August 9, 2020

The Niche

Knoepfler lab stem cell blog

The FDA has issued a recall of the main stem cell product of a California firm called Liveyon that is linked to unproven stem cell clinics. The recall seems to have been due to “adverse reactions.”

An emerging big player in the birth-related stem cell clinic area?

I’ve been hearing the name Liveyon pop up more often in the unproven stem cell clinic industry recently. More specifically, they seem to be a supplier and marketer of birth-related products to clinics. The clinics then in turn inject the non-FDA-approved offerings into customers for profit. I have only mentioned this particular company once on this blog before. It was in a post about a clinic that apparently used their product for neuropathy, which was not a recommended indication.

LIVEYON
Screenshot of part of LIVEYON homepage

The birth-related stem cell clinic industry more broadly has really taken off the last few years and now constitutes a sizable slice of the clinic pie across the U.S.

Liveyon has been part of that growth.

Umbilical cord stem cells + growth factors

The company’s splashy website (see image of part of the homepage) focuses on umbilical cord “stem cells”. I’ve never really been clear as to whether the products of this supplier and others in this birth-related area including amniotic materials actually have living cells or are just dead extracts (see my past post Wanted Both Dead & Alive).

From the Liveyon website:

“Liveyon provides high-quality, medical grade umbilical cord cells and growth factors for use in research studies for various degenerative diseases. By combining stem cells and growth factors, our product may give a longer lasting effect and improve quality of life for those suffering from debilitating diseases/ disorders, such as arthritis and orthopedic indications. Our product testing makes you, the skilled practitioner, feel comfortable that your patient is receiving the best product available in the market.”

This sure implies living cells. What are “medical grade” umbilical cord cells? Hard to say.

If the cells are indeed living and because they seem to be mixed with growth factors, in my opinion it would seem this product would require a cleared FDA IND prior to marketing or use in patients. I suppose the company could have an IND, but I strongly doubt it.

Thinking about the recall

What specifically made the FDA recall the Liveyon ReGen product series?

The FDA notice says, “Consignees were instructed to not use the vials, due to reported adverse reactions.” More broadly, I have heard of some apparent adverse reactions to birth-related “stem cell” products through the grapevine, but I haven’t confirmed any or gotten many more details. I wish we knew more about the adverse events here. Maybe we will learn more later.

The FDA verbiage suggests to me that Liveyon isn’t the manufacturer of its products, which is instead attributed to another company Genetech, Inc. (not to be confused with the well-known biotech, Genentech). I’m not sure what Genetech’s story is, but a different site suggests that they have 12 employees, $8 million in annual revenue, and that they also manufacture antibodies.

Looking ahead

Does Genetech send the same or similar products to other clinics and are those products of concern too?

How many people were injected with Liveyon’s recalled product? Will they have their health monitored? Again, what exactly were the adverse events and how many occurred?  I used the Liveyon’s “contact us” online form to ask these kinds of questions. We’ll see if I get a response.

Who runs Liveyon and are they some kind of expert? A physician? A highly experienced stem cell scientist? What do they have to say about this recall? Stay tuned.

Finally, I am curious as to whether the FDA will do anything more about this situation.

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