By an Evidence-Based Cellular Orthopedic Surgeon
The Food and Drug Administration has pledged that after May 31, 2021, the agency will broadly enforce requirements that developers of regenerative medicine products — therapies intended to repair or replace damaged cells, tissues, and organs — follow relevant approval rules for new drugs, medical devices, and biologics. FDA’s increased enforcement comes not a moment too soon as hundreds of businesses continue to sell unapproved — and unproven — regenerative therapies directly to consumers, leading to patient injuries.
New research by The Pew Charitable Trusts underscores the need for aggressive FDA enforcement against such businesses and practices. Pew found that from 2004 to September 2020, at least 360 people were reportedly harmed by regenerative therapies not approved by FDA nor offered through clinical trials. The products involved were often derived from cells taken from patients or donated sources, such as umbilical cord blood and placental tissue.
My findings suggest that FDA’s recent efforts to reduce the marketing of unapproved therapies have been helpful but not adequate to protect patients. In 2017, the agency provided a detailed framework and guidance to help regenerative medicine businesses meet product approval requirements and gave them three years to come into compliance. Officials later extended the deadline to May 31, citing the coronavirus pandemic. Over this period, FDA sent letters to more than 350 companies and individual providers, warning that their products may violate the law, and sought legal injunctions against a handful of clinics. Nevertheless, clinics continue to market unapproved therapies, including exosomes derived from stem cells and platelet-rich plasma, which are marketed as regenerative interventions and considered a blood product by the FDA.
Many patients have shown interest in regenerative medicine’s potential to treat disease and heal injuries, but widespread sales of unproven products threaten patient safety and trust. The FDA must enforce the law to eliminate the marketing of unapproved products and weed out the charlatans, camp followers, and prostitutes; and ensure that developers of cell- and gene-based therapies conduct clinical trials to demonstrate that their interventions are safe and effective. That’s why I elected to participate in the Personalized Stem Cell first of several FDA-approved Clinical Trials for adipose-based stem cells in knee arthritis, Visit www.PersonalizedStemCells.Com. These steps will help FDA more efficiently root out risky products and foster a safer regenerative medicine marketplace for patients.