Before we assume this stuff is completely illegal in the US, we should investigate a number of clinics around the country that appear to be already offering Adipose-Derived Stem Cell treatments. For instance…
This clinic appears to be injecting the cells themselves, not the AAPE extract.
However, I would think if it’s lawful for them to inject the cells, it would be also lawful to inject fluid containing AAPE. That would just be common sense to me.
This whole question of what exactly is currently lawful and what isn’t, as far as clinical use of adult somatic (non-embryonic) stem cells, is in rapid flux in the US. The FDA has its eyes on the whole field, and it and has released a complicated mess of jumbled and confusing regulations, with respect to use of non-cultured and cultured autologous cells in clinical procedures.
Apparently, the key is if, how and for how long the cells are cultured. If the adipose-derived stem cells are simply removed from the body and NOT cultured, then I believe that is legal for doctors to do and minimally regulated (kind of like Platelet Rich Plasma). If they are cultured or induced to multiply, or biochemically manipulated, then that may not be legal according to the latest amended FDA regulations which were passed recently. Here’s a very interesting presentation about FDA regulations and guidelines on autologous cell therapies (which would include stem cell therapies)…
As far as I know, to get the AAPE extract, the cells probably have to be cultured for a while, though I’m not certain of this.
However the other thing that currently kicks ADSC’s into a higher FDA “regulatory bracket” is that they’re mainly for non-homologous use. That is, fat cells are removed from the abdomen (or some other fatty area of the body), adipose derived stem cells are removed, and those stem cells are injected – not back into the abdomen (which would be a homologous use), but somewhere else. In our case, that would be the scalp. This makes the FDA want to regulate the practice more, and in fact, that is what it does.
For non-homologous uses, a specific (and expensive, and time-consuming) application has to be made to get approval.
Anyway, this whole thing requires a lot more investigation.