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October 21, 2010

Regenerative Medicine could get billions of dollars in funding and revenue from stem cell breast augmentation

Stem cell breast augmentation is not a substitute for implants for women who want to look unnaturally large. You can’t take a flat-chested woman and make her look like a dancer at a strip club. We’re not targeting that market. If they don’t care about looking natural, let them do silicone. The goal of this is a natural, soft-tissue feeling. Plus, there is a whole new market of women who would love another 100 to 200 cc but would never have an implant. This market is likely bigger than the current breast implant market—a sea of women who wouldn’t consider a silicone implant but who would be intrigued by the opportunity to have their breasts plumped with cells from their own bodies while reducing the fat in their hips and abdomen to boot.

In late 2007, cosmetic surgeon Tatsuro Kamakura of Cosmetic Surgery Seishin in Japan began a study of the Celution System for breast augmentation, eventually enrolling 20 women. In 2008 he told the Congress of the Japan Society of Aesthetic Surgery that the first three patients kept their new volume and that the tissue remained soft and natural. He had injected an average of 160 cc of stem-cell-loaded fat droplets, boosting breast circumference an average of 4 centimeters (1.6 cup sizes). In commercial use, a new breast could run about $2,000 to $2,800, depending on physician charges. “It’s probably a $1 billion market,” Calhoun says. “You can buy an appliance with a 30 to 40 percent unpleasant rate or you can use your own cells. Which would you choose ?



A clinical trial in Europe in 2008 and 2009, called Restore 2, used the next generation of the Celution machines, also with tantalizing results. It studied women who’d had a partial mastectomy, including Irene MacKenzie, 51, who works for the national health service in Scotland. She was diagnosed with breast cancer six years ago, and after a partial mastectomy was told by her surgeons that reconstruction wasn’t necessary, let alone possible.

MacKenzie had heard about a surgeon, Eva Weiler-Mithoff of the Glasgow Royal Infirmary, who might be able to help. MacKenzie sought her out and in the spring of 2008, Weiler-Mithoff called and told her about the Restore 2 trial, for which she was a lead investigator. MacKenzie signed on. She liked the results but in January 2009 returned to Weiler-Mithoff for another go. “She told me maybe we should have put more cells in, so I went back,” says MacKenzie, who now pronounces herself delighted with her new breast. In December 2009, Weiler-Mithoff told the San Antonio Breast Cancer Symposium that the procedure improved breast deformity in most of the 31 patients who were assessed, with the new breasts holding up for the six to 12 months that the women had been followed. How the new breast felt and moved on the chest wall kept improving. “One of the most striking aspects of the trial was how happy the patients were” with their new breast, says Weiler-Mithoff, who compares the injections to putting in “little pearl strings of fat.” The women, she says, “felt whole again.” MacKenzie’s need for a touch-up, however, shows that not everyone gets the desired results the first time. In fact, all but one of Vranckx’s post-mastectomy patients needed at least two procedures. The Celbrush, after all, is the instrument of an artist. “So far, we’ve been able to repair defects that we couldn’t before,” Vranckx says. “But it can take eight hours to do two breasts—eight hours bringing one droplet after another to the breast. It’s sculpting, and not everyone can be a sculptor.”

Restore 1 showed that Cytori’s cells could rebuild breasts lost to cancer. The next logical step was trying it out for breast augmentation. Perhaps not surprisingly, once again this happened in Japan. The country has a strong and entrenched cultural prejudice against putting anything foreign into one’s body; organ transplants were slow to be adopted in Japan and still remain rare. But if that ick factor is the immovable object, the Western-inspired desire for bigger breasts is the irresistible force.

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