Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Aberdeen Royal Infirmary, the largest of the Grampian University Hospitals in Scotland, has been confirmed as a site for its Phase 1/2 human clinical trial for Stargardt’s Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).
The Phase 1/2 trial is a prospective, open-label study designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with SMD.
“A leading medical institution in the United Kingdom, Aberdeen Royal Infirmary is an ideal partner for our European clinical trial for SMD,” said Gary Rabin, chairman and CEO of ACTC. “Moreover, we are particularly pleased that the lead investigator is Dr. Noemi Lois, a leading expert in SMD. We continue to forge ties with some of the best eye surgeons and hospitals in the world and work towards bringing this cutting-edge therapy closer to fruition. Our preliminary results to date keep us optimistic that we are on the right path both in terms of our science and the clinical team we are working with, particularly eye surgeons such as Dr. Lois.”
Stargardt’s Macular Dystrophy affects an estimated 80,000 to 100,000 patients in the U.S. and Europe, and causes progressive vision loss, usually starting in people between the ages of 10 to 20, although the disease onset can occur at any age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, the retinal pigment epithelium.
“The first Stargardt’s patient to be treated in the U.S. with stem cell-derived RPE cells was a patient who was already legally blind as a consequence of this disease” stated Dr. Robert Lanza M.D., the chief scientific officer at ACTC.
Preliminary results from the treatment of the first SMD patient were recently reported in The Lancet (23 January 2012) and have been characterized by experts in the field of regenerative medicine as providing early signs of safety and efficacy.
This approved SMD clinical trial that Dr. Lois and her team will participate in is a prospective, open-label study designed to determine the safety and tolerability of RPE cells derived from hESCs following sub-retinal transplantation to patients with advanced SMD, and is similar in design to the FDA-cleared US trial initiated in July 2011.
“It is an honor to have been designated as a site for this path-breaking clinical trial,” said Noemi Lois, M.D., Ph.D. “We could not be more pleased to be a part of this trial for a promising potential new treatment for SMD, using hESC-derived RPE cells.”
Dr. Lois is a is a member of the Department of Ophthalmology, NHS Grampian, and associated to the University of Aberdeen, Scotland, United Kingdom. Dr. Lois practices at the Aberdeen Royal Infirmary; she is an Ophthalmologist with special interest in Medical retina and Retinal surgery.
On January 23, 2012, the company announced that the first patient in this SMD clinical trial in Europe had been treated at Moorfields Eye Hospital in London.
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