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Cytori won a $4.7 million Defense 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 gray 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 cooperating as much as possible with the FDA. "Do we have 100 percent 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.
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