October 1, 2020

The Niche

Knoepfler lab stem cell blog

Polls on futures of stem cell clinics sued by FDA

i voted stickerTake our poll: what will be the fates of the stem cell clinic firms sued by the FDA one year from now in October 2019?

To be clear, I am asking for your predictions, not what you hope will be the situation a year from now.

U.S. Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center along with its parent stem cell clinic chain Cell Surgical Network were separately but in parallel sued in May by the FDA via the DOJ seeking permanent injunctions on what the FDA has indicated are non-compliant practices using unapproved stem cell drug products.

To my knowledge, these firms continue to sell the stem cells in question, which are adipose stem cell injections sometimes referred to as “stromal vascular fraction”. I also haven’t seen any indication that the firms are going to voluntarily stop what they are doing or that the FDA is aiming for a temporary injunction. Things have been awfully quiet on this front, at least in the public domain.

With this context in mind for today’s 3 polls, one year from today, what will be the status of these firms? Do they face similar outcomes? Will anything be different in October 2019 versus today? Will there be impact on California Stem Cell Treatment Center but not the whole big network that it leads? No change at all? What about USRM?

You can also weigh in on the polls or these situations in the comments.

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