November 28, 2020

The Niche

Knoepfler lab stem cell blog

Groundbreaking defeat for US Stem Cell, fat stem cell clinic industry in federal court

In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc.

The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is a major defeat for them and for the hundreds of other unproven fat stem cell clinics in the U.S.

It’s a big victory for science, regenerative medicine, and patients.

U.S. Stem Cell Clinic staff including Comella on the right.
U.S. Stem Cell Clinic staff including Comella on the right.

I don’t know if US Stem can continue its fat stem cell injections pending appeal or if the injunction is immediately in force, but I’d guess the latter. The court will issue a separate judgement in favor of the FDA telling us more it seems.

Why is this news such a big deal?

U.S. Stem (including its subsidiary U.S. Stem Cell Clinic and going by the stock symbol USRM) has become one of the most well-known fat stem cell clinics firms at least in part because of the documented loss of vision in some patients.

Its leader Kristin Comella is an outspoken voice for adipose stem cell clinics and for the idea that autologous fat stem cells should not be regulated as drugs by the FDA. She is influential in the stem cell clinic world and other fat stem cell clinics have also taken up similar mantras.

U.S. District Judge Ursula Ungaro apparently saw things differently (rightly, in my view) in ruling for summary judgment for the government. From the court order I linked to at the top of the post is this key section, emphasis mine:

“The Court agrees with the FDA that there is a reasonable likelihood that Defendants will continue to violate the FDCA. Defendants’ violations of the FDCA are not isolated; they have continuously performed the SVF therapy in noncompliance with CGMP as evidenced by the continued violations found in the Form FDA-483’s in 2015 and 2017. D.E. 50-1 ¶¶ 29-30; D.E. 45 ¶¶ 13-17. Moreover, the violations are not merely technical; when confronted with the warning letter and Form FDA-483’s informing them of their noncompliance, Defendants responded not by bringing their practice into conformity with CGMP, but by arguing that they were exempt from FDA regulation. D.E. 45 ¶ 20; D.E. 26 ¶ 52. Lastly, the Defendants’ business will undoubtedly present opportunities to violate the FDCA in the future as there is no indication that they have now complied with CGMP or adequately labelled their product. Defendants offer no challenge to these arguments, and as such, the Court concludes that the FDA is entitled to an injunction under 21 U.S.C. § 332(a).12″

While US Stem might continue as a business and focus on other stem cell-related products such as amniotic or bone marrow cells, I see that as a tough adjustment. Just as likely is the possibility that they will move the fat stem cell offerings outside the U.S.

With this court ruling under its belt, the FDA now has a very strong foundation to go after other risky, non-compliant fat stem cell clinics, with the caveat that USRM is likely to appeal and it’s at least formally possible that USRM could win on appeal even if very unlikely at least in my view. Some physicians who had been offering a la carte unproven and non-FDA approved fat stem cell injections have already stopped doing so over the last 6-12 months so a chilling effect was already evident.

Now comes the arctic blast.

This particular phrase from the court order is the key one, “the Court agrees with the FDA that the SVF is a drug under the FDCA and subject to its adulteration and misbranding provisions.”

More specifically the court decision also does not bode well for the defendants in the other still pending federal lawsuit by the FDA, also focused on fat stem cells.

Overall, again in my opinion this news is positive for both patients and the stem cell field.

More to come as I have time to read the full order, I get opinions from legal experts (which I’m of course not) and we get the additional document from the court.

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