Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of an additional patient in its Phase 1/2 trial for Stargardt’s macular dystrophy using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).
The patient was treated on Tuesday (Jan. 24) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA’s Jules Stein Eye Institute. The patient successfully underwent the outpatient transplantation surgery and is recovering uneventfully.
“This is the fourth patient worldwide treated with ACTC’s hESC-derived RPE cells,” said Gary Rabin, chairman and chief executive officer of ACTC. “We are pleased to be on schedule with our clinical programs to test the safety and tolerability of ACTC’s stem cell-derived RPE cells. We are working with the best ophthalmology institutes to evaluate the capacity of our cell therapy which may have the ability to treat a variety of devastating diseases.”
The clinical trial will enroll 12 patients each, with cohorts of three patients each in an ascending dosage format. It is a prospective, open-label study, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with Stargardt’s macular dystrophy at 12 months, the study’s primary endpoint.
The patient, a 47-year-old male, was treated with the smallest dose of 50,000 cells. The hESC-derived RPE cells are currently also in Phase 1/2 for dry age-related macular degeneration. Preliminary results for the first two patients in each of the Phase 1/2 clinical trials were recently reported in The Lancet.
A third Phase1/2 trial for Stargardt’s macular dystrophy was recently initiated at the Moorfields Eye Hospital in London, treating the first patient on Jan. 20.
Stargardt’s Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision loss, usually starting in children between 10 to 20 years of age.
Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium or RPE cell layer.
Further information about patient eligibility for the Stargardt’s macular dystrophy study is also available on www.clinicaltrials.gov
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