[quote][postedby]Originally Posted by jarjarbinx[/postedby]
Why can’t they weed the stuff out of the SVF that isn’t adipose derived stem cells so that there is only adipose derived stem cells in the treatment? That wouldn’t be culturing.
[postedby]Originally Posted by roger_that[/postedby]
Technically, maybe not. But I’m a bit familiar with the way federal agencies regulate things down to finer details in grey areas, and often it’s a subjective call made almost arbitrarily by a few mid-level officials. If the regulations don’t speak precisely to the situation, then they “fill in the blanks”, and usually on the more conservative, restrictive side (unless they have some kind of “understanding” with a big industry represented by powerful lobbyists.) I think the CSN people know this, and so they’re being extra careful.[/quote]
If there is a way to find out if it would be legal and technically possible?
I will call the clinic to find out what I can in the next few days when the work-week starts.
Also, it looks to me like the big issue is culturing of the cells so I think that straining everything out that isn’t adipose derived stem cells might be allowed and it might be technically possible.
Once they strain out everything except the adipose derived stem cells there probably wouldn’t be much adipose derived stem cells. But I don’t think that they would have to culture the cells because they could instead withdraw more fat tissue and get more adipose derived stem cells that way.
[quote][postedby]Originally Posted by jarjarbinx[/postedby]
Why can’t they weed the stuff out of the SVF that isn’t adipose derived stem cells so that there is only adipose derived stem cells in the treatment? That wouldn’t be culturing.
[postedby]Originally Posted by roger_that[/postedby]
Technically, maybe not. But I’m a bit familiar with the way federal agencies regulate things down to finer details in grey areas, and often it’s a subjective call made almost arbitrarily by a few mid-level officials. If the regulations don’t speak precisely to the situation, then they “fill in the blanks”, and usually on the more conservative, restrictive side (unless they have some kind of “understanding” with a big industry represented by powerful lobbyists.) I think the CSN people know this, and so they’re being extra careful.
[postedby]Originally Posted by jarjarbinx[/postedby]
If there is a way to find out if it would be legal and technically possible?
I will call the clinic to find out what I can in the next few days when the work-week starts.
Also, it looks to me like the big issue is culturing of the cells so I think that straining everything out that isn’t adipose derived stem cells might be allowed and it might be technically possible.
Once they strain out everything except the adipose derived stem cells there probably wouldn’t be much adipose derived stem cells. But I don’t think that they would have to culture the cells because they could instead withdraw more fat tissue and get more adipose derived stem cells that way.[/quote]
I don’t know about your suggestion about purifying the cells. I think that would deprive CSN of the ability to make the claim “We’re not using pure stem cells”. One of the multiple factors that would weigh into the FDA’s decision about whether or not they’re culturing or manipulating the cells outside of the body would be the question, “Are they dealing with pure stem cells?” If they are using “pure stem cells”, then that would imply – to the FDA – that the cells were being cultured or at least manipulated outside the body.
I think there’s a strong risk that if they did something like that, it would expose them to greater FDA scrutiny and FDA’s desire to prohibit it (without an IND) would kick in. Moreover, I think the company is well aware of this – consciously aware of it in this case – and that is probably why they haven’t tried something like that already, even though I’m sure they’d like to.
Remember, these regulations don’t speak to every scenario, so when a new scenario pops up, the regulators have to connect the dots and fill in the blanks, and they usually do that in a subjective way. The problem is that once they make one of these subjective decisions, they almost never want to back out of the decision and revise it, without rewriting the regulations. And rewriting regulations is usually a LONG (years), very time-consuming and complicated process. Trust me.
I am seriously thinking about these two clinics. It looks like they are advertising that they use the actual adipose derived stem cells. What do you think of these two clinics?
Have you found any clinics offering pure adipose derived stem cells or in all the world are there just these 2?
I am seriously thinking about these two clinics. It looks like they are advertising that they use the actual adipose derived stem cells. What do you think of these two clinics?
Have you found any clinics offering pure adipose derived stem cells or in all the world are there just these 2?[/quote]
A lot of questions have to be asked. First, are you talking about clinics that offer ADSC specifically for hair, or just ADSC for various medical conditions? Perhaps clinics that are already using ADSC for other reasons could be persuaded to use it for hair loss.
There’s a clinic in the Bahamas, Okyanos Heart Institute, that is using adipose derived stem cells to treat the heart:
Notice where it says, “Your own fat-derived stem cells”.
Although they specialize specifically in treating the heart, perhaps they could be persuaded to develop a hair restoration practice.
I saw a video on YouTube about a year ago about a clinic in Scotland that was offering ADSC for hair loss. I don’t know if they still are. At the time I didn’t think much of it because I had not seen the journal articles like Dr. Fukuoka’s which confirmed ADSCs could grow hair. And they may have been using SVF, for all I know.
I wonder if we organized a group to go to Switzerland to get their treatment - true and pure adipose derived stem cells - if we could get a discount? What do you think?
Roger I just sent the heart clinic an email. I may wait a few days to see if they respond to my email before I call them.
Roger, do you have any idea how long it will be until pure cultured adipose derived stem cells will be legal in the USA? It seems to me that researchers have been playing with them for years so it seems to me that they should become legal in a year or two. Researchers have been toying with adipose derived stem cells since forever it seems. What do you think?
I wonder if there are anymore FDA sanctioned studies involving adipose derived stem cells. And also if one treatment using adipose derived stem cells comes to market does that authorize all treatments involving adipose derived stem cells? For example, as soon as the FDA gives the green light for harvesting, culturing, and re-implantation of adipose derived stem cells to treat one condition it seems to me that then all the doctors treating other conditions would also be allowed to harvest, culture, and re-inject adipose derived stem cells into other parts of the body to treat other conditions. What do you think Roger?
I spoke with The Bahamas clinic on the telephone today and they said they are doing heart patients right now. They said they are not even considering doing hair loss patients yet. They also said that while The Bahamas legislation allows adipose derived stem cell therapy for heart disease The Bahamas legislation does not allow adipose derived stem cell treatment for hair loss. He also said that new legislation is coming soon to expand the number of medical condition that can be treated with adipose derived stem cells but the new legislation will take awhile to finalize and hair loss may not be one of the conditions listed.
The Bahamian clinic will not work for us for a number of other reasons but the reasons stated above are sufficient to conclude that we need to look elsewhere for adipose derived stem cell therapy.
There are no clinics in the USA offering PURE adipose derived stem cells treatments commercially. None. If you want this type of treatment you have to get it abroad.
The three clinics we should be looking at are the clinics in Switzerland, China, and Vienna.
This is an advertising site for paid
advertisers to showcase successful hair restoration results only. It is not the
mandate of this site to engage in the discussion of failed, unsuccessful
procedures, lawsuits, litigations, refunds or complaint cases. Surgical hair
restoration procedures carry risks. Please do thorough research, consult your
own physician and investigate a doctor's background carefully before making a
decision. By proceeding to use our site, you agree to abide by our Terms of Use & Privacy Policy at http://hairsite.com/terms-of-use/ where you can also find a list of HairSite's sponsoring physicians.