U.S. Stem Cell

About U.S. Stem Cell

U.S. Stem Cell, Inc., formerly known as Bioheart Inc., is a biotechnology company established in 1999 focused on developing and commercializing autologous cell therapies. The company's business model included developing proprietary cell therapy products, providing training services for physicians in regenerative medicine, selling cell collection and treatment kits for both humans and animals, and operating cell therapy clinics. Its main product candidates included AdipoCell™, a kit for isolating stem cells from a patient's own fat tissue, and MyoCell, a therapy designed to use a patient's muscle cells to improve cardiac function after a heart attack.

The company's leadership included President & CEO Mike Tomas, who had a background in telecommunications and private equity, and Chief Scientific Officer Kristin Comella, who had extensive experience in regenerative medicine and product development. Historically, the company reported completing more clinical treatments than other regenerative care providers and certified over 700 physicians worldwide in its protocols.

A significant turning point for the company occurred in May 2018, when the U.S. Department of Justice, at the request of the Food and Drug Administration (FDA), filed a lawsuit against U.S. Stem Cell. The FDA had issued a warning letter in 2017, citing the company for marketing unapproved stem cell products and deviating from manufacturing best practices. The lawsuit alleged the company was marketing its Stromal Vascular Fraction (SVF) product as a treatment for serious conditions like Parkinson's disease and spinal cord injuries without FDA approval. In June 2019, a federal court ruled in favor of the FDA, granting a permanent injunction to stop the company from manufacturing and distributing its SVF products until it complied with the law. The court determined that the SVF product was a drug that had been adulterated and misbranded. The company appealed the decision but ultimately lost the appeal in the Eleventh Circuit court in 2021. Following the initial court loss, Kristin Comella resigned from her position as Chief Scientific Officer and board member in September 2019.