Retina India is a not-for-profit organization, registered with the Charity Commissioner, Mumbai, India, established for empowering people with retinal disorders, and bringing them and their families on a common platform with physicians, researchers, counselors, low vision and mobility experts and other specialists.
Sunday, July 31, 2011
Friday, July 15, 2011
Patients Undergo Embryonic Stem Cell Transplantation Treatment for Stargardt's Disease and Macular Degeneration
Advanced Cell Technology, Inc., a leading company in the field of regenerative medicine, has announced that two patients have been implanted with retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) in each of its two Phase 1/2 clinical trials for Stargardt's macular dystrophy and dry age-related macular degeneration (AMD).
The patients were treated on July 12, 2011, at the David Geffen School of Medicine at UCLA's Jules Stein Eye Institute in Los Angeles, USA. Both patients successfully underwent the outpatient transplantation surgeries and are said to be recovering uneventfully.
One patient in each clinical trial, the Stargardt's trial and the dry AMD trial, underwent surgical transplantation of a small dose (50,000 cells) of fully-differentiated RPE cells derived from human embryonic stem cells. The patients appear to have tolerated the surgical procedures well.
Regarding the clinical trial:
Both the Stargardt's trial and the dry AMD trial will enroll 12 patients each, with cohorts of three patients each in an ascending dosage format. Both trials are prospective, open-label studies designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with Stargardt's and dry AMD at 12 months, the studies' primary endpoint.
This is the first step in the clinical trial, which will potentially define the dose required to help treat the condition. If the trial succeeds, it opens doors to a potentially significant and new therapeutic approach to treating Stargardt's disease and AMD.
The primary objective of these Phase 1/2 studies is to assess the safety and tolerability of these stem cell-derived transplants. The patients will be carefully monitored over the course of the trials, to observe and report for any untoward and adverse event that may happen.
To know more of this trial, please click here.
About hESC-RPE Cells
RPE cells are highly specialized tissue located between the choroid and the 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 Stargardt's macular dystrophy:
Stargardt's macular dystrophy is one of the most common forms of macular degeneration in the world. Stargardt's causes progressive vision loss, usually starting 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.
About Age-related Macular Degeneration:
Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority of them suffering from the "dry" form of AMD - which is currently untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.
Dry AMD, the most common form of macular degeneration, Stargardt's and other forms of atrophy-related macular degeneration are untreatable at this time, and need effective therapies for treatment of these common forms of blindness.
Source
Tuesday, July 12, 2011
Market for Age-related Macular Degeneration and Diabetic Retinopathy Drugs Will Reach $5084m by 2014
A new report by visiongain, a London-based business information provider, predicts that the market for age-related macular degeneration (AMD) and diabetic retinopathy (DR) drugs will reach $5084m by 2014. This will make retinal diseases the most lucrative sector of the ophthalmic drugs market, overtaking the glaucoma sector.
The AMD and DR market generated $3173m in 2010, according to Macular Degeneration (AMD) and Diabetic Retinopathy (DR): World Drug Market 2011-2021, published in July 2011.
AMD and DR are retinal disorders that can lead to blindness. Between them, they have been the cause for over 13% of all blindness cases in the world, according to a most recent WHO assessment. Both AMD and DR will become more widespread in the coming decades, as the world's population ages and the global diabetes epidemic continues.
Genentech's development of Lucentis (ranibizumab) made the 'wet' form of AMD effectively treatable for the first time. The success of Lucentis spurred investment in R&D for retinal diseases. In 2011, new products for wet AMD, as well as treatments for the 'dry' form of AMD, and for DR and diabetic macular oedema, are all nearing approval.
August will see the approval of Eylea (aflibercept), Regeneron Pharmaceuticals' new AMD treatment. This will be the most important new product in the AMD and DR sector since the launch of Lucentis.
Visiongain's research suggests that scientific study of retinal diseases will yield more important insights in the next ten years. While Lucentis and Eylea target vascular endothelial growth factor (VEGF), products with new targets will gain importance as monotherapies and in combination with VEGF inhibitors.
Visiongain predicts that the AMD and DR market will grow steadily to 2021, with treatments for dry AMD and DR answering the serious unmet needs in the sector.
First VIDION® ANV® Therapy System Utilization in Switzerland for the Treatment of Neovascular Age-Related Macular Degeneration
NeoVista, Inc. has announced the first commercial utilization of Epimacular Brachytherapy in Switzerland. Epimacular Brachytherapy is performed using the VIDION (R) ANV Therapy system and is being offered as an adjunct therapy to anti-VEGF injections for the treatment of neovascular or wet age-related macular degeneration.
Professor Dr. Marc D. de Smet, Professor and Head of the Retina Unit at the Montchoisi Clinic in Lausanne feels Epimacular Brachytherapy with VIDION® is a surgical procedure that is technically feasible in good hands, with minimal to no risks and reduces the burden of follow up and retreatments.
As per the company, NeoVista’s phase 2 clinical study results continue to highlight the potential benefits of utilizing radiation with anti-VEGF therapy in treating wet AMD – especially on smaller classic lesions and patients with pigment epithelial detachments. They believe that their treatment approach, Epimacular Brachytherapy, greatly reduces the number of anti-VEGF injections, while maintaining visual acuity – especially in those lesion subtypes that typically require a large number of injections."
NeoVista’s Phase 3 study, CABERNET, is about to conclude the required 2 year patient follow-up. The initial data from this study is scheduled to be presented during the upcoming AAO Retina Sub-Specialty Meeting in Orlando, Florida, October 21. The NeoVista approach to treating wet AMD delivers a focused and fixed dose of strontium 90 beta radiation directly to the back of the eye, without damaging the adjacent healthy retinal vasculature. Importantly for patients, the systemic exposure to radiation is easily tolerated and the energy is delivered in a highly controlled manner to a local area. The effective dose from this one-time treatment is less than that from a typical chest x-ray to the entire body.
Some other articles on Epimacular Brachytherapy can be read here, here, here and here.
Tuesday, July 5, 2011
Sightseeing for blind people
New hope for diabetes treatment
Stem cells are now being used in medicine for a variety of disorders. These cells have become a source of great hope for a significant number of diseases in the regenerative medicine realm. They are also helping in the development of new drugs to prevent and treat such chronic and difficult to treat conditions such as Diabetes, Parkinson's disease, spinal cord injury and Macular Degeneration.
Dr. Ian Rogers, a Scientist at the Samuel Lunenfeld Research Institute of Mount Sinai Hospital in Toronto, Canada, has been working on creating stem-cell based treatments for diabetes. He and his colleagues use stem cells to create natural replacements for essential cells in the pancreas that are destroyed by the illness, specifically in Type 1 diabetes.
For the past five years, Dr. Rogers has been focused on developing the regenerative capacity of umbilical cord and adult stem cells for clinical use, and making them a part of the future standard of care. His latest project involves developing induced pluripotent stem cells which have the ability to develop into many different types of cells from umbilical cord blood cells. Increasing the regenerative capacity of cord blood cells would extend their healing capacity beyond the blood diseases for which they are used currently.
For treatment of diabetes, the researchers differentiate stem cells into the critical cells of the pancreas that, in healthy people, measure blood sugar and produce the amount of insulin required to process it. These specialized cells would then be implanted in people with diabetes to reactivate the natural process.
At this stage, Dr. Rogers' team is building a pancreas out of a surgical sponge, in effect a three-dimensional structure seeded with insulin-producing islet cells. Ideally, the pancreas would be grown in the lab and then placed under the skin of a person with Type 1 diabetes to restore their insulin production.
This is a highly sophisticated procedure. The most advanced research project in his lab is much simpler: regenerating blood vessels so people with Type 2 diabetes who have damaged fingers and toes, (resulting from peripheral vascular disease) can avoid amputation.
So far the pancreatic stem cell technique has been studied in mice with promising results, although trials in humans are several years away. Lab studies have demonstrated that mice with a damaged pancreas can regulate their blood glucose levels within normal ranges with the transplanted cells. Coaxing the stem cells to develop into functional islets is not efficient enough to start clinical trials, but Dr. Rogers' group is now working to fix this problem.
It is known that stem cell transplants carry the risk of rejection or even possible tumour formation. To make the procedure safe, Dr. Rogers' lab is working to place the cells into porous bags that will allow the exchange of molecules between the cells and the body, but prevent the cells from escaping. This will also allow a physician to top up or replace the cells if they stop working.
The cells have shown no adverse side effects, hopefully demonstrating safety for future benefit in people with diabetes. If the procedure works, a patient's cell implants would require replacements every few years in an outpatient procedure, to counteract the body's natural immune response that slowly destroys them. Thus, instead of insulin injections, a patient would be using stem cell injections to augment his glucose levels. At first, the cells are expected to reduce the number of injections a patient requires. Eventually, as the procedure of generating islets becomes more efficient, the patient will be able to go for months or even years without having to inject insulin.
As the researchers note, there is considerable excitement of the potential for stem cell research but, ultimately, its value will only be realized if it can be applied to real medical needs. Dr. Rogers, like many other scientists around the world, is focused on developing this technology to ultimately benefit patients.
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