"This is well-studied, and we are taking a conservative, biologically plausible first step that is hopefully optimized for success." Schwartz said. These factors, natural immune privilege and pinpointing the anatomic location, theoretically improve the cells’ chances of implanting and functioning. Surgeons will inject 50,000-plus new RPE cells into the patient’s subretinal space, the space where native RPE cells are found and an "immunoprivileged" part of the eye where an immune system attack is less likely. Over time, the death of these cells and the eventual loss of photoreceptors, or light-sensitive cells, in the eye can lead to blindness as central vision is gradually destroyed. In both cases, the layer of RPE cells located beneath the retina deteriorates and atrophies. In contrast, Stargardt’s Macular Dystrophy can affect those at the other end of the age spectrum, usually starting in children between 10-20 years old. The number of people affected by this disease is expected to double over the next 20 years as the population ages. The dry form of macular degeneration is the most common form of the disease and the leading cause of blindness in the developed world, especially among people over the age of 55. Help can’t come too soon for those suffering from these eye diseases. The patients are the real heroes here." The study, which began last April, is slated to be completed by September 2013. "But these patients are all excited to do it because they want to open the door for this emerging field. "Patients understand that there may be little or no benefit to them directly in terms of this procedure," Schwartz said, adding that there are risks, known and unknown, associated with any new therapy. Schwartz made clear, however, that no one, including the patients, has any expectations of significant visual improvement, although preclinical studies showed that eyesight among test subjects did improve substantially. Researchers are hoping that one day stem cell therapy will transform the way doctors treat diseases - by replacing diseased cells with stem cells that have the singular ability to turn into heart cells, eye cells or any other that might be needed. It’s our hope that the procedure and the therapy turn out to be safe and that we can continue to move forward to learn more about this new therapy." "It’s major eye surgery in which we will be putting retinal pigment epithelial (RPE) cells derived from human embryonic stem cells into a special place in the eye, called the subretinal space. Steven Schwartz, JSEI’s retinal division chief and Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine and member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA. "There are substantial screening and health issues that have to be looked at before these patients undergo the surgery," said principal investigator Dr. Currently, early participants are being screened by a battery of tests to ensure they don’t have other conditions, including cancer. While these patients still have some vision, all are legally blind. Twelve patients with the dry form of age-related macular degeneration (dry AMD) will be enrolled for one trial, and 12 with Stargardt’s macular dystrophy will be signed up for the other. This FDA-approved study is only the second in the United States to use human embryonic-derived stem cells in patients and the first to address eye diseases. Researchers at the Jules Stein Eye Institute (JSEI) have begun two clinical trials to determine the safety of stem cell therapy and patients’ ability to tolerate it for the treatment of two common, currently untreatable degenerative eye diseases.
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