September 26, 2020

The Niche

Knoepfler lab stem cell blog

My take as a biologist on US Stem Cell “natural” claim in federal court case endgame

It’s been less than a year since the FDA sued for a permanent injunction against a major stem cell clinic firm in Florida, but there has been much back and forth in court filings in the lawsuit between them and the firm, US Stem Cell.

Now the case is with the judge.

My prediction remains that the feds will prevail, but it seems worthwhile to look at some of US Stem Cell’s arguments. Note as a sort of disclaimer that I’m not an attorney so I’m approaching this as a stem cell scientist and I may miss some subtleties or even obvious elements of court matters.SVF stromal vascular fraction

For the purpose of examining some of US Stem’s final arguments, let’s look at the recent response item that I see in Pacer that the defendants filed. There are some notable arguments in there in that document which is titled, “DEFENDANTS US STEM CELL, INC., US STEM CELL CLINIC, LLC, AND KRISTIN C. COMELLA’S REPLY IN FURTHER SUPPORT OF THEIR MOTION FOR SUMMARY JUDGMENT.”

A surprisingly narrow, but important area of dispute in this case seems to be over the meaning of the word “such” as relates to the term HCT/P (human cellular and tissue product).

I’m not kidding.

The “such” language argument seems to be mostly centered on the main point about the stem cell product discussed below.

It seems to me that a key assertion by US Stem Cell is that their production of adipose stromal vascular fraction (SVF; see my drawing of how SVF is usually made and note that the way each firm including US Stem does this is somewhat different, but you get the gist) does not substantively change the material from its native state in the patient’s body. As such, US Stem claims that they are eligible for the same surgical procedure exception (SSP) that would in that hypothetical case potentially make their production and use of SVF outside the scope of FDA drug oversight authority.

For instance, US Stem writes the following in that recent court document (emphasis mine here and in all the quotes):

“The Defendants’ SVF Surgical Procedure thus fits well within the SSP Exemption. The plain language of the SSP Exemption exempts procedures that occur during a single sitting in which the human cell or tissue that is put back into the patient is not significantly altered from the form in which it naturally exists in the same patient’s body. That is what happens here; nothing more.”

In my view, US Stem is not right about this.

My main reasoning is that SVF does not naturally exist in a patient’s body. Yes, fat with associated cells and vasculature, does exist in the patient’s body, but it’s not the same as the final SVF. Instead, SVF is a laboratory-manufactured product.fat quote

It might be helpful here to compare SVF to bone marrow aspirate, which is generally considered minimally manipulated as typically prepared because the marrow cells are basically the same inside the body as they are outside the body in the aspirate that is then injected into patients.

US Stem writes about the purported natural state of SVF again in the same document:

“The “rinsing, cleansing, sizing, or shaping” affects only the tissue that is discarded, and not the tissue that is put back into the patient, which is what happens here. Because the SVF is unchanged from the time it is removed from the body (as part of the adipose tissue, some of which is discarded) until it is put back into the body, it remains “in the form removed from the body.” Dkt. No. 41-1 at 13. The SVF is, therefore, “such HCT/Ps.” 

And then US Stem asserts the natural state for SVF a third time, “Accordingly, the SVF cells naturally existing in an individual’s body at the time of removal constitute “such HCT/Ps” when implanted into the same individual’s body as part of the SVF Surgical Procedure.” (note the insertion of the word “cells” here, which is interesting).

In fact, the word “naturally” is used 3 times in this document.

No matter how many times it’s written, I personally don’t buy it even if some others may agree with the argument of SVF being a “natural” (minimally manipulated) product. At a very basic level one could say that if SVF was not significantly different than patient fat, if you are a stem cell clinic then why not just inject the unchanged fat?

Beyond the more than minimal manipulation issues discussed above, there’s also the consideration of homologous use (or lack thereof). If a product is used in a non-homologous manner (e.g. SVF being used to treat non-fat-related health conditions like neurological conditions, many orthopedic issues, eye problems, sexual issues, etc.) that can also make it by definition a drug product requiring premarket approval too. It seems to me at least, that many of the reported applications of SVF are likely to be non-homologous.

However, I haven’t seen homologous use mentioned as much as things related to minimal manipulation overall including in this response document from the defendants. It may be that there’s some confusion over whether non-homologous use in the context of minimal manipulation could still be compatible with a SSP exception status. I’ve puzzled over that for bone marrow (see about 3/4 of the way down in this post) in the past, but my feeling was that for SVF that non-homologous use alone was sufficient to trigger drug classification based on FDA docs. It may be kind of a moot point if SVF is already a drug based on more than minimal manipulation, but adds to the basis for drug classification.

I’m curious, no matter what the verdict, how much the court will write in the judgment about the reasons behind her decision and how much biomedical science she will mention.

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