Journal of Science Policy & Governance | Volume 17, Issue 01 | September 30, 2020

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

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
Download PDF
https://doi.org/10.38126/JSPG170114
Keywords: stem cell, public health, FDA, state regulation, medicine
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 through download.-
Download PDF

References

  1. Berger, Israel, Amina Ahmad, Akhil Bansal, Tanvir Kapoor, Douglas Sipp, and John E. J. Rasko. 2016. “Global Distribution of Businesses Marketing Stem Cell-Based Interventions.” Cell Stem Cell 19 (2): 158–62. https://doi.org/10.1016/j.stem.2016.07.015.
  2. Center for Biologics Evaluation, and Research. 2019. “Approved Cellular and Gene Therapy Products.” U.S. Food and Drug Administration. 2019. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.
  3. Ehrmeyer, Sharon S., and Ronald H. Laessig. 2004. “Has Compliance with CLIA Requirements Really Improved Quality in US Clinical Laboratories?” Clinica Chimica Acta; International Journal of Clinical Chemistry 346 (1): 37–43. https://doi.org/10.1016/j.cccn.2003.12.033.
  4. “FDA’s Framework for Regulating Regenerative Medicine Will Improve Oversight.” n.d. Accessed April 13, 2020. https://www.pewtrusts.org/en/research-andanalysis/reports/2019/10/17/fdas-framework-for-regulating-regenerative-medicine-will-improve-oversight .
  5. Fink, Donald W., Jr. 2009. “FDA Regulation of Stem Cell–Based Products.” Science 324. https://doi.org/10.1126/science.1173712
  6. Frow, Emma K., David A. Brafman, Anna Muldoon, Logan Krum, Paige Williams, Bryson Becker, John P. Nelson, and Ashley Pritchett. 2019. “Characterizing Direct-to-Consumer Stem Cell Businesses in the Southwest United States.” Stem Cell Reports 13 (2): 247–53. https://doi.org/10.1016/j.stemcr.2019.07.001.
  7. Gostin, Lawrence O., Scott Burris, and Zita Lazzarini. "The Law and the Public's Health: A Study of Infectious Disease Law in the United States." Columbia Law Review 99, no. 1 (1999): 59-128. Accessed August 18, 2020. https://doi:10.2307/1123597.
  8. Institute of Medicine (US) Committee for the Study of the Future of Public Health. The Future of Public Health. Washington (DC): National Academies Press (US); 1988. https://doi: 10.17226/1091
  9. Kimbrel, Erin A., and Robert Lanza. 2020. “Next-Generation Stem Cells—ushering in a New Era of Cell-Based Therapies.” Nature Reviews. Drug Discovery, 1–17. https://doi.org/10.1038/s41573-020-0064-x
  10. Knoepfler, Paul. 2015. “David Brafman Guest Post: A Look Inside a Stem Cell Clinic Infomercial Event - The Niche.” The Niche. April 29, 2015. https://ipscell.com/2015/04/lunginstitute/.
  11. Knoepfler, Paul. 2019. “How Much Is Stem Cell Therapy? 2019 Cost Poll Results - The Niche.” The Niche. October 13, 2019. https://ipscell.com/2019/10/how-much-is-stem-cell-therapy-2019-cost-poll-results/.
  12. Knoepfler, Paul S. 2019. “Rapid Change of a Cohort of 570 Unproven Stem Cell Clinics in the USA over 3 Years.” Regenerative Medicine 14 (8): 735–40. https://doi.org/10.2217/rme-2019-0064.
  13. Kuriyan, Ajay E., Thomas A. Albini, Justin H. Townsend, Marianeli Rodriguez, Hemang K. Pandya, Robert E. Leonard, M. Brandon Parrott, Philip J. Rosenfeld, Harry W. Flynn, and Jeffrey L. Goldberg. 2017. “Vision Loss after Intravitreal Injection of Autologous ‘Stem Cells’ for AMD.” The New England Journal of Medicine 376 (11): 1047–53. https://doi.org/10.1056/NEJMoa1609583.
  14. Office of the Commissioner. 2018. “FDA Sends Warning to Company for Marketing Dangerous Unapproved Stem Cell Products That Put Patients at Risk and Puts Other Stem Cell Firms, Providers on Notice.” U.S. Food and Drug Administration. 2018. https://www.fda.gov/news-events/press-announcements/fda-sends-warning-company-marketing-dangerous-unapproved-stem-cell-products-put-patients-risk-and.
  15. Office of the Commissioner. 2019a. “Statement on Stem Cell Clinic Permanent Injunction and FDA’s Ongoing Efforts to Protect Patients from Risks of Unapproved Products.” U.S. Food and Drug Administration. 2019. https://www.fda.gov/news-events/press-announcements/statement-stem-cell-clinic-permanent-injunction-and-fdas-ongoing-efforts-protect-patients-risks.
  16. Office of the Commissioner. 2019b. “FDA Warns About Stem Cell Therapies.” U.S. Food and Drug Administration. April 9, 2019. https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies.
  17. “Senate Bill 512 (2020) - The Florida Senate.” n.d. Accessed April 13, 2020.  https://www.flsenate.gov/Session/Bill/2020/512/
  18. Snyder, Jeremy, Leigh Turner, and Valorie A. Crooks. 2018. “Crowdfunding for Unproven Stem Cell-Based Interventions.” JAMA: The Journal of the American Medical Association 319 (18): 1935–36. https://doi.org/10.1001/jama.2018.3057.
  19. Federal Trade Commission. 2018. “FTC Stops Deceptive Health Claims by a Stem Cell Therapy Clinic”. October 18, 2018. Accessed July 17 2020. https://www.ftc.gov/news-events/press-releases/2018/10/ftc-stops-deceptive-health-claims-stem-cell-therapy-clinic.
  20. U.S. Food and Drug Administration, “FDA in Brief: FDA Launches New Campaign to Advance Ongoing Efforts to Recruit and Retain a World-Class Workforce Dedicated to Protecting and Promoting the Public Health,” news release, July 24, 2018, https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm614567.htm.
  21. U.S. Food and Drug Administration, “FDA 21st Century Cures Workforce Planning Report to Congress” (2018).
Griffin McCutcheon (he/his) is a Ph.D. candidate in the Biological Design Program at Arizona State University. He designs genetic control systems and studies how they can be integrated with biological self-assembly for new methods of nanoparticle fabrication. He is also co-chair of the Arizona Science Policy Network, helping students find their voice and craft values-based policy that leverages their scientific expertise. He enjoys mountain biking the desert trails, woodworking, and being a dog dad to his two pups.
 
John F. Malloy (he/him) is a Ph.D. candidate studying Astrobiology and Complex Systems Science at Arizona State University in the School of Earth and Space Exploration. He studies the fundamental nature and definition of life, both on Earth and on other planets, through exploring the evolution of life and life-like systems. He is working to predict future evolutionary steps and create a universal definition of evolution. He is also a member of the Arizona Science Policy Network, where he works to advance science-based policy measures in Arizona. He enjoys training for and competing in ultramarathons across the American Southwest.
 
Caitlyn A. Hall (she/her/they/them) is a founding member of the Arizona Science Policy Network and a Ph.D. student in Environmental Engineering at Arizona State University. Her current research promotes climate change and natural hazard resilience in communities using microbes to reduce damage from earthquake-induced liquefaction. She works with industry, community, and government leaders to develop best-fit technical, policy, and public health solutions to best-address a community’s challenges and values. Her other research has focused on soil and water remediation, and sustainable use of resources for urban and greenhouse crop production and agriculture. For fun, Caitlyn spends her time rock climbing and trail running.
 
Dr. Cassandra Barrett (she/her/they/them) is a founding member of the Arizona Science Policy Network and holds a Ph.D. in Biological Design from Arizona State University. She is currently retraining as a genetic counselor at the University of Utah to help integrate patient needs into innovation pipelines. Her research is focused on gene therapy implementation and developing best practices for centering patient perspectives within technology development. She is committed to the ethical advancement of genetic medicines and testing through engagement, communication, and innovation. Cassandra is an avid baker, print maker, and poet.
 
Acknowledgements
We would like to thank Dr. Nicholas Weller for his review and feedback during the drafting of this memo.
 
Disclaimer
This memo represents the views and assessments of the authors, not the views of their affiliates, departments, or institutions.
DISCLAIMER: The findings and conclusions published herein are solely attributed to the author and not necessarily endorsed or adopted by the Journal of Science Policy and Governance. Articles are distributed in compliance with copyright and trademark agreements.

ISSN 2372-2193
© 2022 Journal of Science Policy & Governance, Inc. All rights reserved. The opinions, findings and conclusions from JSPG publications, additional article commentaries and related events do not necessarily reflect the views of the journal.