A stem cell clinic in the Cell Surgical Network chain has just been sued allegedly for causing vision loss in a patient.
By my count, across the U.S. this makes at least 5 patients who have said they were either totally blinded or had some major vision loss after getting stem cells injected into their eyes at various clinics.
I think the number is actually substantially higher.
Cell Surgical Network clinic doc Alvaro Skupin
In the new suit in Florida, attorney Andy Yaffa has filed against the clinic on behalf of patient Esperanza Cruz.
The defendants in the case are the following as quoted from the suit:
ALVARO H. SKUPIN, M.D., MOTHER STEM INSTITUTE, INC., NANCY ALVAREZ, SOLCEMA LLC, DRA NANCY PRODUCTIONS, INC., and PSICOAXIS CORPORATION
I recognized the name Mother Stem Institute, but I was trying to place whether I’ve heard of Dr. Skupin before.
Nothing immediately came to mind so I did a Google search.
This search turned up that Dr. Skupin is listed as a physician in the Cell Surgical Network chain of stem cell clinics.
See screenshot below.
What does this mean?
Pending FDA lawsuit; past vision loss case
Many of you may recall the FDA lawsuit against Cell Surgical Network, et al. The FDA is seeking a permanent injunction against them. That trial is done and the fate of that case is sitting on the desk of federal district court Judge Jesus Bernal here in California.
I expect a verdict any day now, but no one can predict which way it’ll go.
You can read up on that case yourself here on The Niche in my past posts and elsewhere on the web. But one key issue is whether fat cells are a drug requiring FDA approval to use.
It’s also notable that a past case of vision loss was alleged at another stem cell clinic in the same chain, this one in Georgia. I believe that case was settled.
Note that Cell Surgical Network is not a defendant in the new Florida case. It’s possible the network leadership had no idea what this particular Florida doctor was doing.
That’s a risk of having such a large chain of clinics.
The new case: vision loss due to eye injection
In the new lawsuit, Ms. Cruz is alleging that the defendants gave her a stem cell injection into her eye(s) as sort of a freebie on top of getting injections for arthritis in her hands. This was apparently part of their so-called “Stemprocell” protocol.
It’s not clear from the court filing whether she received blood, adipose cells (stromal vascular fraction?), or some combination of both in her eyes. None of it would make sense to me for vision loss.
Shortly thereafter the suit claims she had a catastrophic adverse event in her left eye due to the injection and lost vision in that eye. I’m not clear on whether she alleges any problem due to the injection in her other eye. Maybe it wasn’t injected?
This situation seems very reminiscent of the past cases of vision loss elsewhere including at U.S. Stem Cell, which itself was sued by the FDA. The agency won a permanent injunction against them.
Why is anyone still doing this kind of eye stuff?
What’s the Mother Stem Institute?
If you go to a Google-translated version of the Mother Stem Institute website (default is Spanish; note that stem cells in Spanish translates to mother cells) you can see that they claim to treat more than 20 different health conditions with Stemprocell. The claims include such diverse conditions as ALS, MS, ED, autism, and more.
In my view as a stem cell biologist, it seems highly improbable that a single adipose cell product can do all that.
Also, how could Dr. Skupin have the needed specialty training to safely and effectively treat patients with such diverse conditions? This is a common problem at clinics with a huge menu of health conditions they can supposedly treat.
The website reports that Dr. Skupin is “a certified specialist in internal medicine, pulmonology, sleep disorders, and intensive care.” That sounds like a lot, but what about some training related to vision? Ophthalmology? I don’t see any evidence of that. Rigorous stem cell training?
He seems to primarily be a pulmonologist.
Big picture
What happens next?
First, I hope the FDA quickly looks into this new case.
I sent a message to Mother Stem yesterday asking some questions and if I get a reply I’ll post it.
I wonder if this situation could impact Judge Bernal’s decision here in California. He’s two months into deliberating so maybe not. What’s more likely is that the sharply worded federal appeals court ruling earlier this year against U.S. Stem Cell, which mentioned Bernal’s case and it seemed to me conflicted with aspects of his earlier summary judgment ruling, could have an impact.
Overall, we can expect even more patients coming forward to say they’ve been harmed at clinics. I personally believe these patients.
Something big has to change.
Dr. Knoepfler. The issue at hand seems to me to be one of Judge Bernal deciding on whether or not the extraction of SVF or adult autologous stem cells from fat tissues comprise a drug that the FDA needs to regulate. Judge Bernal can hopefully see the distinction between that and cases of blinding the result of medical procedures which seem to me a different issue involving a type of mal practice. Hopefully, he will not conflate the two. The practice of medicine never would have gotten out of the dark ages if all folks did is simply look at tragedies that have historically taken place in every single field of medical practice. Even, and perhaps especially, in the face of tragedy like this case and others you described above, cooler heads need to prevail. Medical practices that we take for granted today to include, but not exclusive to, x-ray, blood transfusion and general surgery all faced opposition in their attempt to become part of mainstream medicine at one time. People and institutions need to make mistakes and fail on occasion in order to evolve. There is no free lunch here. The question that you posed to me on whether I care the result of my failure to mention “the woman who allegedly entirely lost her vision in one eye” seems a bit reactionary to me. I disagree with some of what you post on your blog but I do have feelings of empathy and sympathy for those that I do not know. Like I said previously, cooler heads in this debate about whether or not adipose derived stem cells are drugs needs to prevail. I am hopeful that Judge Bernal is up to the task.
If you readf the article, the problem is the technic, no for stem cell used, doctors who have no expertise perform treatments for which they are unaware of the techniques, and doing danger treatments.
This comment (NOVEMBER 21, 2021 AT 9:08 AM – The one to which you just responded) was posted as a reply to your reply to his post. This one ended up as it’s own comment as well, and not as a reply to your comment in that thread. Basically, when I reply to someone’s comment, my replies are not showing up in the thread. They show up as if I am comment directly on the article. I hope that I am making sense!
Thanks for letting me know. I’ll look into the threading of comments.
This happens because there are doctors who do not have expertise in performing treatments and do not know the techniques. This is not a complication of stem cells, it is a complication of inexperienced doctors who practice without knowledge, this doctor is not an ophthalmologist.
@admin – I posted a comment to A. Rahman Ford but it didn’t end up here. This isn’t the first time it’s happened. Do you have any idea why? A comment such the one I made “Because that doesn’t fit the intended narrative.” doesn’t make any sense unless it appears in the proper context of replying to someone else’s comment. I can’t figure it out. Help please?
I don’t see it in spam or deleted comments. Can you submit it again?
Because that doesn’t fit the intended narrative.
n=1 from a poli-sci guy isn’t terribly useful information, and certainly seems a less credible source than an actual cell professor.
And you don’t mention the countless people around the world – like myself – who have BENEFITED from SCT. Don’t you care about that?
@A Rahman Ford,
I’m glad your impression is that you were helped, but one person’s experience is not much data to go on.
The advantages of a chain business is the revenue (eg McDonald’s), but the downside is lack of control of the individual businesses. I’d like to see CSN take more responsibility for the people they take in as partners.
Please define “chain of clinics”. Are there licensing, royalties, or kickbacks involved?
Check out their website and you see a vast array of clinic/doctor listings in the “network”. To my knowledge some shared protocols, devices, etc. may have been used by participants.
I wonder if Judge Bernal is going to cite the FDA for making that apparently illegal one word change in their Code of Federal Regulations. You know? The one where they swapped out the word “ANOTHER” and put in its’ place the word “A” which means they essentially gave themselves increased regulatory authority. Authority which was only supposed to apply only to the allogeneic use of our cellular material. Supposedly this word swap on their part violated the Administrative Procedures Act of the 1940’s. By making the one word change in around 2006, I think, the FDA gave itself regulatory authority over not just the allogeneic but the autologous use of our cellular material. This places them squarely into regulating the practice of medicine by essentially calling our body parts drugs. They were never given the mandate to regulate the practice of medicine.
When it comes to regulating the practice of medicine, to me the FDA is the wrong tool for the job.
Doug,
We can argue different points of federal oversight, but –>
You don’t even mention the woman who allegedly entirely lost her vision in one eye? Don’t you care about that? What about the fact that this eye injection was done despite the well-publicized past cases of people being entirely blinded by apparently similar injections?