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It should be safety-first on stem cell therapies

A stem cell colony. Oregon Health & Science University/AP/File 2013

As interest in alternative medicines has risen, so has the number of clinics pushing the supposed benefits of stem cell therapies. These businesses say stem cells have the power to help the body repair itself, without surgery or painful side effects. They’re using them to treat everything from cosmetic “flaws” (sagging skin and hair loss) to life-changing ailments (Parkinson’s disease and diabetes). The clinics’ pitches are carefully crafted to hype potentially dramatic results, without running afoul of federal regulators. A “rejuvenation center” in Arizona sells a treatment that will “improve your marriage.” A Florida stem cell company advertises “groundbreaking advances” that give patients “the ability to fight back against diseases once thought untreatable.” And a California outfit claims its customers have reported “higher energy levels, better sleep, and overall improved quality of life.”

It all sounds appealing, maybe even borderline miraculous, but the safety and effectiveness of such services is, at best, questionable. Until now, stem cell clinics have faced only minimal scrutiny from the Food and Drug Administration. Unlike drugs and medical devices, stem cell therapies don’t have to go through the rigorous FDA review and approval process, which includes years of testing in laboratories and patients. Because the cells used by clinics are harvested from and injected into the same patient’s body, clinic operators maintain that their work meets the FDA’s definition of “minimal manipulation of human cells, tissues, and cellular and tissue-based products.” The agency doesn’t agree, and it recently sent warning letters to some clinics, alleging they improperly use stem cells as biologic drugs. But the “minimal manipulation” wording is vague enough to still be interpreted by some as a loophole.


Fortunately, rather than continuing to target individual clinics, the FDA appears poised to take comprehensive action that would strengthen the rules governing stem cell therapies. As reported by STAT, critics in the health care industry have for years complained that unproved stem cell treatments offered by clinics are a waste of money, and possibly dangerous. Paul Knoepfler, a stem cell researcher at the University of California at Davis, told STAT, “It’s a huge, unapproved human experiment.”

The FDA has scheduled a public hearing on April 13 to solicit comments on draft guidelines it released last fall to clarify the use of stem cells. Under those guidelines, most cells would have to meet the same regulatory standards that apply to drugs. That concerns some patient advocacy groups, including the Alliance for the Advancement of Cellular Therapies and Patients for Stem Cells. They worry about approval procedures that could drag on for years, and they say denying patients control over the use of their own cells amounts to a civil-liberties violation. Those concerns deserve consideration, but patients also need to trust that any treatment they seek from a licensed physician or medical center has passed muster with the FDA. When stem cells are used as medicine, they should be regulated as medicine.