A sentencing hearing scheduled for Monday has been postponed for one week for a man from Orange County who founded a company that sold unapproved stem cell-based products connected to several hospitalizations.
John Kosolcharoen, 53, from Rancho Santa Margarita, admitted guilt last month to a federal charge of introducing an unapproved new drug into interstate commerce with the intention to deceive, as stated by the U.S. Department of Justice. He is currently held in custody for a different conviction and is set to be sentenced on September 30 in Los Angeles federal court.
Kosolcharoen established two companies, Liveyon LLC based in Irvine and Genetech Inc. in San Diego, which manufactured and distributed injectable stem cell products made from human umbilical cord blood. Liveyon sold these products under various brand names such as ReGen, claiming they could treat a range of conditions including lung and heart diseases, autoimmune disorders, Alzheimer’s, and Parkinson’s disease.
The products were marketed nationwide until April 2019 with misleading advertisements regarding their safety and effectiveness, leading to severe consequences for patients. Kosolcharoen’s actions were criticized by U.S. Attorney Martin Estrada for endangering lives and providing false hope to seriously ill patients.
To deceive the FDA about Liveyon’s activities, Kosolcharoen falsified purchase orders to claim the products were for research purposes only. Reports of patients in multiple states being hospitalized due to bacterial infections after using Liveyon products prompted investigations by the FDA and CDC in 2018.
The FDA inspection revealed significant deviations from good manufacturing and tissue practices at Genetech, which were hidden from the public. Kosolcharoen could face up to three years in federal prison for his fraudulent activities that not only jeopardized public health but also exploited the desperation of patients seeking treatments for severe diseases.
The DOJ’s principal deputy assistant attorney general, Brian Boynton, emphasized the dangers of unapproved stem cell treatments and the false promises they offer to vulnerable patients. The City News Service also contributed to this report.