still quite a ways off), they have to work out how the materials are going to be produced, how they're going to be delivered to where they need to go, how the treatment is going to be administered, who is going to administer the treatment, where the capital is going to come from to create that delivery infrastructure, etc. That all takes time and money. (And Histogen may choose to sell HSC to another company rather than take that all on themselves.)

[Kiwi]

Because you don't go straight from clinical testing to mass marketing, especially if you're a small biotech company like Histogen. After all the efficacy and safety issues have been worked out and all the regulatory hurdles have been cleared (events which are still quite a ways off), they have to work out how the materials are going to be produced, how they're going to be delivered to where they need to go, how the treatment is going to be administered, who is going to administer the treatment, where the capital is going to come from to create that delivery infrastructure, etc. That all takes time and money. (And Histogen may choose to sell HSC to another company rather than take that all on themselves.)

I'm not sure I agree. Histogen is not going to spend millions of $$$ going through the FDA process without having a get to market quick plan - their investors will be like "GO GO GO"...

Where the capital is going to come from???? Are you serious???? So you invest millions in HSC. It gets approval to goto market. And then you decide to pull out and not invest the additional funds to see your investment goto market. Thats really not going to happen.

Who is going to administer HSC? Hair Transplant docs will administrer it with needles. Hair Transplant docs like Ziering are already administering it using needles to people in the trials.

Materials to make needles? They already get churned out in the billions. Not a problem.

The issues I see... mass production of the HSC itself... training the Hair Transplant Docs... but like I said... the investors would not have invested in HSC without doing Due Diligence and part of that process is "how do we get it to market"....

Rest assured the big boys have already thought about this.

[UK_]

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.

No chance.

What Histogen still need to figure out is if the process is safe and what method results in the greatest yield/outcome (if any).

Still, atleast we have a definitive date for a next release of information whatever it is, unlike some companies.

[re22]

When are they releasing new information?

[UK_]

Mid-October.

[rdawg]

Has there been any word on a 6 month result release? 6 months would be mid-july, surely they could let us know if the positive results are continuing!

[bananana]

Has there been any word on a 6 month result release? 6 months would be mid-july, surely they could let us know if the positive results are continuing!

well, mid july is now.

I agree, it would be nice for them to show some results.
I REALLY hope the news will be good.

(can't really take one more replicellike shocker. )

[Kiwi]

well, mid july is now.

I agree, it would be nice for them to show some results.
I REALLY hope the news will be good.

(can't really take one more replicellike shocker. )

Tell me about it! But unlike Replicel who were at phase 0 when everybody went insane, Histogen and Aderans (after like 5 or 6 years) are both getting close to Phase 3.

If the results were too bad the funding would have fallen through - I have high hopes for them

[UK_]

God - it's like talking to a brick wall on this forum.

REPLICEL DID NOT FAIL

[Kiwi]

But they did **** up and they lied about the time to market...