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Court ruling: FDA can regulate stem-cell clinics

The US Food and Drug Administration (FDA) can block US clinics that offer cultured cell products, according to a ruling of a US district court this week.

Although championed by politicians such as Texas governor Rick Perry, clinics marketing stem-cell procedures worry many health-care advocates, because these procedures are often not thoroughly tested in clinical trials (see Nature‘s ‘Stem-cell therapy takes off in Texas’ and warnings compiled by the International Society for Stem Cell Research).

If cells are harvested and returned to a patient with ‘minimal manipulation’, the procedures are not regulated, but further processing classifies cell treatments as a drug, which requires FDA approval.

Legal action in the recent court decision began in 2008, when the FDA moved against Regenerative Sciences, based in Broomfield, Colorado, which offered to treat joint and other problems by collecting patients’ stem cells, then sorting, culturing and re-injecting them.

The medical director of Regenerative Sciences challenged the FDA, maintaining that the treatment is not subject to FDA regulation because it uses a patient’s own cells.

However, a court ruled on Monday that the clinic’s product was a drug and granted the FDA’s request for a permanent injunction against the company. Presumably, the ruling paves the way for further crack-downs. Alternately, it may cause more stem-cell tourism, in which desperate US patients seek treatment abroad, in clinics with even less regulation.


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    Barbara Hanson said:

    At the very least this ruling will cause more stem cell tourism. It will also cost many people their lives who could benefit from treatment with their own stem cells. I have a terminal lung condition. I have had stem cell therapy using my own stem cells and my lung function has improved and I feel better than I have in years. This ruling does not protect patients. It protects the self interests of an industry that is salivating to cash in on the billions of dollars that can be made from patents, research and off the shelf stem cell products. There is no money in a patient’s own stem cells and this is all about the money. This fight isn’t over yet. This type of treatment should be the practice of medicine. Patients are protected because doctors are licensed by the states in which they practice and they must carry malpractice insurance. Those in the industry that are celebrating this ruling should know that patients are devastated by it. It’s time that patients whose own stem cells are the subject of this regulatory action were listened to. We have had enough “protection”. It’s time to give us our freedom.

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