We, the undersigned, respectfully petition the President of the United States to grant a full and unconditional pardon to John W. Kosolcharoen, a pioneer in regenerative medicine, entrepreneur, and former CEO of Liveyon LLC, who was wrongfully criminalized under ambiguous and inconsistently enforced regulatory framework intended to govern the marketing of stem cells which are categorized as Human Cell and Tissue Products (HCT/P's).

John's journey began in 2013 when he suffered a serious knee injury. After experiencing a remarkable recovery through stem cell therapy, he introduced others including his own mother to the life-changing potential of regenerative treatments.  Motivated by these personal successes, John transitioned into the medical field, working on the business side with an orthopedic specialist, leading operational strategies to expand access to these breakthrough therapies.

John quickly became one of the most experienced professionals in the industry.  Though not a physician by degree, his operational knowledge and leadership in cellular therapies surpassed that of many executives and practitioners. He went on to work for a stem cell company, then founded Liveyon LLC, a distribution company dedicated to bringing cutting-edge stem cell products to physicians and patients nationwide. Eventually, John opened a state-of-the-art laboratory to further advance innovation in cellular medicine.

Liveyon LLC operated under the regulatory framework established as Title 21 C.F.R. 1271, Section 361 of the PHS, which the FDA specifically created to allow Human Cell and Tissue Products (HCT/Ps) such as stem cells to be marketed without pre-market approval, provided certain conditions were met. However, the regulatory guidelines were ambiguous and subject to varying interpretations, leaving much of the industry navigating in good faith under unclear rules.

The charge brought against John was One Count: 21 U.S.C. 331(d), 333(a)(2), and 355(a), 18 U.S.C. 2 INTRODUCING AN UNAPPROVED NEW DRUG INTO INTERSTATE COMMERCE WITH INTENT TO DEFRAUD. The government alleged that the stem cell products distributed by Liveyon LLC did not qualify as HCT/Ps under Section 361 exemption, based on educational, and marketing materials. Although the FDA's framework was intended to foster innovation, the lack of clarity led to differing interpretations across the field. Laboratories, companies, and medical professionals broadly operated under the accepted understanding that these products qualified for the exemption. Despite this, John was charged and convicted under a narrow interpretation that had a significant chilling effect on innovators advancing critical medical science.

John's case represents much more than a single prosecution. It symbolizes the real and growing threat of regulatory overreach stifling American medical innovation. His case has sent a troubling message to others in the field: that leading in regenerative science, even while operating within the spirit and intent of existing FDA guidance, can result in severe prosecutorial consequences. This discourages not only business leaders, but also physicians, scientists, and entrepreneurs from developing new treatments that could offer hope to millions.

John W. Kosolcharoen has nearly completed his sentence, but the damage extends far beyond the time served. He has lost years of contribution to an industry he helped build. More importantly, future patients stand to lose access to the breakthroughs that could arise from regenerative science if innovators are silenced.

We, the undersigned, therefore respectfully urge the President to grant a full pardon to John W. Kosolcharoen to correct a miscarriage of justice, to restore integrity to the oversight of medical innovation, and to ensure that America remains the global leader in advancing life-saving cellular therapies.

By signing this petition, you are standing for:

     Scientific Progress

     Fairness in Justice

     Safe and ethical regenerative medicine

     Restoring integrity in the legal treatment of innovators

Sign. Share. Support. Help us bring justice to John and advance the future of Regenerative Medicine.