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).
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.
I RECALL SPEAKING WITH YOU, JEANNE, REGARDING MY DAUGHTER, WHO SUFFERS FROM PROGRESSIVE MS. YES, WE ARE DESPERATE, BUT TO HEAR OF PEOPLE WHO HAVE UNDERGONE QUITE A NUMBER OF STEM CELL TREATMENTS……OUT~OF~POCKET, WHO CLAIM NO SIGNIFICANT CHANGE……..SOMETHING SEEMS TOTALLY OUT~OF~CONTROL!!!!!!! CONSIDERING EXPENSE, & THREAT OF INFECTIONS, & OTHER RISKS, EVEN THOUGH ANYTHING , YOU GET NO GUARANTEES, THIS CASH SERVICE SHOULD INCLUDE SOME MONEY~BACK, IF NO CHANGE!!!!!! I NEED TO KNOW <<>> THERE IS TRULY ANYTHING SUBSTANTIAL TO CALL, DEPENDABLE FOR NEUROLOGICAL DAMAGE, WHERE STEM CELL TREATMENT IS INVOLVED????????????? IT APPEARS TO BE AN “EMPTY” BUCKET OF WORMS!
Fortunately, there ARE other ways to deliver autologous SVF stem cells that do NOT utilize enzymes and so CANNOT and ARE NOT covered by FDA pre-market rules. They are in use today in the US, fortunately, helping MANY patients like me.
Unfortunately, patients will continue to be harmed by the MILLIONS/year, and medical injury will CONTINUE to BE THE THIRD LARGEST CAUSE OF DEATH in the USA due to the UNWILLINGNESS of the FDA to FLEX their muscle when it comes to REQUIRING hospitals to REPORT ALL injuries and adverse events and REPORTING these data to the public.
Brad- The enzymes are only part of the problem. That’s the more than minimum manipulation part. The other part is homology- SVFs injected into the blood are not homologous use, and hit the second target even if enzymes aren’t used. Either way, the FDA regulates it. Regulation is good for us…we can drink the water anywhere in the US and be pretty sure that there aren’t bacteria in it that make us sick. We need more of it, so that our water also does not have lead or coal ash in it.
Dear Bill,
I checked the website you suggested. In general terms they discuss stem cells and growth factors, but aren’t specific on either one.
It is difficult for me to understand where the stem cells they use come from; whether they are working with telomerase-negative stem cells that are already committed to particular tissue types; whether they are working with telomerase-positive stem cells that are undifferentiated; or undetermined mixtures of both; where their growth factors come from, such as from platelets in the form of PRP (platelet rich plasma), or whether they are using tissue-specific human-recombinant proteins. Have they considered what effects their growth factors have on existing endogenous telomerase-negative and telomerase-positive stem cell populations within the tissue? Do they have any publications or white papers to explain their technologies?
Maybe their free website would answer these questions.
Welcome to CIRM lol https://www.regenmedmaine.com/about/
Thanks, Bill. Uh, I think that acronym is taken in the stem cell universe at least.
Let’s see what THE CIRM thinks about it.
Regulatory issues aside, I take exception with clinics that do not understand the developmental potential of the stem cells they are using for treatment. For example, Caplan’s mesenchymal stem cells are a tripotent telomerase-negative stem cell that will differentiate into fat, cartilage and/or bone. That information was known since 2000 when Mark Pittenger published the cloning and characterization of those cells. Having that knowledge why would anyone inject those particular stem cells into someone’s eyes. What were they hoping the stem cells would do? Personally, I would not want fat or cartilage or bone intervening between my retinal cells and incoming images. Makes no sense.
Apparently, you need to talk to Caplan.
Do you mean the change in names of his cells “MSCs” from mesenchymal stem cells (MSCs) to marrow stromal cells (MSCs) to medicinal secreting cells (MSCs)? The question stands – what cells are the clinics using and what is their final differentiation and/or function? My suspicion is they have no real clue as to the mixture of cells they use for their treatments. And that is the truly scary part.
Nice to see rulings that will protect patients in these matters. Can you also assure potential patients that like drugs, big pharma will not grab hold of this regenerative medicine and jack up pricing to line their pockets. If not, Americans will simply travel to countries that allow the use of these regenerative techniques and at reasonable prices. How long will it take for the FDA to move on with approved products? When and where are clinical trials happening? There is plenty of anecdotal evidence to suggest that adipose stems cells work for arthritis of the knee joint. Sports figures such as Tiger Woods and the Golden Bear have used these medical interventions with excellent results. Personally I know of several people that have gone from being crippled to once again enjoying life including dancing. Overall, I am concerned that all this posturing is more about control of a powerful medical tool and channeling the profits into the coffers of a selected few. I have already done my research and found Sports Clinics in other countries that can offer these services and at reasonable cost.
In a Phase II, placebo controlled clinical trial by Cytori Therapeutics completed in 2016 for knee osteoarthritis using adipose derived regenerative cells (SVF) , the treated patient group FAILED to do better than the placebo arm. This is probably the most well designed stem cell study on knee OA. Maybe a higher dose would have worked? Maybe a hydrogel added to the procedure would have helped? Bottom line is that this is the best evidence that I am aware of that clinics have nothing to back up their claims that SVF is any better than a placebo for knee OA. Here is the link… http://ir.cytori.com/investor-relations/News/news-details/2016/Cytori-Reports-Interim-Data-on-US-Phase-II-Osteoarthritis-Trial/default.aspx
Cytori has abandoned the stem cell business.
Thanks, @WST. That’s the key study to date. All the for-profit clinic-related data published is relatively weak generally lacking placebo controls, blinding, etc.
Paul, I’d be curious to know how you thinks this will effect the ongoing case against the Cell Surgical Network? Where do you see that going?
@Michael, I’m not an attorney, but common sense suggests the FDA suit against Cell Surgical Network, et al just became a far tougher case for the defense to win. The California judge could, in theory, still go his own way and rule against the FDA, but that was already perhaps a long shot before the FL verdict. Now it seems even less likely. Also, the SVF firms on both coasts are using the same law firm at least in part and my impression is that they are/were making similar arguments so if the defense case didn’t fly in FL district court, a similar case is not too likely to work in CA. But you never know.
I’m also curious to see if USRM appeals the decision (btw we are still awaiting the actual court ruling as the judge only decided on the summary judgement it seems), what argument they will try to make. It seems like an appeal would be expensive for the company and perhaps the odds would still be long, but they are passionate about their case for SVF not being a drug subject to premarket approval.
Thanks, Paul!
“Defendants SHALL NOT sell, provide or otherwise engage in any SVF therapy or any other activities to be regulated by the FDA…”
Someone can correct me if I am wrong, but this seems to be a very broadly worded order that prohibits not just SVF, but anything else that might be regulated by the FDA.
Jann Bellamy, who writes for Science-Based Medicine, and Dorit Rubinstein-Reiss, who contributes articles to the Skeptical Raptor, who are both attorneys, have expertise that may be helpful in this area.
Thanks, mdfinfer. I’ll reach out to them if I can find their contact info.