US Stem Cell Inc (USRM)

[HFM2]

The FDA is making the case that the issue at stake here is: what are the functions of adipose stems cell in fat? In other words, while those ASCs are in the fat tissue, what are they actually doing there? This is related to the homologous use issue. If in the fat they serve a regenerative function for X or Y tissue, etc., then it would be homologous use to take them out of the fat and introduce them into another part of the body where they are already serving that regenerative function. USRM believes they are following homologous use, due to the very nature of adult stem cells, which the FDA’s attorney made it appear as though the FDA did not have a clear understanding of!

Since the stem cells in adipose (fat) tissue stay there and wait until summoned by the body to perform some repairing function, I don't see how the FDA can overcome homologous use on any form of stem cell argument, if it is simple isolation and injection.

It is clear from Chamberlain’s arguments that the FDA has a HUGE problem with importing assumed definitions into its official guidance and the CFR language. She made ts clear that 1) they are not arguing that the FDA cannot regulate SVF, only that for seven years that FDA had provided an exception that allowed USRM to provide certain therapies, so, in fact, there was no regulation due to that exception, and 2) that the problem the FDA has is that of changing definitions and interpretative inconsistency. And students/people don’t think grammar or syntax matters . . . lol!

FDA has some serious explaining to do!

FDA Code: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=1271.10