June 6, 2020

The Niche

Knoepfler lab stem cell blog

Reactions to historic stem cell clinic court loss, new court order, & what happens next?

It’s been a big week already for the stem cell field due to the court ruling against US Stem Cell Inc. and that the FDA can define stromal vascular fraction (SVF) as a drug (see my old rough sketch of how SVF is sometimes manufactured; my impression is that the company does this slightly differently).SVF stromal vascular fraction

There is a wide range of opinions on the long-term meaning of this court ruling. Some like me view it as likely making a major positive difference, while others are more skeptical.

You can see my two posts on it here and here.

But what are others including the clinic firm itself saying and planning?

In this post I’ve included a sampling of views that I thought interesting and a note at the bottom on a new, small court order that seems significant.

I’ll start with the take of Professor Patricia Zettler, who is an expert in biologics regulatory matters including in particular FDA oversight. Dr. Zettler is a Professor at The Ohio State University Moritz College of Law. I reached out to her and here’s her initial take, which was cautiously upbeat:

“I think this is the great news from a public health perspective, and the right outcome from a legal perspective, it is consistent with the Regenerative Sciences opinion. Hopefully this will encourage FDA to continue its momentum in this area.”

She added more later:

“I can add that this is a preliminary victory, in that the defendants may appeal. But I think it is an important victory, even if preliminary, for both FDA and the public health. The opinion agreed with, or deferred to, FDA on all of the key questions of FDA jurisdiction over the defendants’ stem cell products. That bodes well for FDA regulation in this area. It’s a victory for patients too, if this trend continues, because hopefully we’ll start to see fewer hyped, unproven interventions sold.”

This is largely similar to my view too, but Patti is far more of a regulatory and legal expert so I put a lot of weight on her opinion.

Stem cell clinic attorney Rick Jaffe posted just a quick initial reaction to the court decision yesterday on his blog here, but he seems more skeptical of this having major impact:

“I’ll write about this again, once I have reviewed the judge’s decision closely. While I think this decision is legally significant, practically, it will have less effect than the regulators might expect, because, as I’ve said many times before, this was expected and many in the field have moved on to new HCT/P’s and here we go again, from the beginning.”

Unfortunately, he might to some extent be right about some clinics moving on to other unapproved biologics, some of which could be equally concerning. In his blog post he also wondered aloud whether the defendants would comply with the injunction and he thought they would. Consistent with that, we see this statement quoted in the NYT:

“While we believe there is substantial evidence to prove the efficacy of this protocol, we must immediately comply with the court as we review the decision,“ the company statement continued. “US Stem Cell Inc and US Stem Cell Clinic will continue to operate business as usual, but will no longer offer the adipose/SVF procedure.”

I don’t see how it can be “business as usual” without them being able to do SVF. However, it’s good news that they are respecting the injunction.

Instead of fat, they may focus moving forward on bone marrow stem cell-related procedures, but birth-related or other stem cells could also be in the mix, based on this quote in the WaPo story on the court ruling:

“A spokeswoman said the company plans to continue offering stem cell treatments derived from bone marrow and other tissue.”

I haven’t seen compelling evidence of bone marrow stem cell products being proven safe and effective outside of the hematopoietic cancer/disorder arena such as for orthopedic applications, but If the company mainly focuses moving forward on minimally manipulated, autologous bone marrow materials used only in a homologous fashion, that’s at least going to be much lower risk than non-homologous uses of SVF in my view.

The use of amniotic or other perinatal materials could be more complex as if they are living cells and they are by definition allogeneic too and they are often used by clinics across the U.S. in a non-homologous manner, they may also constitute a drug product.

There was another small development in court. USRM asked the judge yesterday for an order for the parties to discuss the nature of the permanent injunction, and here was part of the court’s response:

“ORDERED AND ADJUDGED that the PARTIES SHALL FILE EITHER an agreed proposed order of permanent injunction or a status report, not to exceed five pages, outlining any remaining areas of disagreement by Friday, June 14, 2019. It is further

ORDERED AND ADJUDGED that UNLESS AND UNTIL this Court enters a permanent injunction, pursuant to the terms of this Court’s Order on the Parties’ Motions for Summary Judgment, D.E. 73, Defendants SHALL NOT sell, provide or otherwise engage in any SVF therapy or any other activities to be regulated by the FDA as explained in the Court’s Order on the Parties’ Motions for Summary Judgment. D.E. 73.”

To me as a non-attorney, it sounds practically speaking like a de facto temporary injunction is in effect. Lawyers out there — am I right?

I’m not totally clear though on a few things. Will USRM still be able to train others in the production and use of SVF as a for-profit service? I wouldn’t think so, but I’m not sure. Can they keep selling their kits?

The next issuance by the court on the actual ruling in favor of the FDA may help to clear things up.

More broadly, we’ll have to see how things unfold in Florida and at fat stem cell clinics across the US after this key court ruling for the FDA.

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