Policy Memo: ​Stem the Tide of Predatory Stem Cell Clinics: State and FDA Coordination to Protect Patients

…the allure of profits from stem cell therapies have sparked a growing
industry of DTC clinics that advertise and provide non-FDA approved therapies

Griffin McCutcheon (1,2,3), John F. Malloy (1,4), Caitlyn A. Hall (1,5), Cassandra Barrett (1,6)

  1. Arizona Science Policy Network
  2. Arizona State University, School for Engineering of Matter, Transport, and Energy, Tempe AZ
  3. Arizona State University, School for Health and Biological Systems Engineering, Tempe AZ
  4. Arizona State University, School of Earth and Space Exploration, Tempe AZ
  5. Arizona State University, Sustainable Engineering and the Built Environment, Tempe AZ
  6. University of Utah, Eccles Institute of Human Genetics, Salt Lake City, UT

Executive Summary: While stem cell therapies hold promise as regenerative treatments for combating a variety of conditions, the majority of these therapies remain in clinical trials without sufficient evidence for current clinical use. Predatory direct-to-consumer stem cell clinics (hereafter, DTC clinics), undeterred by a lack of clinical evidence, continue to offer unapproved stem cell injections to patients desperate to treat chronic conditions. These clinics can pose significant physical and financial harm to patients as their therapies are not without risks. Clinics rarely practice the requisite level of follow-up care required by clinical trials. To promote the safety and well-being of patients treated in stem cell clinics, we propose additional funding to support the Federal Food and Drug Administration (FDA) and state-level health departments’ oversight of DTC clinics. The FDA will likely experience a substantial financial burden from enforcing regulations, given that there are hundreds of DTC clinics in the U.S. This number is expected to continue rising, as evidenced by a 114% increase in DTC clinics between 2015 and 2017 (P. S. Knoepfler 2019). We propose that the FDA appropriate additional funding to support state level government enforcement and address this impending shortcoming. Additionally, we suggest state legislatures enact registry laws to prevent DTC clinics from avoiding federal regulations and enable local governments to address low-risk offenders as needed. These laws would enable states to take a more proactive role in patient protections, while also allowing the FDA to more effectively target its resources towards high-risk DTC business. 

Read the full article here at the Journal of Science Policy and Governance

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