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.
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.