Health officials issue safety alert on unapproved stem cell products after Nebraska outbreak
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Officials from the Nebraska Department of Health and Human Services have issued a public health advisory following multiple reports of serious adverse events in patients who were treated with unapproved stem cell products, particularly those marketed as containing exosomes.
“This isn’t unique to Nebraska,” Maureen R. Tierney, MD, MSc, health care-associated infections coordinator in the Nebraska Department of Health and Human Services, said in a press release. “People in several other states have also experienced illness after receiving these types of unapproved products. We continue to carefully and actively assess this situation along with our federal partners.”
The Nebraska Department of Health and Human Services reported that the recent outbreak involved fewer than five cases among individuals treated in Nebraska “who became ill after receiving a product derived from C-section placentas, a subset of whom became bacteremic.”
Alerted to this outbreak by the CDC, the FDA has issued its own public safety notification, warning health care providers and consumers to report any ill effects related to the use of exosome products to the MedWatch Adverse Event Reporting program.
“Certain clinics across the country, including some that manufacture or market violative ‘stem cell’ products, are now also offering exosome products to patients,” the FDA noted in its safety alert. “They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions.”
According to the FDA, “The clinics currently offering these products outside of FDA’s review process are taking advantage of patients and flouting federal statutes and FDA regulations. This ultimately puts at risk the very patients that these clinics claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment options, or worse, posing harm to patients, as evidenced by these recent reports of adverse events.”
In the United States alone, there are nearly 600 stem cell clinics advertising interventions to treat a wide variety of conditions, ranging from Parkinson’s disease to macular degeneration to orthopedic injuries. In particular, the promise of stem cell injections offering joint pain relief or even the slim possibility of avoiding more invasive surgeries has resonated heavily among patients with arthritis. While hope runs high among patients with arthritis, and their doctors, current evidence does not support most stem cell treatments for these patient populations.