ACT Announces Aberdeen Royal Infirmary in Scotland as Additional Site for Phase 1/2 Clinical Trial Using hESC-Derived …
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc.
(“ACT”;
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 ACT.
“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 ACT. 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.
About Advanced
Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company
applying cellular technology in the field of regenerative
medicine. For more information, visit
http://www.advancedcell.com.
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ACT Announces Aberdeen Royal Infirmary in Scotland as Additional Site for Phase 1/2 Clinical Trial Using hESC-Derived ...