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Home » Embryonic stem cells debut in eye treatment in Advanced Cell Tech’s first human trials | Regulatory Roundup

Embryonic stem cells debut in eye treatment in Advanced Cell Tech’s first human trials | Regulatory Roundup

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ACTC

Advanced Cell Technology Inc. (OTC:ACTC) successfully dosed the first patients in clinical trials of stem cell implantation for blinding eye diseases, making it only the second company in the U.S. to win FDA permission to study a therapy derived from embryonic stem cells.

ACTC’s two trials involve implantation of retinal pigment epithelial cells derived from embryonic stem cells into patients with Stargardt’s macular dystrophy and dry age-related macular degeneration.

The first patient in each trial successfully underwent an outpatient surgery and both are recovering uneventfully, according to the press release.

"This first treatment milestone is welcomed by scientists, stem cell advocates and patients hoping for cures," Gary Rabin, interim chairman & CEO of ACTC, said in prepared remarks. "The two trials could not have started any smoother, and we are very pleased to announce that the procedures went well."

Dry AMD, the most common form of macular degeneration, Stargardt’s and other forms of atrophy-related macular degeneration are usually untreatable, company officials reported, but the trials mark a step forward for embryonic stem cell research as well.

"It’s vindication," ACTC chief scientific officer Robert Lanza told Xconomy. "In the early days, we were called murderers. We almost went under a few times. This was not easy."

ACTC won CE Mark approval in the European Union for its stem cell treatment in March.

Regulatory Roundup
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  • Luminex announces FDA clearance for respiratory test
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  • BG Medicine touts ISO 13485 certification
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  • Biosense Webster enrolls first patients in force sensing catheter trials
    Biosense Webster Inc., a Johnson & Johnson (NYSE:JNJ) company, and a global company in the diagnosis and treatment of cardiac arrhythmias, announced the enrollment of the first patient in a U.S. trial of the Diamond Bar, Calif.-based company’s Thermocool SmartTouch contact force sensing catheter system.
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