The US Food and Drug Administration (FDA) has issued a warning against unregulated stem cell therapeutics.
In a statement, the regulator reminded the public to avoid any stem cell treatment that was not approved or under officially sanctioned investigation, noting that only one product (Hemacord, a cord-blood based treatment for disorders of blood cell formation) has been approved thus far. The FDA is stepping up action to clamp down on illegal stem cell treatments; Special Agent in Charge Patrick J. Holland said that such providers “offer false hope to people with incurable diseases in order to line their own pockets”.
Meanwhile the Chinese government is also taking a tough line, ordering the cessation of all unapproved stem cell treatments and clinical trials as part of a new year-long programme to improve regulation of this burgeoning sector. The Ministry of Health has said that charging patients fees for experimental stem cell applications is no longer acceptable, and has suspended new applications for stem cell programmes until July.
Comment: Stem cell treatments – including for overseas patients – has been an area of rapid growth for China and other countries such as India and Russia; whether they will follow China’s lead in exerting greater control over such activities remains to be seen. These moves will certainly be well received by the international stem cell community, where worries over the impact of unproven and unregulated treatments are mounting.