ISSCR Urges FDA and EMA to Enforce Regulation of Clinics Offering Unproven and Unapproved Stem Cell-based Interventions
Misleading Marketing Preys on the Hopes of Patients and Families, Including Those with COVID-19
Skokie, IL – In letters released today by the International Society for Stem Cell Research (ISSCR) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the Society presses for greater enforcement to help protect patients suffering from devastating diseases including COVID-19. The effort comes as the world’s foremost stem cell and regenerative medicine researchers are meeting this week to share the field’s newest discoveries as part of ISSCR 2020 Virtual.
Among other key points, the ISSCR urges the regulators to boost enforcement activities with particular attention to businesses seeking to exploit the fear of COVID-19 to market unproven therapies. There have been myriad public claims from companies who are offering cell therapies for COVID-19 that lack any credible basis in science and often ignore good manufacturing practices, which has resulted in some contaminated products.
The ISSCR also stresses that the role of regulators also is critical to protecting patients as experimental new therapies are evaluated in clinical trials. While the Society recognizes that the pandemic has made that mission more challenging, ISSCR reinforces that regulators must continue to insist on robust and sound pre-clinical safety and efficacy data before allowing first-in-human clinical trials for experimental stem cell-based therapies.
The ISSCR is committed to working with regulators to help ensure robust regulation of any stem cell-based therapies and to press for greater enforcement of existing regulations in place to protect the public from unproven treatments and unscrupulous marketing claims.
Letter to FDA and the Letter to EMA.
About the International Society for Stem Cell Research (www.isscr.org)
With nearly 4,000 members from more than 60 countries, the International Society for Stem Cell Research is the preeminent global, cross-disciplinary, science-based organization dedicated to stem cell research and its translation to the clinic. The ISSCR mission is to promote excellence in stem cell science and applications to human health. Additional information about stem cell science is available at A Closer Look at Stem Cells, an initiative of the Society to inform the public about stem cell research and its potential to improve human health.