The ISSCR commends the U.S. District Court ruling that confirms the FDA’s authority to regulate clinics marketing and selling unproven therapies as stem cell products. The clinic, U.S. Stem Cell, has injected cells derived from fat into the eyes of several patients, resulting in at least three being blinded.
The ruling, which upholds FDA legal action against U.S. Stem Cell Clinic and U.S. Stem Inc. is likely to have broad implications as it addresses common practices by stem cell clinics operating without FDA approval. Hundreds of clinics throughout the United States are selling cell therapies to patients that have not been shown to be safe or effective in clinical trials. In many cases, these unproven therapies would not be expected to provide any benefit to patients based on what we understand about the biology. This ruling confirms that U.S. Stem Cell’s processing of stromal vascular fraction (cells from adipose tissue) does not qualify for the “same surgical procedure exception,” and rejects the notion that U.S. Stem Cell’s products qualify for exemptions under the FDA’s rules for homologous use.
“The ruling from the U.S. District Court is welcomed news and will put rogue clinics on notice that they are not above the law,” said Doug Melton, ISSCR President. “FDA now has undisputable authority to close down clinics marketing unproven therapies as stem cell-based interventions. The ISSCR is also delighted with the FDA’s recent commitment to aggressively pursue clinics that prematurely market stem cell therapies have yet to be proven safe and effective.”
The ISSCR has long warned about the proliferation of clinics offering stem cell therapies that have little basis in science or medicine. The society offers advice and scientific expertise to governments and regulatory authorities worldwide as they try to curtail this problem. To learn more about the potential for stem cells to impact human health, visit A Closer Look at Stem Cells.
June 4, 2019