Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter.
While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in supply.
Why did Liveyon chose to halt sales at least for the moment?
By comparison other clinic-related firms have continued business as usual despite various FDA actions against them so I think the Liveyon decision is notable.
I can’t help but wonder if the podcast Bad Batch in a sense raised the stakes for Liveyon in continuing. It may have also contributed to the timing of the FDA warning letter to the firm.
I asked Liveyon leader John Kosolcharoen by email about the halt on sales and the warning from the FDA. Here’s what he said:
“I feel like the FDA is trying to slow down the expansion of the industry by making an example out of Liveyon because of its high public profile. Twenty one warning letters were sent out and the only notable news story is about Liveyon. With that being said, I have an incredible responsibility to make an example for everyone to follow. The only way to legitimately prove to the world that Liveyon is serious about science, is to follow the guidelines that have been set by the agency that rules this industry, and let the outcomes speak for themselves.Liveyon is not closed. This is just the beginning of the next chapter, in the story of the hard road to success. If it were easy everyone would do it, and many new companies have entered the space to try and capture their share of the market. I only hope they take this industry as serious as I do, and put in the time, money, and effort to do it right.”
This step by Liveyon could have other repercussions. My recent paper argued for a “stem cell and regenerative medicine ecosystem” where actions in one part can reverberate across it to affect others, for better or worse. In another part of the stem cell clinic universe, somehow it seems like a long time ago when fat stem cell clinic firm US Stem Cell Inc lost its federal court case and got a permanent injunction slapped on it (pending appeal), but it was actually only a few months back. That was a huge deal. Does it resonate with the Liveyon situation?
While the California federal district court case also related to fat stem cells/stromal vascular fraction (SVF) involving Cell Surgical Network/California Stem Cell Treatment Center likely won’t be resolved until sometime next year, I see US Stem Cell’s court loss as putting some serious chill on the fat stem cell clinic arena more generally. If so, this may tend to be seen as a competitive advantage to other kinds of stem cell firms unrelated to adipose including those in the perinatal arena such as Liveyon and the clinics it supplies, but now the recent events with Liveyon getting warned and quickly halting sales also put the squeeze on in that specific area.
Does this combination then in turn aid the bone marrow-related stem cell clinic firms? My initial reaction is that I kind of doubt it. Do these events put a chill on unproven stem cell clinics generally including bone marrow ones like Regenexx? We can’t be sure yet, but I think things are going to be substantially different after the next 1-2 years.
Because once they received the warning letter categorizing their products a 351 drugs, they had to choose between the IND approval route or fighting the FDA in court while continuing to sell product until the FDA gets an injunction and ultimately shuts them down – but they can’t do both. I find it hard to believe that the FDA would work with Liveyon on approval while they are simultaneously suing Liveyon for marketing and selling an unapproved drug.