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.