"Liveyon" founder convicted of distributing stem cell drug linked to multiple hospitalizations

The head of a company based in Southern California may spend the next few years in federal prison after he distributed an unapproved stem cell drug linked to multiple hospitalizations.

John Warrington Kosolcharoen, 53, faces a maximum sentence of three years in federal prison after he pleaded guilty to one count of introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead. 

He is currently serving a sentence for a separate, unrelated conviction. 

Kosolcharoen created Liveyon LLC and Genetech Inc. in 2016 to manufacture and distribute injectable stem cell products made from human umbilical cord blood. As part of his plea agreement, he claimed that one of the products, ReGen, could treat certain conditions, including autoimmune disorders, Alzheimer's, Parkinson's, lung and heart diseases. 

The US Department of Justice claimed the advertisements for ReGen and other Liveyon products contained multiple false and misleading statements. 

"This defendant recklessly put people's lives in danger, giving false hope to patients with serious illnesses," United States Attorney Martin Estrada said.  

Liveyon marketed these products nationwide despite not receiving approval from the Food and Drug Administration. The federal agency regulates stem cell products. Typically, these drugs cannot be sold without FDA approval. 

"When unscrupulous providers offer umbilical cord blood stem cell products and treatments that are both unapproved and unproven, they put consumers' health at risk, and multiple users of this firm's products in fact suffered adverse events," FDA special agent in charge Robert Iwanicki said.

In 2018, 12 people in three states needed to be hospitalized for bacterial infections after taking Liveyon products, according to the FDA and the Centers for Disease Control and Prevention. At the time, researchers wrote that the outbreak "highlights the serious potential risks" to people taking stem cell products for "unapproved and unproven uses."

"Our message to all consumers and providers is to 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," CDC Director Michael Bell said. "Please don't let products like these put you or your patients' health at risk."  

Part of his plea agreement also compelled Kosolcharoen to admit that he misled people about the cause and severity of adverse events suffered by Liveyon patients while also falsely reporting and concealing material facts about an FDA inspection of Genetech. He also admitted to falsely stating that Liveyon's purchase orders that the stem cell products were being sold "for research purposes only."

Kosolcharoen is expected to be sentenced on Sept. 23.