Rancho Santa Margarita man linked to unauthorized drug sales gets 3 years in prison – Orange County Register

A Rancho Santa Margarita man who ran a company that marketed unapproved stem cell-based products that resulted in multiple hospitalizations was sentenced Monday, Sept. 30, to three years in federal prison.

According to the U.S. Department of Justice, John Kosolcharoen, 53, of Rancho Santa Margarita pleaded guilty last month in a federal case to introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead.

Kosolcharoen is already serving a sentence for a separate, unrelated conviction.

According to court documents, beginning in 2016, Kosolcharoen founded two companies, Irvine-based Liveyon and San Diego-based Genetech, to manufacture and distribute injectable stem cell products from human umbilical cord blood.

Liveyon marketed the products under various brand names, including ReGen. Kosolcharoen pleaded guilty and admitted that he and others falsely represented ReGen as suitable for the treatment of various diseases such as lung and heart disease, autoimmune diseases, Alzheimer's and Parkinson's.

According to federal prosecutors, until approximately April 2019, Liveyon marketed the products in the United States using promotional materials that contained numerous false and misleading statements about their purported safety and effectiveness.

“This defendant recklessly endangered people’s lives and gave false hope to patients with serious illnesses,” U.S. Attorney Martin Estrada said in a statement.

Kosolcharoen admitted that, in order to mislead the FDA about Liveyon's activities, he falsely stated in Liveyon's orders that the stem cell products were sold for research purposes only.

In 2018, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention received reports of patients in several states who were hospitalized for bacterial infections after taking Liveyon products.

Kosolcharoen admitted that he and others fraudulently induced customers to purchase Liveyon stem cell-derived products by, among other things, misleading the public about the cause and severity of adverse events in Liveyon patients and material facts about them falsely reported the result and concealed it from an FDA inspection of Genetech.

According to FDA records, this inspection documented evidence of significant deviations from good manufacturing and fabric practices.

“Unapproved stem cell treatments not only endanger public health, but also abuse the hopes of patients seeking relief from the most serious illnesses,” said DOJ Assistant Attorney General Brian Boynton.