FDA approves second Advanced Cell stem cell trial

WASHINGTON Mon Jan 3, 2011 11:34am EST

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WASHINGTON (Reuters) - Advanced Cell Technology 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 loss.

It is the second FDA approved trial for ACT's stem cell product and the third for the controversial and powerful stem cells.

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 stem cells.

"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 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 dystrophy.

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 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 policy.

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)

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Comments (3)
aledute wrote:
Dear Ms. Fox:

I enoyed your article very much, however the following is an inaccurate statement as far as Advanced Cell Technology is concerned:

“Opponents object to their use because to get the cells, someone has to take apart a human embryo.”

Advanced Cell Technology’s method for exctracting human embryonic stem cells is called “Blastomere” and has been recently patented. The method does not, yes it does not destroy or harm an embryo, so no embryos are taken apart by using the Blastome technology. I think that fact should be let known in your article for your readers’ better understanding. Thank you and happy new year.



Jan 03, 2011 12:45pm EST  --  Report as abuse
hacm wrote:

i assume “Blastomere technology” that you’ve mentioned is similar to PGD (Preimplantation Genetic Diagnosis)? if not, please post a link that describe your procedure and its long-term effects on the embryo.

if so, you ought to know that PGD has many side effects, not to mention that embryo can die during PGD procedure. PGD can cause serious long-term side effects on the embryo such as developing dementia, Alzheimers, Down Syndrome, etc. at the adulthood.

do you still claim that “Blastomere technology” does not destroy or harm an embryo?

Jan 03, 2011 3:51pm EST  --  Report as abuse
SO much effort to make embryonic stem cells work when adult stem cells have been treating thousands for years successfully. It defies logic.

Jan 03, 2011 4:21pm EST  --  Report as abuse
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