Nature Medicine | Spoonful of Medicine

Court ruling: FDA can regulate stem cell clinics

Cross posted from the Nature News blog on behalf of Monya Baker.

The FDA can block U.S. clinics that offer cultured cell products, according to a ruling of a U.S. district court this week.

Though championed by politicians like Governor of Texas Rick Perry, clinics marketing stem-cell procedures worry many healthcare advocates because these procedures are often heavily marketed but not thoroughly tested in clinical trials. (See Stem cell therapy takes off in Texas from 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.

Read more on the Nature News blog.


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