An individual from Orange County who operated a company selling stem cell-based products that led to numerous hospitalizations is set to be sentenced next month for illegally distributing a drug without approval from the U.S. Food and Drug Administration (FDA).
John Kosolcharoen, aged 53, formerly of Rancho Santa Margarita, pleaded guilty on Aug. 26 to a federal charge of introducing an unapproved new drug into interstate commerce with the intent to deceive and mislead, as per the U.S. Department of Justice.
Kosolcharoen is currently in custody serving a sentence for a separate, unrelated offense.
Court documents reveal that starting in 2016, Kosolcharoen established two companies, Liveyon LLC based in Irvine, and Genetech Inc. based in San Diego, to produce and distribute injectable stem cell products derived from human umbilical cord blood.
Under various brand names, including ReGen, Liveyon promoted the products. In his guilty plea, Kosolcharoen confessed to misrepresenting ReGen as a treatment option for various conditions such as lung and heart diseases, autoimmune disorders, Alzheimerâs disease, Parkinsonâs disease, and more.
Until around April 2019, Liveyon marketed the products nationwide using advertising materials that contained false and misleading statements about their safety and effectiveness, according to federal prosecutors.
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âThis defendant recklessly put peopleâs lives in danger, giving false hope to patients with serious illnesses,â stated U.S. Attorney Martin Estrada.
As per the plea agreement filed in L.A. federal court, Kosolcharoen admitted that he directed Liveyonâs purchase orders to falsely state that the stem cell products were meant for research purposes only to deceive the FDA about Liveyonâs operations.
In 2018, the FDA and the Centers for Disease Control and Prevention received reports of patients in various states requiring hospitalization due to bacterial infections after receiving Liveyon products. Kosolcharoen acknowledged that he and others deceptively persuaded customers to buy Liveyon products derived from stem cells by distorting the cause and severity of adverse events experienced by Liveyon patients, and by misrepresenting and concealing material facts about the result of an FDA inspection of Genetech.
According to FDA records, the inspection revealed significant deviations from good manufacturing and tissue practices.
âUnapproved stem cell treatments not only endanger public health but also exploit the hopes of patients seeking relief from severe diseases,â commented Brian Boynton, the DOJâs principal deputy assistant attorney general.
U.S. District Judge Otis D. Wright II has scheduled a sentencing hearing for Sept. 23, during which Kosolcharoen could face up to three years in federal prison, according to the DOJ.
