Liveyon leader John Kosolcharoen pleads to federal felony charges on stem cells

The stem cell clinic arena is a Wild West but perhaps few have been wilder than the perinatal stem cell clinic firm Liveyon run by John Kosolcharoen.

Now John Kosolcharoen has pleaded guilty to felony charges related to Liveyon’s activities including distribution of an unapproved cell therapy drug. He will be sentenced next month.

This development is historic in the stem cell arena. It can be seen as a case of accountability but the news raises tough questions for authorities too.

Liveyon and John Kosolcharoen way out on a limb

Liveyon made many over-the-top and it turns out false claims about their stem cell-related products. They had exotic marketing videos. A white Rolls Royce made an appearance. At times it felt like a stem cell reality TV show.

The product line focused on umbilical cord cells. I never was clear on whether there were living, real stem cells in the product. Ultimately, a Liveyon product ReGen ended up with bacteria in it. How the contamination happened remains unclear, but birth-related products have inherently higher risks for this.

Many of those people who received the Liveyon material ended up septic and some landed in the ICU. It’s a miracle that no one died. Liveyon caused much suffering.  The CDC reported on the dozens of cases of harm by Liveyon.

Kosolcharoen is currently in prison for separate charges related to healthcare fraud. We’ll see how the sentencing goes with the new charges specifically related to stem cells.

Raising awareness

I tried to raise awareness about Liveyon here on The Niche with many posts. I connected with Kosolcharoen over the years.

The podcast Bad Batch by Laura Beil told the story of Liveyon and Kosolcharoen maybe better than anything else.

Putting oneself out there to try to help people avoid risks related to unproven stem cells is largely a thankless endeavor. It comes with risks too like potential lawsuits. That never was even threatened in the Liveyon case, but one just can be sure.

Kosolcharoen was always cordial.

DOJ statement on Kosolcharoen plea

In the DOJ statement on the new plea, we learn a few more tidbits:

“According to court documents, beginning in 2016, Kosolcharoen created two companies, Liveyon LLC and Genetech Inc., to manufacture and distribute injectable stem cell products made from human umbilical cord blood. Liveyon marketed the products under different brand names, including “ReGen.” In pleading guilty, Kosolcharoen admitted that he and others misrepresented ReGen as suitable for the treatment of a variety of conditions, such as lung and heart diseases, autoimmune disorders, Alzheimer’s disease, Parkinson’s disease and others. Liveyon marketed the products throughout the United States until about April 2019 using advertising materials that contained multiple false and misleading statements about their purported safety and effectiveness.”

For example, it was somewhat unclear who ran Genetech (not to be confused with Genentech).

Historic case

This is one of the only federal criminal cases related to stem cell marketing even as hundreds of firms have potentially violated the law.

To my knowledge, Kosolcharoen did not have major scientific or medical training but seemed like a marketing expert. There are many people still active in the stem cell arena with similar backgrounds heavy on marketing.

I still worry about the public getting hurt.

Last year a Florida man Jimmy Lee Taylor was sentenced to more than 200 years in prison by Georgia on stem cell-related charges.

There should be more cases like this based on what I know both at the federal and state levels.

Team effort

This was a major government effort. From the announcement:

“FDA’s Office of Criminal Investigations, FBI, Amtrak Office of Inspector General, Defense Criminal Investigative Service, Department of Health and Human Services Office of Inspector General, Department of Labor Employment Benefits Security Administration and California Department of Health Care Services investigated the case.”

It’s good to see such cooperation and successful results.

Is there much hope for more action?

The Feds from different agencies have some strong words on crimes related to stem cells in the new DOJ announcement, but we’ll see what additional cases, if any, emerge. There is no lack of illegal distribution of stem cell drugs across state lines and fraudulent marketing.

Sadly, it seems like for many of the most worrisome stem cell clinic operators still out there, only the threat of criminal charges might be a strong enough deterrent to fully stop. I have often wondered if large fines could work too but we haven’t seen that happen.  Instead, firms mostly just get sternly worded letters.

Even when it seems a firm is in such hot water, it’s just too easy to start a new company with a fresh name (maybe even change your own personal name a bit) and keep on trucking. Some don’t even bother doing that and instead, they just keep changing their products with little accountability and big profits.

This case probably seems like at least some justice to those who were hurt, but it also highlights how little has been done overall. Maybe this success by the feds will spark more action that is urgently needed.