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Clinics around the country, including at least two in the Portland area, may be promoting stem-cell-related procedures that aren't approved by the U.S. Food and Drug Administration, according to a new article in the journal Cell Stem Cell.
The new findings, reported by Bloomberg, call into question the safety of certain kinds of stem-cell therapy offered by at least 570 clinics around the U.S.
"The big question for me is, how did this happen in the United States?" said Leigh Turner, an associate professor at the University of Minnesota's Center for Bioethics & School of Public Health, who co-authored the study told Bloomberg. "It's often framed as a story about stem cell tourism, that these businesses don't exist in the United States, they exist elsewhere around the world in Ukraine, Mexico, China, and India. Our findings clearly show that this is a widespread problem here."
Stem-cell therapy utilizes stem cells, or unspecialized cells that can duplicate themselves through cell division, to treat various illnesses and conditions. The FDA has approved some stem cell therapies, such as one that uses stem cells derived from bone marrow to treat immune system and blood diseases.
However, the FDA has still not approved a procedure using stromal vascular fraction cells (SVF)—in which stem cells are taken from a patient's fat tissue and re-injected into the patient—that is being touted as a way to treat everything from baldness to heart disease.
In a statement, FDA spokeswoman Andrea Fischer said the FDA is "concerned that the hope patients have for treatments not yet proven to be safe and effective may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful."
Patients pay out of pocket for stem-cell therapy—some up to $50,000—according to a 2015 article in The New England Journal of Medicine, because the procedures aren't covered by insurance companies. And though the risks are unclear, there have been some alarming results: The New York Times, reported, for instance, that a disabled American named Jim Gass who received stem cell therapy in foreign countries became paralyzed from the neck down when a stem cell mass accumulated in his spinal column.
In Portland, there appear to be two clinics that offer stem cell therapy: The Center for Traditional Medicine in Lake Oswego, and the Core Wellness Clinic in West Portland. According to their websites, both clinics offer types of stem cell therapy not approved by the FDA to relieve joint and ligament-related ailments.
The Core Wellness Clinic declined a request for comment, and the stem cell therapy practitioner at The Center for Traditional Medicine is out of the country.
Correction: This article previously stated that Core Wellness Clinic offers SVF therapy. It does not. WW regrets the error.
Willamette Week