In an announcement today, Advanced Cell Technology said that Bascom Palmer Eye Institute had received IRB approval to become the third U.S. clinical site for testing ACT’s human embryonic stem cell-derived retinal pigment epithelial cells in the treatment of dry age-related macular degeneration. Bascom Palmer, one of the country’s premier eye institutes, joins UCLA’s Jules Stein Eye Institute and the Wills Eye Institute as the third U.S. site participating in the clinical trials.
The Bascom Palmer trial will be led by acclaimed retinal specialist Dr. Philip Rosenfeld, the father of the use of Avastin in the treatment of the wet form of AMD.
In addition, Moorfields Eye Hospital in London awaits its final approval to join in this important clinical trial for using stem cells in stopping the advancement of the dry form of AMD.
ACT Announces Approval of Bascom Palmer Eye Institute as Additional Site for Stem Cell Clinical Trial for dry Age-Related Macular Degeneration
Ranked as Number One Eye Hospital Eight Years in a Row by U.S. News & World Report, Bascom Palmer Will Participate as Site for ACT's Phase I/II Clinical Trial Using Human Embryonic Stem Cell-Derived RPE Cells for dry AMD
MARLBOROUGH, Mass. - Apr. 4, 2012 - Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that the Bascom Palmer Eye Institute in Miami, Fla., has received institutional review board (IRB) approval as a site for the company's Phase I/II clinical trial for dry age-related macular degeneration (dry AMD), using human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.
"We could not be more pleased that the Bascom Palmer Eye Institute has been approved as an additional site for our clinical trial for dry AMD," said Gary Rabin, ACT's chairman and CEO. "The prestigious Bascom Palmer Eye Institute is ranked as the number one ophthalmology hospital in the country by U.S. News & World Report eight years running, and has a particularly strong reputation in the area of macular degeneration. We are very much looking forward to working with Dr. Philip Rosenfeld, a renowned retina specialist and professor of ophthalmology at the University of Miami's Miller School of Medicine, and the rest of his team."
The Phase I/II trial is a prospective, open-label study designed to determine the safety and tolerability of the hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD. The trial will ultimately enroll 12 patients, with cohorts of three patients each in an ascending dosage format.
Further information about patient eligibility for the dry AMD study is available at www.clinicaltrials.gov; ClinicalTrials.gov Identifier: NCT01344993.
About dry AMD
Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. Age-related macular degeneration (AMD) is the leading cause of blindness in people over age 60 in the United States, and the vast majority of cases of AMD are of the "dry" form, which is currently untreatable.
About hESC-derived RPE Cells
The retinal pigment epithelium (RPE) is a highly specialized tissue located between the choroids and the neural retina. RPE cells support, protect and provide nutrition for the light-sensitive photoreceptors. Human embryonic stem cells differentiate into any cell type, including RPE cells, and have a similar expression of RPE-specific genes compared to human RPE cells and demonstrate the full transition from the hESC state.
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 www.advancedcell.com
About Bascom Palmer
Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine - part of UHealth - the University of Miami Health System, is ranked the best eye hospital in the nation, as published in U.S. News & World Report. Having earned an international reputation as one of the premier providers of eye care in the world, Bascom Palmer is also ranked #1 in patient care and residency training by Ophthalmology Times. As the largest ophthalmic care, research and educational facility in the southeastern United States, it treats more than 250,000 patients with nearly every ophthalmic condition each year and more than 12,000 surgeries are performed annually. To date, the Institute has trained more than 900 physicians, clinicians and researchers, many of whom now lead academic and clinical ophthalmology centers worldwide. With nearly 80 faculty members and 1,200 staff, the Institute demonstrates exceptional expertise in every ophthalmic subspecialty. Founded in 1962, Bascom Palmer has patient care facilities in Miami, Palm Beach Gardens, Naples, and Plantation, Florida. For additional information, contact the office of marketing and communications at (305) 326-6190, firstname.lastname@example.org , or visit www.bascompalmer.org