* Trial in 3rd approved test of human embryonic stem cells
* Company sees multibillion-dollar market
By Maggie Fox, Health and Science Editor
WASHINGTON, Jan 3 Advanced Cell Technology
ACTC.OB said on Monday it had won U.S. Food and Drug
Administration approval to try out human embryonic stem cells
for treating macular degeneration, a common cause of vision
It is the second FDA approved trial for ACT's stem cell
product and the third for the controversial and powerful stem
ACT said it would start recruiting patients with dry
age-related macular degeneration using retinal pigment
epithelial, or RPE cells, which ACT makes from human embryonic
"Dry AMD is the leading cause of blindness in individuals
over the age of 55," Dr. Robert Lanza, ACT's chief scientific
officer, said in a statement.
"As the population ages, the incidence of AMD is expected
to double over the next 20 years," he added.
In October, Geron Corp (GERN.O) enrolled the first patient
in the first ever approved study of human embryonic stem cells,
to treat people whose spinal cords have been crushed.
In November, ACT won FDA approval for the second human
trial of human embryonic stem cells to treat people with a
progressive form of blindness called Stargardt's macular
AMD, a slowly progressing disease, blurs vision at first
but later causes a big black hole in the field of vision.
Wet AMD can be treated with laser surgery, photodynamic
therapy and injections of Roche's ROG.VX drug Lucentis into
the eye. Taking a specific combination of vitamins and zinc can
reduce the risk of dry AMD and perhaps slow its progression.
There are no good treatments for advanced cases of dry AMD,
which causes an estimated 85 percent of cases of macular
degeneration, according to the U.S. National Eye Institute.
ACT estimates dry AMD that is serious enough to treat
affects 10 million to 15 million Americans and sees a potential
global market of $25 billion or more.
The approval "marks a major step forward, not just within
the stem-cell sector, but, potentially for modern healthcare
techniques," Gary Rabin, interim chairman and CEO of ACT, said
in a statement.
Stem cells are the body's master cells, the source of all
other cells. Embryonic stem cells, taken from days-old human
embryos, are especially pliable.
Opponents object to their use because to get the cells,
someone has to take apart a human embryo.
Last year, the Obama administration overturned the
strictest of the limitations on using federal funds for the
research, but last summer, two researchers challenged the
A U.S. appeals court has ruled that funding could continue
while the government appeals, but grants from the National
Institutes of Health have been frozen and unfrozen as various
courts have weighed in and the court battles are continuing.
(Editing by Maureen Bavdek)