A patient who got scientifically unproven and non-FDA-approved stem cells from Dr. Alvaro Skupin, filed suited against him, his wife who is often known as Doctora Nancy or Dra Nancy Alvarez, and associated businesses. These firms include the stem cell clinic known as Mother Stem Cell Institute in Florida, where the injections apparently took place.
I’ve written before about this stem cell lawsuit. It’s another disturbing vision loss case. Note that Dr. Skupin is not an eye specialist.
Although the case is now settled, I believe the FDA should investigate this situation for several reasons.
Let’s start with some brief background.
Lawsuit against Alvaro Skupin & Dra Nancy Alvarez alleged vision loss
The plaintiff Esperanza Cruz, represented by attorney Andy Yaffa who has handled and won many such cases, alleged that Skupin, Alvarez, and their businesses damaged her vision. A news story from NBC in South Florida on this lawsuit has this quote from Yaffa:
“He injected not only the bad eye, he also injected the right eye, the good eye,” Yaffa said. “She is now blind in her good eye.”
From the stem cell lawsuit filing:
“Ms. Cruz has suffered permanent and irreversible damage and vision loss as a result of the Defendants’ administration of the Defendants’ stem cell product and treatment.”
How could this happen?
No one should be injecting fat cells into patients’ eyes anymore and that was true even in 2020.
There has been widespread news coverage and published papers about the damage of the adipose cell eye injections by another Florida firm, US Stem Cell. These shots blinded patients well before this Skupin case. The FDA sued and won an injunction against US Stem Cell Clinic, which was also in the news.
Were Alvaro Skupin and Dra Nancy Lopez still somehow unaware of that previous damage to eyes from such injections? Didn’t see news of the federal lawsuit in Florida?
Did their clinic use an unapproved drug product?
The product used was also unusual.
The initial court filing and amended complaint in this newer case both mention that Skupin mixed blood and fat cells into a combination cellular product:
“Defendant Skupin drew 50 cc of blood from the antecubital vein and 50 cc adipose tissue by performing a liposuction procedure on Ms. Cruz’s abdomen. The blood and adipose tissue were then processed via the Defendants’ “Stemprocell” protocol, rendering the stem cell product that would be injected into Ms. Cruz’s wrists.”
This raises the question: was the resulting Stemprocell product an unapproved drug?
The fat cellular product SVF alone is a cell drug according to the FDA. Stemprocell sounds like it might contain something like SVF. There are mentions of Stemprocell on the web that suggest it has an SVF component.
The product mixing is important too. While the drug status of fat cell preps like SVF is not entirely resolved and is pending a Ninth Circuit Court appeal of the Cell Surgical Network lawsuit decision that went against the FDA, just the act of mixing blood and adipose tissue or cells into a hybrid cellular prep likely makes the resulting combination a new drug. Only the FDA makes such determinations though.
Again, the FDA should quickly look into this situation.
Dra Nancy Alvarez and Mother Stem Cell Institute
What was Nancy Alvarez’s role in all of this?
She reportedly owns the clinic, Mother Stem Cell Institute, where Cruz got the injections. As I said, Alvarez goes by Doctora Nancy or Dra Nancy Alvarez on social media and is widely known for her videos. She is not a medical doctor.
The plaintiffs alleged that Alvarez not only owns the clinic, but also had been widely promoting the use of stem cells for various conditions. This includes talking about them on her YouTube channel, which has more than half a million subscribers. Yet from NBC in South Florida:
“…Alvarez says her statements on her show about stem cell treatments helping her personally are not an “express warranty.” She goes on to say she didn’t sell or merchandise the products Cruz received.”
That seems to me like wanting it both ways.
Looking ahead
As I noted, the parties have now settled this case and, not surprisingly, the details remain confidential. In a follow-up post I will discuss the amended complaint in the case, which is in the public domain. It has some unsettling details.
Are Mother Stem Cell Institute and Skupin still doing stem cell procedures on customers? Their website is still up and seems to be marketing adipose stem cell type procedures of various kinds.
I hope no other clinics inject people’s eyes with unproven cells, but there’s reason to think it might keep happening, especially without more action from the FDA.
Glad you covered this lawsuit !! I also followed along on this one, stunned that it even occurred given it’s “in the backyard” FL area of where the US Stem Cell Clinic (Kristin Comella et al) blinded numerous innocent ladies. More troubling in this particular “Dr Skupin” case IMO, was that the formal complaint describes how the female patient-victim was “hooked in” via very, very slick advertising on the part of “Dra Nancy” and her various shows (I believe most or all done in Spanish, aimed at the Spanish speaking community). The victim was not in FL, but lived a few states over but saw the “Dra Nancy” show(s) and thus travelled to the FL Skupin clinic for “Arthritis of her hands to be treated via stem cell injections” and THIS is where it turned into a total mind blower. Attorney Yaffa via discovery and in his formal complaint described that the patient, prior to getting her hands/wrists injected, just happened to mention that, “Oh, and I have some problems with my eyesight” (paraphrasing). The Skupin clinic responded, “Oh, no problem as we can treat those eye issues at the same time via injecting stem cells into them also” (again paraphrasing). Unbelievable !!! That clinic literally w/ no sending the patient to an eye specialist, with no actual eye testing or exam really of any kind, literally offered the victim a “Two for one deal” where she for a “small” extra fee, got her eyes injected as a “package deal” for what started as hand/wrist arthritis SVF stem cell injections. That is what the lawsuit explained. It’s beyond the pale to me.. Like going in for surgery to have a broken bone fixed and mentioning you have had some stomach pain – and with no real examination or tests or anything, the surgeon says, “No problem, for $3K more, I’ll just take your appendix out while I’m operating and lets see if we can fix that stomach problem for you too – and oh, I’ve never done an appendectomy before but this will be a great learning opportunity for me” !! This stuff is so, so, so “Wild West” and just egregious – it’s hard to believe these are real cases sometimes ? What M.D. or doctor who swore an oath would ever, ever do these things to human patients ? The eyes of all things – and Skupin has zero training in treating any diseases of the eye, let alone sticking needles into them and injecting “stem cell goo” based on a “verbal exam” because the patient merely said, “My eyes are having some problems too” ? I’m at a total loss anymore trying to grasp this clinic “stuff”, for lack of a better word(s) and to keep this PG-13 here !!
@Rick,
After all these years I’m still surprised at some of what goes on at stem cell clinics in the US.
I bet there are still places injecting people with animal stem cells in the US.
For awhile there were human ES or iPS cell injections offered, even though they could give people teratoma.
The general failure of state medical boards to tackle and prevent some of this stuff is just mindboggling too. Here in CA we have more than 100 clinics and some of the docs at certain clinics are doing really bad stuff but the CA med board has taken no real action that I know of despite being aware of the problem. Apparently the FL medical board is even worse.