January 3, 2011
US Company Given Go-Ahead for Stem Cell Research
US biotech company Advanced Cell Technology (ACT) said on Monday that it was cleared by the government to start its second trial using human embryonic stem cells to treat blindness.
The trial will examine the therapy's ability to safely treat people with a condition known as dry age-related macular degeneration, which is the most common form of irreversible vision loss in people over the age of 60.
The company said that there is currently no cure for the disease, which affects around 10 to 15 million Americans and another 10 million people in Europe.
The Food and Drug Administration (FDA) cleared the Massachusetts-based company in November to begin a similar trial on patients with a progressive form of juvenile vision loss, which is known as Stargardt's disease.
"ACT is now the first company to receive FDA clearance for two HESC (human embryonic stem cell) trials, and is now a true translational leader in the field of regenerative medicine," Gary Rabin, Interim chairman and chief executive, said in a statement on the company's website.
"It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques."
The company hopes to start the U.S. clinical trials in the coming months, and intends to seek approval for similar trials in Europe. It said the U.S. and European markets for a treatment like this amounts to $25 to $30 billion.
ACT's announcement marks the third trial like this after U.S. company Geron Corp broke new ground last year with the first-ever attempt to use embryonic stem cell therapy on a human patient with spinal cord injury.
Embryonic stem cell research has been a controversial field ever since the first stem cells were isolated over 12 years ago. Critics oppose the research because it involves the destruction of human embryos.
However, scientists said that the cells offer great promise in treating Parkinson's disease, diabetes and a variety of other diseases.
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