Biotech company Advanced Cell Technology said Monday it received U.S. Food and Drug Administration clearance for clinical trials using embryonic stem cells to treat blindness in elderly people.

ACT is the first company to receive FDA clearance for two human embryonic stem cell trials, according to the company. "It marks a major step forward, not just within the stem cell sector, but, potential for modern health care techniques," Gary Rabin, the company's interim chairman and CEO, said in prepared remarks.

The trial will focus on treating dry age-related macular degeneration, the most common form of vision loss among people over 60 years of age, which currently has no treatment options. Dry AMD affects between 10 and 15 million Americans, according to the company.

In dry AMD, the retinal pigment epithelial (RPE) cells breakdown or become thinner in a patient's macula, the region in the retina that accounts for high acuity vision. The breakdown of RPE cells over time, along with the loss of photoreceptors, can lead to severe vision loss and blindness.

The Marlborough, Mass.-ACT's dry AMD treatment program uses RPE cells derived from human embryonic cells to replace lost RPE cells in patients' eyes.

The initial portion of the trials will focus on the safety of the therapeutic program. In the future, ACT hopes to show that RPE cells that are injected in the retinal space will be capable of slowing down or stopping the progression of dry AMD and potentially restoring some vision to patients, according to the company.

The Phase I/II trial will be a prospective, open-label study involving 12 patients at multiple clinical sites. The Jules Stein Eye Institute at UCLA and the Ophthalmology Department at Stanford University School of Medicine are currently being considered as clinical sites, according to the company.

As the world's population ages, AMD is projected to double over the next 20 years, said Dr. Robert Lanza, ACT's chief scientific officer in prepared remarks. ACT, which uses 50,000 to 200,000 cells to treat each patient, said the treatment has shown promising results among animal studies. "In a rat model of macular degeneration, we have seen a remarkable improvement in visual performance over untreated animals, without any adverse effects," said Lanza. "We have also maintained near-normal function in a mouse model of Stargardt's Disease, a form of juvenile macular degeneration."

According to ACT, more than 10 million Europeans also suffer from the disease, presenting a lucrative market opportunity for the company. "We are moving ahead aggressively to seek regulatory clearance from the European Medicines Agency to conduct clinical trials in Europe," Edmund Mickunas, the company's VP of regulatory affairs, said in a statement.

In Monday afternoon trading, ATC's stock sold for $0.21 per share, up from the previous closing price of $0.16.

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