Appeals court backs FDA in rejecting fast-track approval for Cytori's stem cell devices

WASHINGTON – 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.

“What you’re really seeing today is an old story in some ways, because our pathway to a 510k had effectively been removed from peoples’ consciousness several years ago when we were getting these rejections,” said Mark Saad, the company’s chief financial officer. “This is a final adjudication of that.”

Saad said that Cytori has already begun enrolling patients in a larger trial that will be used to seek traditional FDA approval. The study is looking at stem cell injections to treat heart disease, but approval for that use is not expected until about 2017, according to Saad. It usually takes companies several years and millions of dollars to conduct large studies of medical devices.

Shares of San Diego-based Cytori Therapeutics Inc. fell 5 cents, or 1.8 per cent, to $2.72 in afternoon trading.

Adult stem cells are found in bone, fat and tissue throughout the body and are thought to be able to morph into several different cell types. They differ from embryonic stem cells, whose use has been heatedly debated because their use involves the destruction of human embryos.

Cytori won a $4.7 million Defence Department contract last September to study the use of fat-derived stem cells in treating thermal burns and radiation injuries. The company’s technology is already approved in Europe for several uses, including breast reconstruction in patients who have had cancerous tumors removed.

Cytori stresses that it does not market its products in the U.S. for use in stem cell procedures. However, the company has previously sold its $100,000 devices to plastic surgeons across the U.S. for use as “laboratory equipment” for research, a grey area which is not overseen by the FDA.

Surgeons in Los Angeles, Miami and elsewhere claim to have used Cytori-processed cells to perform “stem cell facelifts,” which they market as an alternative to the incisions and implants of traditional plastic surgery. But there are few studies to support such claims, and the FDA has not approved any therapies using stem cells for cosmetic use.

Saad said Cytori is not responsible for how researchers use the device and that the company is co-operating as much as possible with the FDA.

“Do we have 100 per cent control over what third party doctors do with things they find? Of course not,” Saad said. “People have the ability, under the practice of medicine, to do a variety of things and it’s up to their medical boards to review them.”

When asked if the Cytori continues to sell its devices to doctors for research use Saad said: “We are not promoting it to researchers in the U.S. That’s the cleanest and tightest way to say it.”

Last year the two largest professional societies for plastic surgeons issued a joint statement calling on their members to avoid stem cell procedures. A review of the medical literature found little human data to support the benefits of injecting stem cells into patients, according to the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery.

“The public needs to understand that while there is a scientific basis for this, it’s just too early to say it’s an effective treatment in humans,” said Dr. Peter Rubin of the University of Pittsburgh in an interview with the Associated Press at the time of the statement’s release. Rubin headed the task force that reviewed the evidence on stem cell therapies.