Risk Associated with Unapproved Products Derived from Stem Cells, Placenta, and Umbilical Cord Blood

Recent events in our state and others have highlighted the risks to patients treated with unapproved stem cell, placental and umbilical cord blood-derived products. A recent incident involved individuals treated in Nebraska who became ill after receiving a product derived from C-section placentas, a subset of whom became bacteremic. The FDA recently issued a warning regarding unapproved products derived from stem cells.1 Today, the FDA has issued a patient safety notification warning of risks associated with products derived from stem cells and placentas, especially a product termed exosomes.2 These therapies are administered through intravenous injection, inhalation, or injection into joints or soft tissue. Nebraska DHHS continues to actively assess this situation along with our federal partners at the FDA and CDC.

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