US Stem Cell Inc (USRM)

[Xpecht]

Is this a drug???

Minimal manipulation...that is the question. FDA “guidelines”state that adipose is connective tissue for cushioning and support. It has been discovered that simply isolating cells from this tissue and reintroducing to their own body can have many applications with little to no rejection.

Is Isolating cells from this tissue more than “minimal manipulation”? Many would argue isolating through centrifuge is not manipulating. The FDA’s “guidelines” imply that isolation is manipulation. IMO isolating something is not Manipulation which is why I don’t think this falls under the FDA’s regulation.


Furthermore....”FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA’s guidances means that something is suggested or recommended, but not required.”

https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/ucm585403.pdf