Judges side with FDA in rejecting stem cell device

WASHINGTON (AP) -- A federal appeals court has sided with the Food and Drug Administration in a case brought by medical device maker Cytori, ruling that the agency was correct to reject fast-track approval for two company devices used to process adult stem cells.

Cytori Therapeutics Inc. makes the Celution and StemSource devices which separate adult stem cells from fat tissue using a combination of spinning motions and chemical reactions. The company is studying the technology for a variety of medical uses, including breast reconstruction, burn healing and treating damaged heart tissue. The technology has even been adopted by some plastic surgeons, who claim adult stem cells can be injected into the face, breast and other areas to create a younger look.

Medical devices cannot be marketed in the U.S. without prior approval by the FDA.

Cytori asked the FDA in 2011 to approve the Celution and StemSource devices using a fast-track pathway reserved for devices that are similar to products already on the market. Cytori argued that its technology is similar to that used to process cells from blood and bone marrow.

The FDA rejected that argument and told the company it would need to apply through a more rigorous process that involves large studies with human participants.

A three-judge panel backed that decision in a ruling issued Friday.

"FDA concluded and explained that fat is not blood and that the difference matters. A court is ill-equipped to second-guess that kind of agency scientific judgment," states the opinion, written by Judge Brett Kavanaugh. "After careful review, we find FDA's assessment both reasonable and reasonably explained."

The ruling was signed by fellow Judges Janice Rogers Brown and David Sentelle of the U.S. Court of Appeals for the District of Columbia.

The judges noted that the study Cytori submitted to the FDA for approval included only 12 patients, too small for regulators to evaluate the safety and effectiveness of the technology.

Cytori downplayed the significance of the ruling Friday in an interview with The Associated Press, saying the company had effectively abandoned the shortcut approval pathway, known as the 510k process.

Judges side with FDA in rejecting stem cell device

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