Regenerative medicine is a broad field that develops methods to regrow, repair, or replace damaged or diseased cells and tissues. Stem cell products, gene therapies, and other regenerative techniques have the potential to one day cure major diseases and heal traumatic injuries, but to date, only a few have been approved as safe and effective by the Food and Drug Administration (FDA). Unfortunately, this has not stopped hundreds of U.S. businesses from selling unproven—and, in many cases, harmful—treatments for a wide range of health problems.
Pew is working to ensure that FDA protects public health and safely fosters the growth of this emerging field by implementing and enforcing the agency’s regulations for regenerative medicine.
Stem cell products and other regenerative therapies have significant potential to treat traumatic injuries and serious diseases. Although some have earned approval from the Food and Drug Administration, most have not, and many of these unapproved interventions have led to life-threatening infections, chronic pain, and even death.
The Food and Drug Administration and members of Congress have taken important steps in recent months to protect consumers from unproven and risky stem cell products offered by hundreds of clinics nationwide. However, the agency needs to take broader action to deter businesses from selling interventions whose safety and effectiveness have not been proven to regulators.
Over the last two decades, cell therapies (which involve the transplantation of whole cells into a patient), gene therapies (which use genetic material to manipulate a patient’s cells), and other medical treatments intended to repair or replace damaged, diseased, or dysfunctional cells, tissues, and organs have generated increasing public interest.
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