Dissecting Liveyon FDA inspection report & troubled perinatal stem cell industry

The perinatal stem cell clinic supplier Liveyon has had many issues recently including an FDA inspection that  in my view didn’t go well and which I’ll return to in a minute. First, some background on the company and this troubled industry.

E. coli and other pathogens ended up in some of the Liveyon product somehow prior to injections of it into patients at clinics. There was the recall.  A dozen or more patients ended up in the hospital. Patients lawsuits stemming from that are pending.

Then there was the recent scathing (appropriately so in my opinion) investigational report on the perinatal stem cell clinic industry co-published by The New Yorker and ProPublica by Caroline Chen in which Liveyon featured prominently.

More broadly, the unproven perinatal “stem cell” industry is a chaotic but growing sector that in my opinion has little benefit to offer patients in the way of proven safe and effective products. It does pose many risks.

I’ve regularly covered this subsector of the larger unproven stem cell clinic field within the even larger overall stem cell ecosystem for years. It’s been hard to watch and in my view, it is not only generally bad for patients, but also is harmful to legitimate research on perinatal stem cells.

Liveyon has tried to reboot itself more recently with a “new supplier” (basically itself?). From Chen’s report:

“Now Liveyon is making its own product, from umbilical cords that it buys from a public cord bank, Kosolcharoen said. The bank, which he declined to identify, sells donated cords that don’t meet FDA standards for treatment of blood disorders, he said. Liveyon, he noted, uses them for a different purpose — to create stem cell products. He called the new treatment “clinical trial grade” and said that Liveyon plans to start trials to prove its safety and benefits. But, even before conducting trials, Liveyon is already marketing the product, which it calls Pure, with the tagline “The Pure Feeling of Healing.”

So circling back, some months ago, Liveyon was also inspected by the FDA. I found the 483 inspection report, which you can see here.

In my view the report isn’t good, to put it mildly.

Eight observations (I would translate the FDA-speak “observations” here to “problematic issues”) were listed including in my view some very serious ones. There are also more than 8 issues here overall as some of the observations have many separate bullet points such as “Observation 1” listing a number of serious adverse events.

Other specific issues mentioned by the FDA include deviations from proper testing and handling of their umbilical product. It’s not exactly confidence building.

The broader perinatal stem cell industry is very concerning and was a major focus of Chen’s article. Liveyon has some competition in this sector from other suppliers including perhaps most prominently the firm called Utah Cord Bank. For instance, a stem cell clinic doc named David Greene reportedly gets a product from Utah Cord Bank. Others do too. Chen spent a good amount of time digging into what Greene does and the history of Utah Cord Bank, including this telling passage:

“Around 2016, the bank began making two amniotic stem cell products, called StemShot and StemVive. (StemShot was later renamed Stemii.) Although the bank continued to store birth tissue, amniotic stem cells soon became its biggest moneymaker.

The Utah Cord Bank was co-founded by a man named Eliott Spencer, who holds a doctorate in biochemistry from Brigham Young University. When the bank started producing StemShot and StemVive, Spencer was the only scientist on the company’s management team and the only person who knew the recipe for making the products, according to two former employees who spoke on condition of anonymity. Spencer said in an email that the bank now has “more than one scientist and many technicians, as well as multiple people who know how to safely procure, process and package our products.”

Read Chen’s whole article. I highly recommend it.

Overall, in my opinion, the more we learn about the perinatal stem cell industry the clearer it becomes that it is risky for consumers and has a slew of problems. I believe that more action by regulators is urgently needed including the FDA, the FTC, and state bodies.