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.
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.
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.
12 thoughts on “My take as a biologist on US Stem Cell “natural” claim in federal court case endgame”
Crystal, happy to hear that you are pain free and happy. I cannot know if this is related to the SVF or a multitude of other factors as you are a patient reporting an improvement with no other patients reporting no improvement in an identical setting but without SVF. This is the dilemma for the FDA as one person makes for very poor statistics.
But I guess your question about a possible relapse and what to do then. Well let´s say you experienced one of two results, in one the SVF was responsible for your improvement and in the other it wasn´t. If it wasn´t SVF then continue what you were doing before and after treatment as this is what helped, including diet, physical exertion, etc.
If it was SVF, the only property of these cells that is likely to have made any difference is their powerful anti-inflammatory activities. There are many other anti-inflammatory drugs out there, some long lasting, so you should be able to achieve the same effect.
I know, it´s a bit of a boring answer and you don´t get that “magic bullet” feeling. But you save a lot of money and aren´t risking a health threat from SVF that is not approved and still harbors risks. If you still want a magic bullet feeling, take your money and go to Nevada and smoke some leaf – it also has powerful anti-inflammatory properties (allegedly 😉 ).
Thank you, John, for your clarifications. I’m not an expert at this. I am “claiming” that I am a successful recipient of stem cell therapy. My future was bright. I was happy being pain free, loving life with no drugs. I am very worried about my future. What are my alternatives now?
“These are MY cells. I own them” – no you don´t, US Stem Cell does, check the agreement you signed with them. The minute they are removed from you they are owned by the clinic.
“I pay them to store them.” – correct, but now they will destroy them so obviously you won´t pay any more.
“How is the FDA ever able to approve this treatment without studies?” – it cannot. This is not an FDA approved clinical study – it cannot produce the type of robust statistically significant results that the FDA can use for approval. US Stem Cell is (was) not doing any clinical trials to gain approval.
“I don’t see anywhere where this judgement ever considered the thousands of people this treatment has helped.” You mean that it “claimed” to help. As I said above, the results are not the type that enables FDA approval decisions. What about the thousands more that it did not help – how do you figure that into an approval?
I am a stem cell patient. I have osteoarthritis and I’ve had 2 rounds of treatments in the last year which included IV. My stem cells were collected from fat tissue and I have them banked at US Stem Cell, Inc. It’s my understanding that I am part of a study. As part of the study, they contact me quarterly to see how I’m doing and ask me a bunch of questions. I currently have NO pain. My X-rays show knee and spine improvement. I have been pain-free for the first time in years.
I praise GOD for the blessing I’ve received thru my stem cell therapy. It has changed my life and I can function again with NO pain, no limp, I can crawl around on my hands & knees and get back up again. I can get in and out of my car with no pain. I can go grocery shopping without hanging on to the grocery cart.
I was notified by Us Stem Cell that they are ordered to DESTROY my stem cells in 30 days. Well, that’s not much time for me to react and figure out what to do, if anything. What I don’t understand is why US Stem Cell, Inc has to DESTROY my stem cells. These are MY cells. I own them. I pay them to store them. How is the FDA ever able to approve this treatment without studies? I don’t see anywhere where this judgement ever considered the thousands of people this treatment has helped.
How can my own stem cells used in my body be considered a drug?
I CHOSE this alternative treatment. I feel safe that my stem cells were being stored for future use. Now I’m flapping in the wind with nowhere to turn. I’m devastated and I curse the stupid judge that passed this hasty ruling and disrupted so many lives.
By definition PRP and Bone marrow aspirate as well as Amniotic fluid and membrane are routinely use in orthopedics and elsewhere for non homologous use which is apparently acceptable. Bone marrow is hematopoietic and not homologous to joints as are platelets (there is plenty of fat in joints). I suppose both could be homologous if used IV. I can’t figure birth products in any fashion. The chiropractors are using Dr Caplans work as a reference to support cord blood stem cells.
To make this clear, I do not want to defend any stem cell clinic. The angle of the legal actions taken, however, is in my opinion misplaced.
I think there are very good arguments that put SVF into the category of not substantially manipulated products, mainly from the clinical perspective. At the same time, there is no evidence that the use of SVF poses a safety risk per se but solid clinical evidence for the use is still slim.
The discussion that I think needs to be had instead is one about ethical behavior as a physician, malpractice and accountability. It should be clear that all new treatments must be evidence-based to ensure patient safety. The use of a therapeutic tool against or without clinical evidence does not show that the tool is generally unsafe but that the indication was chosen without sufficient knowledge about a safe and efficacious application. Autologous cell therapy with unmodified cells (no modification of the desired therapeutic characteristics) is a somewhat abstract tool but a tool nonetheless. Nobody would call for the ban of scalpels because some physician chose to amputate a leg because of a sprained ankle. Prohibiting the responsible use and development of sound clinical evidence of and for the therapeutic approach is hindering the clinical development and ultimately has no benefit to the patient, in my opinion. The speed of development of good clinical evidence will be significantly lower and the cost of treatments to patients significantly higher to make up for the development costs. Every day, new therapies are developed through the responsible conduction of clinical trials. Clinical evidence for or against a therapeutic approach is generated outside of the FDA’s reach and patient safety is at the same time maintained if not elevated.
I believe, that not regulatory restriction makes a therapy safe but knowledge of it and responsible use in combination with enforcement of existing rules and regulations to hold reckless actors accountable through the appropriate channels.
Let’s discuss PRP then in the same context as the above with SVF being separated and concentrated out of adipose tissue. Is not PRP a separated and then concentrated product out of the larger milieu of whole blood? Just trying to get a conversation started regarding other “natural”, regenerative products that are being injected into joints (I am not in favor of any unproven substances/products/biologics being injected IV or intrathecally or in the orbit) in the context of SVF use vs. other very common treatments that oftentimes are not covered by insurance and paid for out of pocket…
@Jaime, You raise some valid points. I’m not an expert on PRP, but it does seem like the FDA treats blood products like it very differently from just about everything else. I don’t know if PRP having no actual cells matters too. I could be wrong, but the use of enzyme in SVF production seems to be a major point of difference as well. Paul
Interesting item, Paul. But what is important here, in many ways, is the imperative that drives the argument in the case. The lawyer’s job is to get the defendant off scot free. It is not to produce valid science. So anything the lawyer says has to be evaluated in the context of his/her goal. No benefit accrues to the lawyer or defendant if their scientific presentation is accurate but then fails to acquit the defendant.
Again, I wonder how much judges dig into the medicine and science themselves.
It never seems to end and there appears to be no one willing to enforce the basic regulations designed to protect patients from scams and injuries. In Tucson we have color full-page ads running in our newspapers every other week for a place called Stem Cell Centers. They operate 8 or 10 clinics in AZ and California. Despite contacting the FDA, FTC, DOH of those states and state boards of medicine nothing has been done it seems. I worry that we will soon see a repeat of the FL incidents with those unfortunate patients.
@DrDavid, It is discouraging at times, but some wheels are slowly turning. It’s just the clinics & suppliers are moving so quickly so a lot of risk is generated.