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Decision on Stem Cell Therapeutic

The US District Court of Appeals for the DC Circuit ruled this week that the Food and Drug Administration can regulate stem cells as drugs, reports Regulatory Focus. The ruling upholds a lower court decision from 2012.

The case stems from FDA's 2008 warning letter to Regenerative Sciences, in which the agency contended that the company was in violation of federal regulations. Regenerative Sciences was using patients' mesenchymal stem cells as part of its Regenexx procedure to treat arthritis and related injuries, The Scientist notes.

According to Regulatory Focus, FDA argued that the company, now known as Regenexx, did more than "minimal manipulation" to the cells and thus the product had to be regulated as a drug. The company, meanwhile, said that FDA could regulate drugs but not the practice of medicine, which includes procedures like Regenexx.

The circuit court judge, though, sided with FDA. The process "alters the MSCs' relevant biological characteristics and is therefore more than minimal manipulation," Judge Thomas Griffith says in his decision.

Regulatory Focus notes that Regenexx does not plan to appeal the decision to the Supreme Court.