FDA warns Mother Stem Institute & Alvaro Skupin

The FDA just warned a Florida stem cell clinic firm called Mother Stem Institute run by Dr. Alvaro Skupin.

Background: Mother Stem Institute past issues

I’ve written about this clinic and Dr. Skupin in the last few years. Just about a year ago I blogged the news that a patient suit against the clinic was settled. A clinic customer had alleged losing vision after visiting Mother Stem Institute. Here’s my 2021 post on this stem cell lawsuit for more background.

One thing that stood out to me was the marketing of stromal vascular fraction or SVF for a variety of conditions. For instance,  the firm has at times marketed SVF for Alzheimer’s. I don’t believe there’s good clinical trial evidence to back that up.

Alvarez and his wife, Dra Nancy Alvarez (who is also a leader at the clinic but not a physician as far as I can tell), promoted stem cells in various ways.

FDA warning to Mother Stem Institute

The new FDA warning letter details numerous areas of concern.

It has bullet points on Mother Stem Institute marketing:

“Under a title of “Who benefits from Stem Cell Treatment”: “People who have common symptoms such as physical exhaustion, stress, insomnia, as well as people with chronic degenerative diseases such as type I and II diabetes, osteoarthritis, Parkinson’s. It also favors people with autoimmune and inflammatory diseases such as Lupus, Rheumatoid Arthritis. An extensive list of diseases can be mentioned…” “The best thing is this treatment is available to everyone in our facilities…”

Again, where are the data to back these things up? For instance, why would SVF help with basic things like tiredness or sleep? Conversely, what is the evidence it works for big challenges like diabetes and Parkinson’s?

The FDA also notes in the letter that the SVF appears to be an unapproved drug.

If you are a cell therapy wonk you might find some of the extensive FDA details on why they define this particular SVF product as a drug to be interesting. The argument relates to things like minimal manipulation and homologous use.

Finally, this letter cites some research articles at the end, which is interesting.

Other SVF firms?

There are scores of firms marketing SVF for dozens of health conditions. It’s possible the FDA focused its attention on this firm now because of the patient injury alleged in the lawsuit.

It’s also worth noting that the status of SVF as a drug (or not) isn’t clear at this moment in the U.S. That definition in part depends on the pending 9th Circuit Court appeals case on use of SVF by several California defendants who won their initial case with the FDA. I believe that judge’s initial ruling was flawed but we’ll see what the appeals court says. I’m not a lawyer and those judges are not scientists.

There is concern that the appeals court may be swayed by the recent SCOTUS ruling negating something called Chevron. That was a precedent that gave agencies like the FDA more authority in federal courts. Now such agencies may face more challenges.

Notably, the FDA sent this warning letter despite the uncertainty surrounding oversight of SVF and lab-grown adipose cells more generally related to the pending appeal.

What’s next

I’m curious how Mother Stem Institute will reply to the FDA’s warning if such details do become available. Will they continue marketing SVF?

What if the 9th Circuit rules that SVF isn’t a drug during this same period? Would that at least in part negate the warning?

That appeals court ruling could be a long time coming.  It’s already been seven months since the court held a hearing on this case. I reached out to the court to query about the lengthy period with no decision. They replied, “The Court has no time limit to decide a case, but most cases are decided within 3 months to a year after submission.”

Hopefully, some of the gray areas here will be resolved before the end of 2024, but the way it’s looking this could push into 2025.

For more background, see this explainer post: What is an FDA warning letter & how should firms respond?