In late 2007, cosmetic surgeon Tatsuro Kamakura of Cosmetic
Surgery Seishin, a chain of surgical clinics in large Japanese
cities such as Tokyo and Osaka, 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 160cc of stem cell- loaded fat droplets, boosting breast
circumference an average of four centimetres (1.6 cup sizes). In
commercial use, a new breast could run to about $2,000 to $2,800
(£1,259 to £1,750). "It's probably a $1 billion market," Calhoun
But the possibilities aren't boundless. "It's not a substitute
for implants for women who want to look, um, unnaturally large,"
Hedrick says. "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 100cc to 200cc but would never have an
implant. I think that's bigger than the current breast-implant
market." That is, women who wouldn't consider a silicone implant
but who would be intrigued by the chance to have their breasts
plumped with cells from their own bodies while reducing the fat in
their hips and abdomen to boot.
Typically, experimental medical treatments go through years of
testing in animals before they reach people. Although
regulators in Europe and Japan were satisfied with the animal and
human studies that Cytori submitted for approval of the Celution
machine, the US Food and Drug Administration has yet to weigh in.
And as women in Japan were being treated with Cytori's cells, the
company was still conducting studies on animals to assess the
safety of the procedure. As recently as 2007, Cytori's principal
scientist, John Fraser, was performing key experiments on mice. The
problem is that the reason adipose regenerative cells work --
inducing the formation of blood vessels -- is also the reason they
might be dangerous, especially to cancer survivors. Such
angiogenesis, after all, is what allows metastatic tumours to
thrive. But Fraser's experiment showed that in mice, the adipose
regenerative cells did not trigger the formation of breast tumours,
promote their growth or cause them to metastasise to the lungs.
The human trials have not followed the women for very long, so
it is still possible that a dangerous side effect like cancer will
emerge. "People do challenge me: 'Why are we moving so fast?'"
Fraser says, standing in a corridor adorned with posters of results
he and his colleagues have presented at conferences. Hedrick jumps
in: "It's because we think like doctors taking care of patients. We
have a lot of doctors working here. When we felt there was clear
sailing, we hit the gas pedal. Where we felt there were obstacles,
we slowed down."
Adds Fraser, "We're not cowboys." They might find themselves in
an industry shoot-out, however, as the allure of adipose-derived
stem cells has drawn other companies to the field. The most
flamboyant is AdiStem, based in Hong Kong. Its process, like
Cytori's, begins with liposuction. The fat is mixed with enzymes
and centrifuged, then the precipitated cells are centrifuged again.
That, however, is where the similarity ends. AdiStem next mixes its
cells with plasma and exposes them to laser light, the company
claims, to photoactivate stem cell functionality. CEO Vasilis
Paspaliaris says the resulting cells can then potentially be used
to treat autism, idiopathic pulmonary fibrosis, osteoarthritis of
the knee and hip, type 2 diabetes, acne scarring and hair loss, as
well as in cosmetic reconstruction.
Although Paspaliaris says all the results seem promising, he
believes "the most convincing" are those for the face. Some Los
Angeles cosmetic surgeons are already using the AdiStem process
with face-lifts. These claims have raised eyebrows. It hasn't
helped that AdiStem posts videos of its autism "treatments" on
YouTube or that there are no peer-reviewed scientific papers on the
use of photoactivation to increase stem-cell functionality. Calhoun
says: "At the right time, we will protect our markets and enforce
our patents, but at present it seems to be a potential waste of
capital, resources and energy."Cytori's bigger concern is that
although these companies may pose no competitive threat, they are a
PR disaster waiting to happen.
There is one other key feature that the next-generation Celution
machine shares with a photocopier, as Calhoun demonstrates. Just as
the latter has a touch screen control panel that displays options
(paper size, number of copies, magnification), so does the Celution
-- only here, the options are organs. "See? There's a picture of a
breast, a heart, a disc in the back," he says.
"You push that and the machine loads different software, which
adds the right drugs," reagents and other biochemicals to the
liposuctioned fat cells. He envisions an iPhone like business
model, with individual doctors devising apps to repair different
organs with the perfect slurry of adipose regenerative cells. If it
works, the breasts on his laptop will have plenty of company.