Getting HSC treatment now and Micropigmentation

[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/...ncies-in-asia/

[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.)