Certain types of stem-cell treatment should be regulated as drugs, a US appeals court decided on 4 February. The ruling rejects claims by Regenerative Sciences of Broomfield, Colorado, that its stem-cell therapy, used in orthopaedic applications, is a medical procedure that does not require regulation by the Food and Drug Administration. The court decided that processing the cells for use in the therapy made the end product a drug. The company has not completed clinical trials on the treatment so cannot market the product in the United States. It does sell it in the Cayman Islands (see Nature 488,14; 2012).
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