The American biotechnology company Advanced Cell Technology said Monday it received government approval to start second test human embryonic stem cells to treat blindness-for-maculopathy in the elderly.
The paper will examine the possibilities for this therapy to safely treat people with macular degeneration related to age, which is the most common form of irreversible vision loss among people over 60 years.
There is currently no cure for this disease that affects between 10 and 15 million Americans and 10 million people in Europe, the company said.
The U.S. Agency for control of drugs, the FDA had already approved in November this firm based in Massachusetts (northeast) to initiate similar tests but to treat Stargardt's disease, a childhood disease and less common causes loss vision.
"ACT is the first company to receive FDA approval for two trials with human embryonic stem cells, and is now transnational leader in the field of regenerative medicine," said CEO Gary Rabin.
"It's a breakthrough, not only in the field of stem cells, but, potentially, to the modern techniques of health care," he said.
The company expects to begin clinical trials in the U.S. in the coming months and ask for authorization to perform similar tests in Europe.
"We are moving aggressively to have the authorization of the European medicines agency, to conduct clinical trials in Europe," said Edmund Mickunas, vice president of regulatory affairs ACT.
These tests announced by ACT will be the third of its kind-on embryonic stem cells in human patients, after the U.S. company Geron open the road in October last year, the first attempt to use this therapy in human patients with lesions the spine.
The embryonic stem cell research field has been controversial since the first attempt to isolate these cells for over 12 years. Critics oppose the research because it involves destroying human embryos.
Scientists, however, considered that these cells hold great promise in the treatment of Parkinson's disease, diabetes and other diseases.
Like other experiments involving human patients, the first step in testing phase I and phase II of ACT is to assess whether the therapy is safe, before moving on to test how well it works.
Bob Lanza, ACT's chief scientist, said the trials of this technique in animals showed no evidence of complications or tumors.
"In a model of macular degeneration in rats, we saw a marked improvement in visual performance compared to animals that were not treated, without any adverse effect," said Lanza.
Twelve patients were enrolled in the study at various U.S. sites, including the University of California, University of Los Angeles (UCLA) and Stanford University.
Therapy using retinal pigment epithelial cells (RPE) derived from human embryonic stem cells to replace RPE cells have been destroyed in patients with this disease.
Dry macular degeneration related to age, occurring in 90% of cases, cause a deterioration of central vision when RPE cells in patients with macular lose their ability to function.
Patients experience blurring in the center of your field of vision while peripheral vision remains intact.
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