US approves new trial of embryonic stem cells on blindness
Tuesday 04 January 2011
US biotech company Advanced Cell Technology said Monday it was cleared by the government to start its second trial using human embryonic stem cells to treat blindness, this time in older people.
The trial will examine the therapy's ability to safely treat people with a condition known as dry age-related macular degeneration, the most common form of irreversible vision loss in people over age 60.
There is currently no cure for the disease, which affects around 10-15 million Americans and another 10 million people in Europe, the company said.
The Food and Drug Administration cleared the Massachusetts-based company in November to begin a similar trial on patients with a progressive form of juvenile vision loss, 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," said chief executive Gary Rabin.
"It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques."
The company hopes to begin the US clinical trials in the coming months, and intends to seek approval for similar trials in Europe. The US and European market for such a treatment amounts to 25 to 30 billion dollars, it said.
ACT's announcement marks the third such trial, after US company Geron 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 such stem cells were isolated more than 12 years ago. Critics oppose the research because it involves the destruction of human embryos.
However scientists say the cells offer great promise in treating Parkinson's disease, diabetes and a variety of other illnesses.
Like the other trials involving human patients, the first step in ACT's Phase I and II trials is to assess whether the therapy is safe before moving on to testing how well it works.
"In a rat model of macular degeneration, we have seen a remarkable improvement in visual performance over untreated animals, without any adverse effects," said Bob Lanza, chief scientist at ACT.
Twelve patients will enroll in the study at various US sites including the University of California, Los Angeles (UCLA) and Stanford University.
The therapy uses retinal pigment epithelial (RPE) cells derived from human embryonic stem cells to replace RPE cells that have broken down in patients with the disease.
Dry age-related macular degeneration, the type that occurs in 90 percent of cases, causes a deterioration in central vision when RPE cells in the patient's macula, in the center of the retina, lose their ability to function.
Patients often experience blurring in the center of their field of vision, while peripheral view remains intact.
"As the population ages, the incidence of AMD is expected to double over the next 20 years, further exacerbating this unmet medical need," Lanza said.
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