"This week the FDA approved the second human clinical trial of embryonic stem cells. Advanced Cell Technology, one of the few companies which is working with hESCs, plans to treat 12 patients who have Stargardt's Macular Dystrophy, a rare degenerative disease which leads inexorably to blindness. The company foresees a possible US$25 billion-$30 billion global market - if the experiment succeeds.
After nearly 10 years of debate over the ethical and safety aspects of human embryonic stem cell treatments, the FDA has only approved two trials. In the meantime, as we report in this week's newsletter, induced pluripotent stem cells - which have almost none of the ethical baggage of embryonic stem cells -- are showing immense promise. Harvard's Kevin Eggan told Science, 'it's hard not to be pretty pleased with the progress that's been made in a few short years.'
It makes me, at any rate, wonder what exactly is the point of persisting with embryonic stem cells. Many leading stem cell scientists have abandoned hESCs and are working on iPS cells. Could it be intellectual inertia, an inability to change tracks in the light of new knowledge? Is it easier to raise finance for the glamorous and controversial embryonic stem cells?"
By Michael Cook
Editor
Second trial with embryonic stem cells
"The US government has approved a second clinical trial of a treatment using human embryonic stem cells to cure a rare disease that causes serious vision loss. Advanced Cell Technology, a Santa Monica-based biotechnology company, said the research is set to begin next year, after it was approved by the US Food and Drug Administration. Another biotech company, Geron Corp, started a clinical trial for spinal cord injury with hESCs.
ACT's test will focus on Stargardt disease, which affects just 30,000 Americans. The company hopes the same approach will work for similar and more common eye disorders such as age-related macular degeneration, which impacts the lives of millions. Stargardt is an inherited disorder typically beginning in adolescence that attacks central vision which is used for tasks like recognising faces. Some Stargardt sufferers go completely blind or lose all peripheral vision. Others are severely impaired and can only detect light or see their hands moving in front of their eyes.
The key problem with Stargardt is that impaired scavenger cells fail to remove toxic byroducts from the eye, allowing them to accumulate, killing other cells. No proven treatment exists. In ACT's new study, 12 patients will be treated with healthy scavenger cells, created in a laboratory from hESCs. This preliminary phase of treatment is for testing the safety of various doses, injecting just one eye on each patient. 'We're also hoping to see some improvement in visual acuity, but that's a bonus,' Dr. Robert Lanza, ACT's chief scientific officer, said Monday."
By Jared Yee, Nov. 26, BioEdge
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