The former CEO of Liveyon — the stem cell company whose contaminated products sickened at least 20 people — has pleaded guilty to felony charges, according to the U.S. Department of Justice (DOJ).
John Kosolcharoen, who is currently in custody serving a sentence for an unrelated conviction, pleaded guilty to introducing unapproved new drugs into interstate commerce with intent to defraud and mislead, prosecutors said. He will be sentenced on September 23.
It’s one of the only federal criminal cases around stem cell marketing “even as hundreds of firms have potentially violated the law,” Paul Knoepfler, PhD, of the University of California Davis, wrote on his stem cell blog, The Niche.
Knoepfler said the development is “historic in the stem cell arena” and that it “can be seen as a case of accountability.”
In 2016, Kosolcharoen created Genetech (not to be confused with Genentech) and Liveyon to manufacture and distribute, respectively, injectable stem cell products made from umbilical cord blood, according to the DOJ. Products were marketed under different brand names including ReGen, Pure, and Pure Pro.
But in 2018, nearly two dozen people in the U.S. became sick and many had to be hospitalized because the Liveyon products were contaminated with several types of bacteria.
The CDC initially reported on 12 patients with bloodstream infections, joint infections, epidural abscesses, and other problems tied to the injections, but a subsequent investigation published in JAMA Network Open found infections in 20 patients — 19 of whom had to be hospitalized — due to the contaminated injections.
“The most frequently isolated bacteria from patients with infections were common enteric species, including Escherichia coli and Enterobacter cloacae,” the latter report stated. It also found that 65% of the 34 unopened Liveyon vials it sampled were contaminated with at least one of 16 bacterial species, mostly enteric.
In 2019, about a year after the infections came to light, the FDA sent a warning letter to Liveyon and a handful of other companies about their unapproved stem cell products. Liveyon was slapped for processing and distributing “unapproved” umbilical cord blood products, and FDA said it was also in violation of good manufacturing practices.
Around that time, a podcast about the infections called “Bad Batch” was published, and Kosolcharoen had given its reporter an extensive interview about the company and the stem cell product industry, which FDA has long been trying to curb.
Knoepfler said in his blog that Liveyon was atypical for such companies, as they usually try to keep a low profile. Instead, Liveyon made “exotic marketing videos. A white Rolls Royce made an appearance. At times it felt like a stem cell reality TV show,” he wrote.
According to the DOJ, 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.”
The company also used advertising materials that had multiple false and misleading statements about the safety and effectiveness of the products, DOJ said.
Both FDA and CDC officials provided statements for the DOJ press release. Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said the agency was “grateful” to DOJ for its work to “hold accountable establishments that prey upon vulnerable populations by marketing potentially dangerous stem cell products with false and misleading claims about their safety and effectiveness.”
Michael Bell, MD, director of CDC’s Division of Healthcare Quality Promotion, said patients and providers should “heed the warning against the use of unapproved products like these with unproven claims of effectiveness for conditions like joint disease, chronic pain, or COVID-19. Please don’t let products like these put you or your patients’ health at risk.”
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