Regenerative medicine is an emerging field that is focused on replacing tissue or organs that have been damaged by disease, trauma, or aging as opposed to more conventional medicine that focuses primarily on treating the symptoms of disease.
As you might imagine, regenerative medicine has led to some amazing breakthroughs and therapies – but it also has lead to a lot of experimentation and use of unapproved products that are being sold directly to consumers with the promise of “Fountain of Youth”-like rejuvenation. Some of these have merit, but others are no more than modern-day “snake oil” that can be dangerous, even deadly.
As of June 1, 2021, the Food and Drug Administration (FDA) has pledged that it will start to broadly enforce requirements that developers of regenerative medicine products follow the same approval rules for new drugs, medical devices, and biologics.
New research by The Pew Charitable Trusts underscores the need for aggressive FDA enforcement against such businesses and for the agency to monitor online consumer reviews for signs of potentially dangerous products that need investigation. 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. Individuals suffered injuries including life-threatening infections, blindness, cardiac arrest, and the growth of tumors and lesions. In at least 21 cases, patients died.
A lot of these less than scrupulous sellers of these products have recently added COVID-19 to the long list of diseases and health problems that they allege their regenerative products can treat. Such marketing often lures very sick and desperate patients to try costly therapies that haven’t been proven effective but can lead to serious and even fatal consequences.
Many consumers have shown interest in regenerative medicine’s potential to treat disease and heal injuries, but widespread sales of unproven products threaten not only patient safety but the legitimacy of this emerging field which does offer a number of approved and amazingly effective therapies.
The researchers with The Pew Charitable Trust say that the FDA must enforce the law to eliminate the marketing of unapproved products and ensure that developers of cell- and gene-based therapies conduct clinical trials to demonstrate that their interventions are safe and effective.
Steps like these will help FDA more efficiently root out risky products and foster a safer regenerative medicine marketplace for patients based on sound, evidence-based practices.