Age-related macular degeneration is growing with the graying American population

By LESLIE BARKER GARCIA

DALLAS — Jennifer Tyler was driving down a country road in Oklahoma a couple of years ago when she noticed something odd. The telephone poles all had kinks in them.
"I thought, 'Wow, what's all that about?'" says Tyler, a Dallas fundraising consultant. "They all had distinctive bends in the middle."She pulled off the road and called a friend. "I knew something bad was happening," she says. "It was nothing I could ignore."Her friend referred Tyler to Texas Retina Associates. Tyler made an appointment and was diagnosed as having age-related macular degeneration.

AMD is a disease that causes significant vision loss in 1.75 million Americans. More than 10 million suffer from various forms of this potentially sight-stealing disease, more than glaucoma and cataracts combined, according to the American Macular Degeneration Foundation.By 2020, as the population ages, that number is expected to double.In addition, says Dr. Karl Csaky (pronounced like chalky) of the Retina Foundation of the Southwest, "more severe forms will be more of an issue."
"People who are in their 70s and 80s are extremely active," says Csaky, head of the foundation's Harrington Molecular Laboratory and an ophthalmologist with Texas Retina Associates. "If you had even a relatively small disturbance in vision, that could be extremely devastating in terms of what you're used to doing."Some vision disturbances, such as difficulty reading small print, are inherent with aging. The lenses of our eyes change and can no longer focus close up, so we rely on reading glasses.

Macular degeneration goes beyond the normal aging process. It affects the center of the retina; specifically, the 0.1 percent that's responsible for 99.9 percent of our fine vision, Csaky says."Unfortunately," Csaky says, "the central part is what gives you quality of life, the ability to read, drive, play golf, to discern faces."
He uses the analogy of a camera to explain the difference between normal eye aging and macular degeneration."The lens of the eye is like the lens of a camera," he says. "Cataracts are when the lens of the camera gets cloudy and the picture gets fuzzy. The solution? Change your lens, which is what cataract surgery is."In macular degeneration, your film has gotten old. We can change lenses, put in a special lens, and still have a bad picture because the film is starting to decay."

Macular degeneration has no cure, but those involved in studying and treating it point out glimmers of hope:Though it may cause legal blindness, rendering some victims unable to drive or read, it won't cause total blindness.Most kinds never progress past the initial stage. Diagnosis is not "a death sentence for vision," Csaky says.

Treatments can slow down and sometimes reverse the more severe cases of the condition. Diagnostic tools can catch it in its early stages.To check for it, "We dilate your eyes, use a lens and look for yellow spots (drusen) or pigmentation changes or bleeding," says Dr. Yuguang He, associate professor of ophthalmology at the University of Texas Southwestern Medical Center and a specialist in age-related macular degeneration. "It's not like it takes a blood test or X-ray to diagnose. We just look at it."

The sooner it's found, the better, he says. "There is a window in which we can do treatments."Most treatments are geared toward the more advanced form called wet macular degeneration. The early stage is called dry, which can progress to late-severe dry and sometimes lead to wet.Progression from the dry form to wet can be rapid. Tyler went to a doctor when she first had symptoms, so he was able to diagnose the disease early. Thus, she's been able to receive a relatively new and often successful treatment: a monthly shot directly into each of her eyes."It's psychologically and emotionally very draining," says Tyler, whose father has the dry variety of the disease.

The shot, explains Csaky, her doctor, inhibits a protein responsible for blood vessels growing and bleeding under the retina."We're not curing the disease," he says. "We're inhibiting, with a drug, a protein that's constantly being made, and with the injection it disappears for four to six weeks. The blood vessels are still there in a dormant state. If you don't treat them, they start to grow back."It's not comfortable, but patients tolerate it well, he says, though occasionally "we have a loved one faint who's watching. We use a topical anesthetic and a very, very small needle."

Although there is no surefire way to prevent the disease, studies have shown that eating fish two or more times per week helps reduce the risk, he says. "I take fish oil. I'm 54 years old and take it not only to prevent AMD but also to protect my heart, help my cholesterol. I tell patients, something good for your heart has to be good for your eyes."He also points out the Age-Related Eye Disease study of the National Eye Institution. Participants took large quantities of vitamins A and C, as well as zinc, copper and beta carotene. The regimen neither prevents the disease nor, in the study, did it have any effect on the dry form, but it "slowed the progression of the wet variety by 20 percent," he says.

Tyler, who declined to give her age, manages her ailment as best she can, getting injections and participating in a study. She is constantly aware of her surroundings, on the lookout for any line in a grid that appears curvy or wavy. She checks the spindles on her staircase, "whatever's around me," for possible distortion."It was never even in my mind, as driven and focused as I am in my career, that I wouldn't be responsive to it," she says. "It's your vision for heaven's sake. How scary is that?

"You can work with it and make it a positive thing, or it can devastate you. You make these choices in life. What am I going to do about it? Is it going to define me, or am I going to help define it?"Age-related macular degeneration (AMD) is the No. 1 cause of irreversible vision loss among senior citizens, according to the Retina Foundation of the Southwest. Some risk factors:

Caucasians are more likely to contract AMD than other races."If you're a Caucasian older than 65, there's a 20 percent chance you'll get it," says Dr. Yuguang He, associate professor of ophthalmology at UT Southwestern Medical Center. "If you're Chinese or Japanese, less than 5 percent. African-Americans have it much less than Caucasians."Yet, "as the Japanese adopted our diet, their incidence has gone up," says Dr. Karl Csaky of the Retina Foundation of the Southwest and Texas Retina Associates.

Smoking increases incidence."Cigarette smokers are 20 times more likely to develop AMD than nonsmokers," he says. "The chances are very, very high."

If one eye is affected, the other eye will be, too.It's important to periodically cover up the eye that has it to see whether the other eye is seeing distortions, too.Genetics play a factor."If your parents have it, there's an increased risk you'll get it, but it's not a guarantee," he says. "We're still struggling with the practical implications of these genetic associations other than scaring people."

Aarkstore Enterprise Macular Degeneration, Pipeline Review

by: Pipeline Review,Q4

Aarkstore announce a new report “Macular Degeneration – Pipeline Review, Q4 2010 ” through its vast collection of market research report.

“Macular Degeneration Pipeline Review, Q4 2010”, provides an overview of the Macular Degeneration therapeutic pipeline. This report provides information on the therapeutic development for Macular Degeneration, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Macular Degeneration. “Macular Degeneration-Pipeline Review 2010, Q4 2010” is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together.

Scope

- A snapshot of the global therapeutic scenario for Macular Degeneration.
- A review of the Macular Degeneration products under development by companies and universities/research institutes based on information derived from company and industry-specific sources.
- Coverage of products based on various stages of development ranging from discovery till registration stages.
- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.
- Coverage of the Macular Degeneration pipeline on the basis of therapeutic class, route of administration and molecule type.
- Profiles of late-stage pipeline products featuring sections on product description, mechanism of action and research & development progress.
- Key discontinued pipeline projects.
- Latest news and deals relating to the products.

- Identify and understand important and diverse types of therapeutics under development for Macular Degeneration.
- Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive advantage.
- Plan mergers and acquisitions effectively by identifying players with the most promising pipeline.
- Devise corrective measures for pipeline projects by understanding Macular Degeneration pipeline depth and focus of Macular Degeneration therapeutics.
- Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope.
- Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline., provides an overview of the Macular Degeneration therapeutic pipeline. This report provides information on the therapeutic development for Macular Degeneration, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Macular Degeneration. “Macular Degeneration-Pipeline Review 2010, Q4 2010” is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together.

FDA Approves Company's Clinical Trial Of hESCs- based Treatment for AMD

by: Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. (OTCBB: ACTC), a regenerative medicine company based in Marlborough, Mass., announced on January 3 that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to treat dry age-related macular degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

ACT is now permitted to launch a Phase 1-2 multicenter clinical trial to treat patients with dry AMD, the most common form of macular degeneration in the world.

There are no treatments available for this prevalent disease of an aging global population. According to the company, dry AMD, representing a substantial global market opportunity and afflicts between 10-15 million Americans.

Age-Related Macular Degeneration has two predominant forms, wet and dry. Dry AMD is the most common form, accounting for almost 90 percent of all cases. The progress of dry AMD includes a breakdown or thinning of the layer of RPE cells in the patient’s macula, the region at the center of the retina responsible for high acuity vision. Over time, the progressive loss of RPE cells and accompanying loss of photoreceptors can cause severe vision loss and even blindness.

“ACT is now the first company to receive FDA clearance for two hESC trials, and is now a true translational leader in the field of regenerative medicine,” said interim CEO Gary Rabin. “It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques. We plan to proceed into the clinic with both of our hESC-based programs as quickly as possible.”

The Phase 1-2 trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with dry AMD. Twelve patients will be enrolled in the study at multiple clinical sites. Sites currently under consideration are the Jules Stein Eye Institute at UCLA, and the Ophthalmology Department at Stanford University School of Medicine. Additional sites may be considered.

“Dry AMD is the leading cause of blindness in individuals over the age of 55,” said Robert Lanza, M.D., chief scientific officer. “As the population ages, the incidence of AMD is expected to double over the next 20 years, further exacerbating this unmet medical need. Using our clinical-grade hESC lines, we are able to generate a virtually unlimited and reproducible supply of healthy RPE cells. Because only a small number of cells (50-200K) are needed to treat each patient, manufacturing and distribution of the therapeutic product is scalable with many similarities to the drug businesses that pharmaceutical companies understand well. Based on our animal model studies, we are very excited about the opportunity to treat patients. In a rat model of macular degeneration, we have seen a remarkable improvement in visual performance over untreated animals, without any adverse effects. We have also maintained near-normal function in a mouse model of Stargardt’s Disease, a form of juvenile macular degeneration. In addition to this trial, we plan to concurrently use our RPE cells in our Phase I/II Clinical Trial for Stargardt’s Disease, which received the green light from the FDA in November. We hope to see a similar benefit in both Stargardt’s Disease and Dry AMD patients.”

ACT’s dry AMD therapeutic program uses RPE cells derived from hESCs to replace the lost RPE cells in the patient’s eyes. ACT’s proprietary RPE cell manufacturing process is protected by a number of broad patents, as is the use of hESC-derived RPE cells for treating macular degeneration. While the initial portion of the clinical trial will focus on safety, in subsequent clinical trials the company hopes to demonstrate that the RPE cells injected into the retinal space will be capable of slowing or halting progression of the disease, and potentially even restoring some visual acuity to patients.

“It is estimated that over ten million Europeans suffer from age-related macular degeneration, representing a vast unmet need and a significant market opportunity,” commented Edmund Mickunas, vice president of regulatory affairs. “We are moving ahead aggressively to seek regulatory clearance from the European Medicines Agency to conduct clinical trials in Europe.”

Case Western Reserve receives $10 million to study Retina Disease

by: Jessica Studeny

The Departments of Pharmacology and Ophthalmology and Visual Sciences at Case Western Reserve University School of Medicine have been awarded a $10.1 million grant from the National Eye Institute (NEI) to research and develop new treatments for diseases of the retina, a leading cause of blindness.

"The grant strongly positions the School of Medicine and collaborating organizations to play a significant role in advancing the treatment of retinal diseases in order to restore quality of life to countless patients," said Jonathan H. Lass, MD, professor and chair of the Department of Ophthalmology and Visual Sciences at Case Western Reserve School of Medicine and director of the University Hospitals Eye Institute. "It is the largest grant of its kind ever awarded to the university by the National Eye Institute, a tremendous achievement."

The NEI, part of the National Institutes of Health (NIH), will award the grant over five years, funding the work of researchers in the Departments of Pharmacology, Ophthalmology, and Biomedical Engineering at the School of Medicine who are working in collaboration with the Retinal Therapeutics Study Group. This interdisciplinary consortium of investigators is screening FDA-approved drugs for their potential application to the treatment of eye diseases affecting the retina.

The combined group, which also includes researchers from the Cincinnati Drug Discovery Center, the University of Pennsylvania and Washington University, aims to accelerate the rate at which basic science discoveries are used to develop new therapies for complex retinal disorders and diseases.

Conditions affecting the retina, the tissue in back of the eye responsible for vision, are a primary cause of blindness in adults in the United States. Such diseases include age-related macular degeneration (AMD), the main cause of blindness in adults over the age of 55. More than 1.3 million people in the U.S. are legally blind and 8 to 10 million aging individuals show signs of developing AMD, an incurable eye disease characterized by damage to the retina and the loss of central daylight vision.

"The research being funded by the NIH is critical to availing patients of new, more effective treatments, particularly for diseases like AMD, for which there is currently no cure," says Krzysztof Palczewski, PhD, John H. Hord Professor, chair of the Department of Pharmacology, and principal investigator and director of the research funded by the new NEI grant. "Our goal is to develop new drugs based on the screening of FDA-approved drugs to evaluate their effectiveness in treating retinal diseases."

Researchers will employ a range of scientific expertise and state-of-the-art physiological, chemical and analytical imaging technologies to test potential retinal disease therapies in basic research models. A non-invasive imaging technology developed at Case Western Reserve by Dr. Palczewski's research group will facilitate monitoring of the retina to detect molecular changes, defects, or harmful toxins in the retina.

FDA-approved drugs will be screened for their potential application in research models engineered to mimic conditions such as AMD, Stargardt's disease (a form of inherited juvenile macular degeneration) and retinitis pigmentosa (a group of inherited retinal disorders characterized by progressive peripheral vision loss). The drug-screening process is designed to accelerate the process of drug development before clinical testing in humans.

Dr. Palczewski is working with researcher Akiko Maeda, MD, PhD, senior instructor in the Departments of Ophthalmology and Pharmacology; and Zheng-Rong Lu, PhD, professor of biomedical engineering; to hone in on existing drugs with chemical properties and initial research results that suggest they may provide a basis for developing new drugs for treating retinal diseases like AMD.

The research builds upon previous work in Dr. Palczewski's laboratory which identified mechanisms in the eye responsible for metabolizing vitamin A, an essential step in triggering the nerve signals sent to the brain to enable vision. Researchers determined that in healthy patients, this visual cycle operates rapidly. However, in older patients and those with AMD and Stargardt-like diseases, one of the critical biochemical reactions in the series that recycle vitamin A is slowed. This allows a toxic byproduct produced by the breakdown of vitamin A to accumulate, which damages the retina over time, probably contributing to the development of AMD and/or impairing vision.

The combined teams in Ophthalmology and Pharmacology are now looking for drugs that can target the mechanism that captures toxic vitamin A metabolites, to neutralize and counter the build-up of any visual cycle toxic byproduct, as a means of preventing or controlling retinal diseases. "Current treatments for AMD focus on management of the late stages of the disease. These studies could result in treatments at the earlier stages and save more vision as a result" says Dr. Lass.

In addition to testing existing FDA-approved drugs for their ability to reduce toxic substances within the retina, priorities for the NIH-funded research also include evaluating existing FDA-approved drugs as potential lead compounds for retinal diseases because these drugs have already been proven safe and effective in basic research and clinical studies for other indications. Researchers will likewise assess the ability of potential compounds to penetrate and remain in the eye without negatively affecting vision and they will explore and develop new drug delivery systems to achieve and maintain therapeutic drug concentrations in the eye.

"We have an idea as to what drugs could be most effective for our purposes," said Dr. Maeda, who relocated from Japan to the United States to work with Dr. Palczewski. She is the study's co-principal investigator and a group leader who is responsible for basic research models. "During my clinical practice in ophthalmology, I was very frustrated with the lack of treatment options for many patients with retinal degenerative diseases, and I became determined to dedicate myself to developing new treatments for these patients through basic science research. I am very excited to develop our ideas for treating currently incurable retinal diseases."

Dr. Palczewski and his team have already examined 24 FDA-approved drugs, from antibiotics to drugs fighting cancer and infectious diseases, for their ability to attack the buildup of harmful toxins in the retina. These studies were done with mice that were genetically engineered to mimic Stargardt's disease. At least 16 of the drugs tested have already demonstrated the potential to limit the progression of retinal diseases. The resulting data provided the basis for funding the $10 million NIH grant request.

About Case Western Reserve University School of Medicine

Founded in 1843, Case Western Reserve University School of Medicine is the largest medical research institution in Ohio and is among the nation's top medical schools for research funding from the National Institutes of Health. The School of Medicine is recognized throughout the international medical community for outstanding achievements in teaching. The School's innovative and pioneering Western Reserve2 curriculum interweaves four themes--research and scholarship, clinical mastery, leadership, and civic professionalism--to prepare students for the practice of evidence-based medicine in the rapidly changing health care environment of the 21st century. Nine Nobel Laureates have been affiliated with the school of medicine.

Annually, the School of Medicine trains more than 800 MD and MD/PhD students and ranks in the top 20 among U.S. research-oriented medical schools as designated by U.S. News & World Report "Guide to Graduate Education."

The School of Medicine's primary affiliate is University Hospitals Case Medical Center and is additionally affiliated with MetroHealth Medical Center, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and the Cleveland Clinic, with which it established the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in 2002.

Age-Related Macular Degeneration Research from University of Bristol

by: University
"Neovascular age-related macular degeneration (nvAMD) is a chronic, progressive disease of the central retina, and its prevalence is expected to rise with the aging population. Using a bottom-up approach based on retrospective data, this cross-sectional study estimated average annual direct costs of nvAMD to be A 4,047 pound, and average annual indirect costs to be A 449 pound," scientists in Bristol, the United Kingdom report.

"An attempt to measure intangible costs through willingness-to-pay yielded a lower response rate and estimated intangible costs to be 11.5% of monthly income. Direct costs were significantly higher for male participants, for those who have mild or moderate visual impairment in both eyes, and for those who have been diagnosed for a shorter time," wrote K.M. Ke and colleagues, University of Bristol.

The researchers concluded: "The findings of this study suggest that the availability of early diagnosis, effective treatment, support services, and sustained research into the management of nvAMD may reduce the burden of visual impairment caused by nvAMD to affected individuals and the state."

Ke and colleagues published their study in European Journal of Health Economics (The direct, indirect and intangible costs of visual impairment caused by neovascular age-related macular degeneration. European Journal of Health Economics, 2010;11(6):525-531).

For additional information, contact K.M. Ke, University of Bristol, Bristol Dental School, Dept. of Oral & Dental Science, Lower Maudlin St., Bristol BS1 2LY, Avon, UK.

The publisher's contact information for the European Journal of Health Economics is: Springer, 233 Spring St., New York, NY 10013, USA.

Keywords: City:Bristol, Country:United Kingdom, Age-Related Macular Degeneration, Retinal Degeneration, Retinal Diseases

The link Between Age-Related Macular Degeneration and Cardiovascular Disease

by:Johns Hopkins Health Alert

Several studies have found that people with age-related macular degeneration (AMD) are more likely to have heart disease than those without age-related macular degeneration. A U.S. Medicare study, for example, found that elderly people with age-related macular degeneration were 20% more likely to have a heart attack than their counterparts who didn't have age-related macular degeneration. And a large Australian study, reported in the British Journal of Ophthalmology, suggests that age-related macular degeneration increases the risk of dying from coronary heart disease or stroke.

The researchers used data from nearly 3,000 participants, age 49 and older, in the Blue Mountains Eye Study -- none with a history of coronary heart disease or stroke at enrollment. They found that people younger than age 75 who had early signs of age-related macular degeneration at the study's start were twice as likely to die of coronary heart disease as their counterparts who did not have early signs. However, there was no increased risk of dying of a stroke in this group.

People with late age-related macular degeneration at the beginning of the study who were under age 75 had five times the risk of dying of coronary heart disease and 10 times the risk of dying of a stroke. The link between late age-related macular degeneration and risk of death from cardiovascular disease should be interpreted cautiously, warn the researchers, because there were so few people with late age-related macular degeneration at study entry.

Surprisingly, the researchers found no increased risk of death from cardiovascular disease among people over age 75 with age-related macular degeneration. They speculate that past 75, patients died of other serious health conditions that overshadowed the connection.

Take-away message: What's behind the link between age-related macular degeneration and cardiovascular disease? Some researchers suspect that age-related macular degeneration and cardiovascular diseases may share a common genesis: for instance, atherosclerosis, inflammation, and oxidative stress (the cell damage caused by free radicals) are known to affect both conditions. Another alternative: age-related macular degeneration may simply be a disease of aging.


Medical Disclaimer: This information is not intended to be substituted for the advice of a physician. Johns Hopkins Health Alerts

SiemCells, Inc. Expands SC Proven(R) Product Portfolio With launch of Proprietary Human Cell Detection Antibodies

Posted by: StemCells,Inc.


StemCells, Inc. (Nasdaq: STEM | PowerRating) announced today the launch of STEM101(TM), STEM121(TM) and STEM123(TM), three new antibody reagents that significantly improve the visualization of human cells, including human stem cells and their progeny. These high potency antibodies are the latest additions to the Company's growing SC Proven(R) portfolio of research products, and provide powerful, cost-effective tools for the detection, tracking and characterization of human cells both in vitro and when transplanted into animal models of human diseases.

"The commercial launch of these proprietary antibodies demonstrates our ongoing commitment to broaden our portfolio of innovative research products and to take advantage of the growing market for research-grade cells, media and reagents," said Stewart Craig, Senior Vice President, Development and Operations at StemCells, Inc. "Their utility has been proven by our scientists and by independent academic collaborators in the conduct of their research and development activities. These antibodies have also become the cornerstone of our extensive preclinical studies, which have allowed us to successfully advance our stem cell therapeutic candidates into multiple clinical trials. There is considerable demand for these reagents, so we are pleased to now make them available to the scientific community at large."

STEM101, STEM121 and STEM123 are human-specific mouse monoclonal antibodies that have been extensively used to detect the engraftment, migration and differentiation of human neural stem cells and human liver engrafting cells (hLEC(TM)) transplanted into rodents.1,2,3,4,5 These antibodies can be used for immunohistochemistry and immunofluorescence applications such as:

-- Quantifying the location and number of engrafted cells

-- Tracking the migration pattern of engrafted cells

-- Determining the nature of engrafted cells

-- Identifying specific differentiated human-derived cells such as

astrocytes
STEM101 recognizes the Ku80 protein found in human nuclei, STEM121 recognizes a cytoplasmic protein of human cells, and STEM123 recognizes human glial fibrillary acidic protein (GFAP).

About SC Proven Products

The SC Proven product portfolio comprises a range of specialty cell culture products that enable the standardized and reproducible production and propagation of highly purified stem cells and their differentiated progeny, as well as reagents for cell detection, isolation and characterization.

References

-- Kelly S, et al. Transplanted human fetal neural stem cells survive,

migrate, and differentiate in ischemic rat cerebral cortex. PNAS (2004)

101:11839-11844

-- Cummings B.J., et al. Human neural stem cells differentiate and promote

locomotor recovery in spinal cord-injured mice. PNAS (2005) 102:

14069-14074

-- Tamaki S.J., et al., Neuroprotection of Host Cells by Human Central

Nervous System Stem Cells in a Mouse Model of Infantile Neuronal Ceroid

Lipofuscinosis. Cell Stem Cell (2009) 5:310-319

-- Kallur T., et al. Human Fetal Cortical and Striatal Neural Stem Cells

Generate Region-Specific Neurons In Vitro and Differentiate Extensively

to Neurons After Intrastriatal Transplantation in Neonatal Rats. J

Neurosci Res. (2006) 84:1630-1644

-- Salazar D.L., et al., Human Neural Stem Cells Differentiate and Promote

Locomotor Recovery in an Early Chronic Spinal Cord Injury NOD-scid Mouse

Model. PLoS ONE (2010) 5: e12272

About StemCells, Inc.

StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. In its therapeutic product development programs, StemCells is targeting disorders of the central nervous system and the liver. StemCells' lead product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in clinical development for the treatment of two fatal neurodegenerative disorders in children, and in preclinical development for spinal cord injury and retinal disorders such as age-related macular degeneration. StemCells also markets research products, including media and reagents, under the SC Proven(R)brand, and is developing stem cell-based assay platforms for use in pharmaceutical research, drug discovery and drug development. Further information about StemCells is available at www.stemcellsinc.com.

The StemCells, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7014

Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the ability of STEM101, STEM121 and STEM123 to enable and improve the visualization, detection, tracking and characterization of human cells both in vitro and when transplanted into animal models of human diseases; the clinical development of the Company's HuCNS-SC cells; the prospects for the Company to pursue non-therapeutic applications of its cell-based technologies; and the future business operations of the Company. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including those described under the heading "Risk Factors" in the Company's Annual Report
on Form 10-K for the year ended December 31, 2009, and in its subsequent reports on Form 10-Q and Form 8-K.

UC Santa Barbara Part of International Research Collaboration Focusing on Age-Related Macular degeneration Cure

By AScribe Newswire

SANTA BARBARA, Calif., Nov. 15 - An international collaboration between UC Santa Barbara, the Keck School of Medicine of the University of Southern California (USC), and several other research institutions, is bringing together leaders in the fields of stem cell biology, basic science, and ophthalmology to develop a treatment for blindness caused by age-related macular degeneration.

The California Project to Cure Blindness (CPCB) was formed with a $16 million California Institute for Regenerative Medicine (CIRM) "disease team" grant awarded in late 2009 to fund development of a stem cell-based treatment for age-related macular degeneration. As part of the CIRM Disease Team partnership program, an additional $4.1 million from Britain's Medical Research Council funds collaborative work at University College of London.

"UCSB scientists in the Center for Stem Cell Biology and Engineering and the Center for the Study of Macular Degeneration are excited to provide the basic research that will allow translation of stem cell research to the clinic," said Dennis Clegg, professor in UCSB's Department of Molecular, Cellular, and Developmental Biology, and co-director of the UCSB Center for Stem Cell Biology and Engineering. Both centers are part of UCSB's Neuroscience Research Institute. Grant funds totaling $2.5 million for this work were assigned to UCSB through USC.

The overall grant was awarded to principal investigator Mark Humayun, professor of ophthalmology, cell and neurobiology and biomedical engineering at the Keck School, and David R. Hinton, professor of pathology and ophthalmology at the Keck School. Co-investigator is Martin Pera, director of the Eli and Edythe Broad CIRM Center for Regenerative Medicine and Stem Cell Research at USC.

"With this collaboration, we hope to accelerate research on a stem cell-based therapy for age-related macular degeneration," said Humayun. "Age-related macular degeneration is the leading cause of irreversible vision loss, affecting one in three people age 75 or older. The CIRM grant enables us to work with numerous researchers and experts who are dedicated to finding the cure to this devastating medical condition."

The cause of blindness in age-related macular degeneration is the death of retinal pigment epithelial cells, which provide critical support of photoreceptor function and health. The project objective is to replace damaged retinal epithelium with healthy tissue derived from human embryonic stem cells to prevent loss of vision.

Stem cell therapy offers the possibility of a wider range of options for age-related macular degeneration patients, said Keck School Dean Carmen A. Puliafito. "While exciting new pharmaceuticals to treat age-related macular degeneration are now available, these are effective only in a select group of patients, and can be used only during a narrow time window," said Puliafito, an ophthalmologist whose academic focus is macular degeneration. "In contrast, stem cell therapy promises to be broadly applicable. The potential is tremendous."

CIRM President Alan Trounson noted that the disease team approach exemplified by the California Project to Cure Blindness could transform the direction of future research.

"Scientists have talked for years about the need to find ways to speed the pace of discovery," said Trounson. "CIRM, through the Disease Team Award Program, has encouraged applicants to form teams composed of the best researchers from around the world. The partnership between the California Project to Cure Blindness and Britain's Medical Research Council is a great example of CIRM's vision of a new standard for funding translational research."

OGI invests in personalized medicine for age-related macular degeneration

by administrator

Established in 2007 and based in Toronto, ArcticDx has developed a test, Macula Risk®, the first of its kind and specifically designed to determine one's inherited risk for age-related macular degeneration (AMD), the most common form of acquired blindness in the developed world, affecting over 10% of individuals. ArcticDx will use the PBDF investment to undertake studies in support of a planned filing for Food and Drug Administration (FDA) approval for Macula Risk.

Macula Risk detects variations in genetic markers known to predict the progression of early asymptomatic AMD to blindness using a cheek swab sample. The eyesight of individuals who are genetically predisposed to blindness can be saved through enhanced surveillance and early treatment. Macula Risk helps target effective care to those who need it most and relieves others who would otherwise live with uncertainty.

"The investment from OGI will support our filing for FDA approval for Macula Risk," commented Mr. Gregory Hines, CEO of ArcticDx. "We think this approval is an important departure from the growing trend of direct to consumer marketing of genetic tests that have only a weak link to science and are often of no clinical value. Macula Risk stands as the best example of a validated test for a multi-genetic common human disease. Achieving FDA approval will position Macula Risk for wide spread adoption."

The Macula Risk test will be marketed to eye care professionals who manage most cases of AMD in North America. These doctors will offer the test to individuals with the dry form of the disease who have not yet lost vision.

In the industrialized world, AMD is the major cause of uncorrectable vision loss in the elderly, affecting over 2.5 million people in Canada and over 25 million people in the USA. Age?related macular degeneration is generally a disease of the elderly with the worldwide incidence of the disease growing from one in ten people over the age of 60 to more than 1 in 4 people over the age of 75. Macular degeneration is more common than Parkinson's disease, Alzheimer's disease, breast cancer and prostate cancer combined.

"Application of genomics technologies is opening the door to an era of personalized medicine in our approach to preventing, detecting and treating human disease," commented Dr. Christian Burks, President and CEO, OGI. "We are particularly pleased to be investing in a company that grew out of applied research funded by Genome Canada through OGI."

The funded work will focus on a cohort of patient samples who had early stage AMD in the Age-Related Eye Disease Study (AREDS), a large eye survey carried out by the American National Eye Institute. These patients were followed over a five-year period to determine progression of the disease. The ArcticDx team will undertake a prospective study on this cohort to evaluate use of Macula Risk in predicting which patients will progress to wet AMD (the late form of AMD) and which will not.

OGI's PBDF program invests in opportunities ? based in genomics, proteomics or associated technologies ? that fall in the proof-of-principle (validation) phase of research and that have the short-term potential to secure a significant next step towards the marketplace. Previous recipients have included Ontario universities, research institutes and companies.

CIRM to dole Out $72M to Advance Research and Recruit Stem Cell Scientist

The California Institute for Regenerative Medicine (CIRM) approved funding for 19 awards worth $67 million under the Early Translation II Awards program. The 29-member governing board also voted to approve the second Research Leadership Award of $4.8 million, given to aid in recruiting Peter Coffey, D.Phil., from the University College London to the University of California, Santa Barbara.

The Early Translation II Awards are the second of what CIRM expects to be a 12- to 18-month award cycle for translational research grants. The funded projects are expected to either result in a candidate drug or cell therapy or make significant strides toward such a candidate.

“We are looking for ways to complement our leading edge of stem cell-based treatments for patients, and these projects will load our frontline portfolio with promising studies on autism, muscular dystrophy, Canavan disease, and liver disease,” says Alan Trounson, CIRM president.

The awards went to one for-profit and 11 not-for-profit institutions. The for-profit company iPierian will take its award in the form of a loan. Three of the awards include collaborators in Germany. The portion of the projects carried out by these collaborators will be supported by the Federal Ministry of Education and Research, the science financing agency in Germany, which will fund up to $15 million for this round of awards.

The $4.8 million grant under the Research Leadership Award program will be spread over six years and will back Dr. Coffey’s research on maturing embryonic stem cells into retinal pigment epithelial cells to treat macular degeneration and other forms of vision loss such as diabetic retinopathy and retinitis pigmentosa. Dr. Coffey is part of a team working toward a therapy for macular degeneration led by Mark Humayun, M.D., Ph.D., at the University of Southern California.

“Recruiting internationally renowned stem cell experts such as Dr. Coffey builds a critical mass of stem cell leadership in California to drive the creation of innovative therapies for patients suffering from chronic disease or injury,” notes Robert Klein, chair of the CIRM governing board.

Vitamin A pill could save sight

By Fiona Macrae
A drug based on vitamin A could prevent millions from going blind as they get older, doctors believe.

The treatment was able to stop the most common cause of blindness in old age during trials.

Researchers behind the drug, fenretinide, found it halted the advance of age-related macular degeneration, for which there is currently no cure.

They targeted the most prevalent form of the condition, known as ‘dry’ AMD, which is caused by the deterioration and death of cells in the macula – the part of the retina used to see straight ahead.

The disease robs sufferers of their sight by creating a blackspot in the centre of their vision.

It can make it impossible to carry out everyday tasks such as reading, driving and watching television.

While the less common ‘wet’ form can be treated, nothing can be done to help the bulk of patients.

The U.S. research studied fenretinide, which is derived from vitamin A, the vitamin found in carrots, and which was originally designed to tackle arthritis.

Almost 250 men and women with dry AMD took a fenretinide pill a day or a placebo.

In the highest dose, the drug halted visual deterioration after a year. This suggests that while it was unable to do anything to stop cells that were already damaged from dying, it protected healthy cells. Although the research is still preliminary, it offers promise of a treatment for the disease.

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It affects millions across the world and 300,000 Britons. The number of UK sufferers could more than treble to one million within 25 years as the population ages.

Dr Jason Slakter, of New York University School of Medicine, said: ‘There are currently no effective treatments for dry AMD and the need for finding one is grave.

‘Our study wasn’t designed to give a final answer.

‘It was designed to see if there was a biological effect and if the drug was working in the way we’d expect and to find out if it was well tolerated by patents.

‘I think we answered all of these points favourably. The bottom line is that I am excited about doing more studies.’

Further, larger trials are planned for the end of next year.

If the drug lives up to its initial promise, it could be in widespread use for dry AMD by 2015.

The treatment works because in normal circumstances the eye needs vitamin A to help it see. The retina naturally uses the vitamin and is helped to do so by a compound called retinol binding protein, or RBP.

However in some patients, the vitamin can produce poisons that kill the delicate cells, leading to loss of vision.

Fenretinide acts as a decoy, attaching itself to the RBP and stopping vitamin A from causing harm, the American Academy of Ophthalmology’s annual conference heard.

Wet AMD, in which tiny blood vessels bleed into the retina, is less common, but progresses more rapidly, with central vision being lost within months of diagnosis.

Caught early enough, wet AMD can be stopped in its tracks by a technique called photodynamic therapy, which uses a light-activated dye to destroy abnormal blood vessels. Drug treatments are also available.

Fenretinide also halved the odds of the patients, who already had dry AMD, going on to develop wet AMD.

A spokesman for the research team said: ‘Years of use of fenretinide to treat cancers, rheumatoid arthritis have shown it to be safe and well-tolerated.’

Portable Macular Degeneration (AMD) Early Detection & Screening Device

Health Research Sciences has developed a new portable device allowing early detection of the leading cause of blindness in the US; Age-Related Macular Degeneration (AMD) and Diabetic Maculopathy. This inexpensive and portable device will be an integral part during the next few years in the fight to reduce AMD in the US.

Lighthouse Point, Florida September 30, 2010. Health Research Sciences introduces a new approach for testing macular function with the purpose of early detection of Age-Related Macular Degeneration (AMD), Diabetic Maculopathy and other retinal pathologies. The MDD-2 Macular Degeneration Detection & Screening Device has a unique, hand-held design that measures photostress recovery and solves the problem of inconsistent macular function testing.

The MDD-2 provides reproducible measurements of macular function (precise photostress recovery times) which are documented in a concise format for health professional interpretation. The MDD-2 also permits monitoring of central retinal health over time and can warn of deterioration in function at an early stage. Over 10 million Americans suffer from vision loss due to Macular Degeneration and approximately 4 million Americans are at risk for vision loss from Diabetes and further that these vision disorders cost all Americans over $1 billion annually.

The MDD-2 enables Ophthalmologists, Optometrists, Primary Care Physicians and Endocrinologists to easily and efficiently measure macular function for the purpose of early detection of AMD, Diabetic Retinopathy and other central retinal diseases. The test may be administered by a trained technician/assistant and takes approximately 4 minutes to complete. Results are available immediately and easily interpreted by the physician.

“As Professor of Ophthalmology and Pathology, Johns Hopkins University, School of Medicine, I am very concerned about the need for early detection of Age Related Macular Degeneration (AMD) and Diabetic Retinopathy in the United States. I believe that dark adaptation and photostress recovery measurement are both effective tests for evaluating the function of the macula, detecting macular degeneration and diabetic retinopathy at an early stage.”

Mark O.M. Tso, M.D., D. Sc.

Shark Liver Oil and Cartilage could provide Rescue

By Debbie Nicholson

Sharks are labeled with a bad persona. Mainly due to movies like "Jaws" where they go around and chomp down for a nightly feast on any human or animal they can find. There are one million slaughters going on each year on this creature. However, these creatures of the sea have the ability to aide in certain medical conditions such as anemia, brain bleeding and cancer.

Scientists for decades have been studying the shark, well at least his cartilage. They believe this creature has something that can offer the medical community especially in the treatment of cancer. It is a known fact that sharks hardly ever get cancer. There must be something in their bodies that aide in protection from this disease.


The theory of the shark cartilage and cancer among most of the scientific community is having to do specifically with the composition of the cartilage. For one thing cartilage cannot grow cancer due to the fact it has no blood vessels. The theory is that the cartilage manufactures elements that barricade the growing of new blood vessels that would feed on the tumor. So by using the cartilage to treat the tumor the blood vessels then should be stopped from developing on the tumor.

A study was performed to scientifically prove or disprove the theory of shark cartilage. Nine patients had participated in this study. When the study had been completed the evidence indicated that seven of the nine patients who had advanced cancer there was an 87% positive response from the treatment. It is important to note that no other treatment was applied during this study.

The evidence laid out had shown the following results (in brief form here after seven weeks of treatment and all patients were diagnosed as terminal)

A few results:

Female patient stage three uterine cancer going into bladder. Radiation had no effects on the tumor. After seven weeks of the cartilage the tumor reduced in size by 80% and after eleven weeks the tumor had gone and so did her pain. The only remaining factor was scar tissue.

Female with vaginal hemangioma in size of 5"x 5" after hysterectomy and partial vaginectomy along with radiation. Heavy bleeding was life threatening complication. At seven weeks tumor reduced by 60% and bleeding had stopped. At eleven weeks tumor size was 3"x 3" with further treatment it was stated tumor would appear to decrease.

Male stage three cancer on back of right thigh. After nine weeks of cartilage therapy surgery was done. It was noticed that 60% of the tumor was dead and surgically removed.

The summary of this research had indicated that further research was still required but shark cartilage treatments had displayed promise.

Studies on shark cartilage are still being conducted however, these studies are extremely expensive. At the same time environmentalists are advocating for the shark and making the fact known that the shark population has decreased significantly in the prior fifteen years due to over fishing and the ever on going demand for shark products.

The compounds of the shark cartilage are being tested by a few pharmaceutical companies. If developed it would only be able to be available by prescription and it is stated the cartilage is coming from those sharks who have been slaughtered for meat.

Shark cartilage in research has shown it can help alleviate arthritis symptoms. In all reality scientists had determined it is one of the main components in the shark cartilage which is chondroitin sulfate that is the magic behind the alleviation. To make a note the supplements which are sold in health food stores usually come from cows and that of sharks.

Shark cartilage has demonstrated benefits in patients with arthritis. It decrease joint pain and inflammation which enabled patients to use less pain relievers. Good news is a lot of persons who use it in small doses have no major problems. Some can have side effects which include nausea, vomiting, cramping, can lower blood pressure and raise sugar levels. Pregnant women, children and those recovering from surgery are advised against using the product. It has been validated for use in osteoporosis.

Shark cartilage has also been noted to be used for psoriasis, healing wounds, retina damage due to diabetes and inflammation of the intestines. The FDA has given the cartilage "Orphan Drug Status"for renal cell carcinoma. This law allows drug pharmaceuticals special incentives to study drugs for rare conditions.

Currently there has been no reported cases for drug interactions of this product. Doses are dependent on a variety of factors such as age, health and other conditions. There is no current information for proper dosage of this product. Follow directions on label and consult health practitioner before using this product.

Shark liver oil is also being used to treat health conditions. The liver oil is either brown or yellow in appearance. Fisherman for a very long time have used the oil for health treatments. The oil is an abundant source alkyiglycerols which just possibly contain anti-cancer elements. There are currently two other chemicals in the oil which are being studied for cancer they are squalene and squalamine.

Shark liver oil is vastly used in northern Europe as one of the conventional cancer treatments. However, in the United States it is sold as a dietary supplement. Current research is aiming at the components of the oil alkyiglycerols, squalene and squalamone. Past scientific studies have demonstrated the oil possibly has anti-cancer reactions on tumors in animals. Clinical trails based on if it works in humans are currently being studied.

We do know that shark liver oil aides in heightening the immune system, fighting infections, in cancer treatments (northern Europe) and decreases side effects of conventional cancer treatments.

The theory of the alkyiglycerols provide benefits in several different ways. It has been proposed that when fighting cancer they kill off the tumor cells indirectly. Advocates allege they stimulate the immune system by activation of immune cells (macrophages) that eat germs that are trying to penetrate along with damaged cells. The other way is that they have the ability to lessen side effects from chemotherapy and radiation therapy. This is due to the fact they can guard the cell membrane.

Due to the ability to heighten the immune system, there are claims that they provide protection against colds, flu, chronic infections, asthma, arthritis and AIDS.

Previous studies have demonstrated that squalamine can slow down the growing of tumor blood vessels. Advocates lay claim that it just possibly could treat cancer either independently or with chemotherapy. It is currently in studies for macular degeneration, eye condition in which ends in vision loss. Squalene is advocated to having cell protection ability which in turn could possibly lessen side effects that occur from chemotherapy.

All claims to shark liver oil are currently being researched.

Based on how the oil is prepared for commercial use it possibly can be loaded with omega 3 fatty acids and Vitamin A. The oil has been used in already in some moisturizing skin creams and lotions. Just to note some cosmetic companies have removed the ingredient over concern for the decline in the shark population.

The shark liver oil is being sold in capsules and liquid forms. You can purchase it at many of the health food stores and over the internet.

To clarify a few points in the shark liver oil. There is no current evidence that the supplement are effective to treat cancer. There have been a couple of studies that did present some benefit to women who were having radiation therapy for cervical cancer. There has been no other confirmed research in this area since 1980.

Recent studies have demonstrated squalamine has lessened the amounts of lung metastases, tumors in which spread to lungs from a primary cancer which is elsewhere in the body and this was found in animals. Studies conducted early in humans did show it can be used safely with chemotherapy. It is still not determined if it does shrink the tumor or prolongs survival of patients. It is undergoing studies with other treatments for lung and prostate cancers.

Some side effects include nausea and upset stomachs have been noted. In animal studies it had shown it could raise blood pressure. If you are allergic to seafood you could have a reaction.

The dosage for shark liver oil is also undetermined at this time so it is advisable to talk with your practitioner first.

Please do not use this product on its own current merit solely. It is used to aide in other treatments and best used with the advice of your health care practitioner.

AstraZeneca joins UCL to find stem cell cure for diabetic blindness

* Julia Kollewe
12 September 2010

AstraZeneca and University College London (UCL) will announce a research partnership tomorrow to develop medicines that use stem cells to repair damaged eyesight in people with diabetes.

Under the three-year deal funded by the drugmaker, researchers from AstraZeneca will team up with scientists at the UCL Institute of Ophthalmology to work on new medicines that use the regenerative capacity of stem cells. They hope to come up with a compound in three to five years, which could then undergo clinical development and possibly be on the market in 10 years' time.

Dr Marcus Fruttiger of the UCL Institute of Ophthalmology, who is leading the project, said: "These tools could be used either to manufacture transplantable material or to directly stimulate new cell growth in the eye to help restore or improve the vision of those with diabetic retinopathy [DR]."

DR is now the most common cause of vision impairment or blindness among western people of working age. The majority of patients with type-1 diabetes, which occurs when the body produces no insulin and often develops during the teenage years, will suffer eyesight problems and about 20%-30% will become blind. Moreover, at least 50% of patients with type-2 diabetes – the far more common type of diabetes, which occurs when the body produces too little insulin or when cells in the body do not react properly to insulin – will also develop retinopathy over time.

With the rapid spread of type-2 diabetes, which is linked to obesity, the need for a retinopathy treatment will grow as more than 438 million people are expected to suffer from diabetes by 2030. A study published this year by Oxford University predicted that eight out of 10 men and almost seven in 10 women will be overweight or obese by 2020. It forecast a 98% rise in obesity-related diabetes by 2050.

Alan Lamont, director of sciences and technology alliances at AstraZeneca. said: "We're getting very keen on the whole area of regenerative medicines and they will be part of our research development over the next few years." He said the collaboration aimed to come up with a treatment that could be administered to the back of the eye to repair damage locally.

AstraZeneca's US rival Pfizer also has a partnership with Professor Pete Coffey of the UCL Institute of Ophthalmology, for another eye condition, macular degeneration. Coffey said: "It's great that 'Big Pharma' is considering regenerative medicines as a serious possibility." He added: "This is British science being developed into a commercial entity with the pharmaceutical industry. It's a good example why the government shouldn't cut funding for biomedical research."

While this is the first time that AstraZeneca has worked on medicine for retinopathy, diabetes has been an area of focus. The company has a new diabetes treatment on the market called Onglyza, which was developed with Bristol-Myers Squibb, and the companies are developing a second diabetes drug that could be submitted to regulators for approval later this year.

Federal stem cell ruling blocks Yale scientists

By Rachel Gilmore

For two decades, Lawrence Rizzolo, the director of medical studies at the Yale School of Medicine, has been working toward a project that aims to transplant young, healthy retinal cells to replace diseased tissues in the eyes of patients who are going blind.

But now Rizzolo fears he may have to delay, or even stop, his research because of last week’s ruling by a federal judge that prevents federal funding for studies involving embryonic stem cells, the building blocks for human organs and tissues that Rizzolo needs for his project.

Rizzolo had applied for a grant from the National Institutes of Health to replace his funding from the nonprofit International Retinal Research Foundation, which ends in December. Rizzolo also has a three-year state grant from Rocky Hill, Conn.-based state holding company Connecticut Innovations, but he says he cannot continue his research without the federal funding.

Rizzolo’s laboratory is one of about a dozen facilities on campus that use stem cells. Haifan Lin, director of the Yale Stem Cell Center, said he did not yet know how the moratorium will affect Yale researchers.

“We’re all waiting for clarification on the implications of the judge’s ruling,” University President Richard Levin said.

But frozen funding could lead scientists to lose their jobs. Rizzolo said that although a fourth researcher will join his laboratory in October, he may soon have to fire his workers because the grants and not the University pay for his researchers’ salaries.

Although the U.S. Department of Justice has filed a motion seeking to delay the federal judge’s ban on funding, the relief would only be temporary, NIH spokesman Don Ralbovsky said. The Justice Department declined to comment Thursday.

Opponents of embryonic stem cell research have hailed the ruling.

“The American people should not be forced to pay for experiments — prohibited by federal law — that destroy human life,” said Steven Aden, the legal counsel for the Alliance Defense Fund, which advised the party that brought the lawsuit to court.

Most labs at Yale’s Stem Cell Center are supported primarily by state funds, which are not affected by the ruling, said Diane Krause, the center’s assistant director. But, she explained, those state grants were meant to be a springboard for acquiring federal funding.

“Discontinuation of NIH funding of work with human embryonic stem cells could be a disaster,” she said.

School of Medicine Dean Robert Alpern agreed, saying that halting the stem cell research would be a “loss to society.”

Krause and other Yale researchers met Aug. 26 with Connecticut attorney general and U.S. Senate candidate Richard Blumenthal LAW ’73, who told the News this week that he plans to file a brief in support of the appeal.

“It is incredibly important for our scientific and legislative leaders to come together and solve this issue quickly,” Blumenthal said in a statement. “We have already lost so many years of work to backwards-looking and bureaucratic federal policy.”

Linda McMahon, his Republican challenger for Chris Dodd’s Senate seat, also supports stem cell research, according to her website. The McMahon campaign did not respond to multiple phone requests for comment this week.

Even if the Justice Department successfully delays the ruling, NIH has not said whether it would accept new applications. That would be a problem for Yibing Qyang, an assistant professor of cardiology at the School of Medicine who currently has a $95,499 federal grant and had planned on applying for another in October.

“I cannot live without federal funding,” said Qyang, who is priming stem cells to become healthy heart cells in patients with heart disease.

Yale has received at least $17 million in state funding from a $100 million stem cell research pot funded in part by tobacco taxes. It also received $4.9 million in NIH stem cell research grants in 2009 and 2010. NIH gave $123 million to researchers in fiscal year 2010 for embryonic stem cell research, Ralbovsky said.

Rizzolo studies eye tissues called retinal pigment epithelia. Many eye diseases — including macular degeneration, from which more than 10 million Americans suffer — affect these tissues, which function as a support for the retina, the part of the eye responsible for sight. Doctors have tried to transplant retinal and epithelial cells to combat these diseases. But most of the transplants fail because they are risky and the patients who choose to undergo them are usually almost blind. Patients in the early stages of macular degeneration are unlikely to attempt a transplant; Rizzolo said he hopes that his research with stem cells, which he started to use about a year ago, would lead to other, less risky, treatments for the disease.

Rizzolo added that, in the past year, two Yale colleagues had entirely shut down their stem-cell research labs because of funding shortages.

“It’s pretty frustrating when you work so hard to see something go unfunded for political reasons,” he said.

The Yale Stem Cell Center, established in 2006, brings together more than 30 faculty members across the University.

International Stem Cell Corporation Formalizes Stem Cell- Based Eye Care Programs Into Cyovis

Article Date: 22 Aug 2010

International Stem Cell Corporation (OTCBB:ISCO), announced that its stem cell therapeutic programs focused on protective, transparent corneas (CytoCor™) in the front of the eye and the light-sensitive retinal tissue (CytoRet™) in the back of the eye will be formalized into a new business unit, Cytovis™. Together these programs will leverage external and internal development, regulatory and commercial expertise in cellular ophthalmology to form a focused portfolio of complementary product candidates designed to address high unmet medical needs with apparent pharmacoeconomic and quality of life benefits.

CytoCor is the brand name for ISCO's corneal tissue that can be derived from the company's proprietary parthenogenetic stem cells or commonly used embryonic stem cells. Research and development with partners Absorption Systems in the US, Sankara Nethralaya in India and Automation Partnership in the UK continues for the purpose of optimizing the tissue for transplantation in the 10 million people worldwide suffering from corneal vision impairment and as an alternative to the use of live animals and animal eyes in the $500+M market for safety testing of drugs, chemicals and consumer products. ISCO's goal in the coming months is to establish funding and infrastructure in India for accelerated development of CytoCor for the therapeutic application and to advance and implement the chemical testing application with partners in the US and Europe.

CytoRet is the brand name for ISCO's stem cell-derived retinal tissue. ISCO is using its parthenogenetic stem cells to develop individual retinal pigmented epithelial ("RPE") cells and layered retinal structures internally and in collaboration with the laboratory of Dr. Hans Keirstead, Professor of Anatomy and Neurobiology at the University of California, Irvine. ISCO recently commenced a new research collaboration with UC Irvine to launch the next phase of its retinal studies with that institution, including preclinical trials. Potential therapeutic applications include retinitis pigmentosa, an untreatable inherited disease affecting about 100,000 Americans, and the dry form of age-related macular degeneration, a major cause of blindness in the elderly of the Western world. ISCO's goal is to establish functional proof of concept for RPE cellular therapy in models of human disease in the next twelve-eighteen months.

Jointly referred to as Cytovis ("cyto" for cellular, "vis" for vision), these two cellular ophthalmology programs share a number of features and benefits. First, with the aging of the population worldwide and the growing number of work-related eye injuries in India, China and other major countries, the market opportunity is growing steadily. Second, there are strong pharmacoeconomic and quality-of-life rationales for full or partial vision restoration or delay of vision impairment diseases. Third, delivery of cells and tissues to the confined anatomy of the eye inherently provides for better safety and efficacy than, for example, the systemic circulation or the central nervous system. This will likely result in lower regulatory barriers and shorter and less costly development paths compared to that of anatomically deeper and more widespread diseases. Fourth, a number of eye diseases cannot be treated with surgery or traditional small molecule or protein therapeutics, yet cell and tissue therapy is proven to work but currently limited by availability of safe and sufficient cells and tissue from human donors. Finally, eye care development programs like CytoCor and CytoRet share a number of regulatory, development and commercial aspects that make it feasible for a relatively small team to produce substantial clinical outcomes and achieve competitive presence in the marketplace alone or in collaboration with dedicated partners.

Brian Lundstrom, ISCO's President, says: "ISCO's proprietary parthenogenetic stem cell technology continues to form the foundation for the company's long term regenerative medicine therapy programs. In the nearer term, CytoCor and CytoRet's unique benefits in the field of cellular ophthalmology offer the potential for partnering and funding at a relatively early stage. Combined with the current and future revenue of Lifeline Cell Technology and the revenue potential of Lifeline Skin Care, scheduled for launch in the 4th quarter, Cytovis adds significantly to ISCO's diversity and value creation potential for its investor base in a cost-efficient fashion."

Source:
International Stem Cell Corporation

Macular Degeneration and Heavy Metals

By Jannette Barrett

What Is Macular Degeneration?

Macular Degeneration is a condition that affects the macula part of the retina of the eye resulting in a disturbance to central vision. Although the exact etiology of the disease is unknown, it is believed that deterioration of the retina leads to a breakdown in the transmission of signals to the brain from the nerves and receptors of the eye. When the signals are unclear, the brain cannot correctly interpret the information it receives and there is a loss of the detail that allows us to read, recognise people, perform manual work or manage fine tasks such as threading a needle. A person with macular degeneration may experience blurred or decreased central vision, blind spots, wavy lines instead of straight and size distortion.

There are two types of macular degeneration, wet and dry.

The onset of wet macular degeneration occurs when abnormal blood vessels, which have grown under the centre of the retina, bleed or leak and scar the retina. Macula damage may occur rapidly. It is not uncommon for wet macular degeneration to start in one eye and effect the other at a later time.

Dry macular degeneration, which is the most common form, results from a gradual breakdown of cells in the macula leading to blurring of central vision. The onset of dry macular degeneration can be detected early by an optometrist because of the presence of small, yellowish spots, called drusen, at the back of the eye. However, people who have drusen, may not have visual impairment or related symptoms. When dry macular degeneration advances due to damage to the retina and nerves, vision loss will occur.

Macular degeneration is treated by laser surgery, photodynamic therapy where a drug is injected that destroys newly formed, abnormal blood vessels or injections, however, none of these treatments can restore the vision that has already been lost.

Risk factors

There are a number of identified risk factors associated with AMD. Family history and age are thought to be the most common risk factors. People with outdoor occupations and continuous exposure to sunlight may also be at risk, particularly if their skin is lightly pigmented. Women seem to be at a greater risk than men. There are also environmental and behavioural factors such as smoking and obesity. Research cited below shows that a build up of toxic heavy metals can damage eye health.

Research

The National Institute of Health and the National Eye Institute in the US, published the results of a random study of people with moderate and advanced AMD in the Archives of Opthalmology in 2001, entitled the Age-Related Eye Disease Study. The study reported that a significant slowing of disease progression and preservation of sight could be achieved by taking dietary supplements containing high-dose antioxidants and zinc.

Research published by Erie et al in 2005 in the American Journal of Opthalmology, measured the concentration of toxic heavy metals in the fluids and tissues of human eyes. Concentrations of lead, cadmium, mercury, and thallium in ocular tissues, ocular fluids, and blood were found in the autopsy of 30 eyes from 16 subjects. The study concluded the presence of lead and cadmium which had accumulated in the tissues and retinal pigment epithelium and choroid. Further study into the toxicity of these heavy metals and their possible role in eye disease was recommended.

What Can We Do?

In addition to the medical treatments mentioned above, there are a number of common sense things we can do to help prevent the onset of macular degeneration.

In order for high-dose antioxidants and zinc to be effectively absorbed into the body and to protect the eyes from heavy metals, it is firstly essential to detoxify the body. Published clinical trials have shown that when removing heavy metals and toxins, including pesticides and herbicides from the body safely and effectively, supplements will be more readily absorbed, the immune system may function more efficiently and normal blood pressure may be more easily maintained. Eating a healthy diet, including green leafy vegetables and fish, is also essential to good eye health. A healthy diet will help with weight control as will some regular exercise. Giving up smoking is critical for eye health.

Some people also believe in the benefit of eye exercises to increase eye health. Firstly move the eye slowly from side to side, then from top to bottom a few times. Move the eyes in a circular motion, then reverse a few times. Finally, raise your finger level with your nose and focus there for a time, then focus on something in the distance.

Remember the most important step, to take a daily detoxifying shower on the inside to give your eyes the maximum chance for sustained health. Your body will love you!
Author Resource:- Jannette has researched health and well being issues for the past 20 years and holds a Bachelor of Applied Science in Health Promotion. Healthy eating, regular meditation, moderation in everything and taking the correct supplements can make an enormous improvement to the quality of our lives.

The Best 9 Omega-Fish Oil Benefits

“A huge amount of studies show that, not only are the benefits of fish oil numerous, many of them are really very amazing! It seems sometimes like new research is being produced all the time, as researchers and physicians learn even more about how and why it is indeed effective. The omega-3 fatty acids found in fish oil are “good fats” that are vital to health. They are crucial for our health but our bodies can’t produce them – you have to get them through diet.

Here are some proven fish oil health benefits that should convince you to eat more oily, wild-caught fish and begin taking a highly refined fish oil supplement in the event you’re not at present!

Reduces Pain & Inflammation

Omega-3s possess a great anti-inflammatory impact. Research trials suggest that diets rich in omega-3s (and low in the pro-inflammatory omega-6s) may benefit people with inflammatory conditions — anything that ends in -itis!. Omega-3 additionally has been used to effectively treat neck, back and menstrual pain, allowing study patients to cut down their particular consumption of NSAID medication.

Promotes Heart Wellness & Protects Against Heart Attack and Strokes

Fish oil continues to grow in research reputation as a key promoter of heart health. According to the American Heart Association, fish oil is effective in lessening the incidence of heart disease and aids in reducing risk factors such as high cholesterol and high blood pressure. Research studies of heart attack survivors have discovered that daily fish oil capsules drastically minimize the risk of death, additional heart attacks and stroke. Omega-3s also reduce blood triglycerides, help correct irregular heartbeats, and can help prevent and treat atherosclerosis by preventing the formation of plaque and blood clots, which typically clog arteries.

Ensures Healthy Joints and Reduces Arthritis Symptoms

The omega-3 fatty acids in fish oil reduce tenderness in joints, pain intensity and morning stiffness caused by rheumatoid arthritis. In fact, several test tube studies have shown that omega-3s actually lessen the action of enzymes that break down cartilage. More than 13 published research trials have shown that fish oil supplements are very effective at treating rheumatoid arthritis. Fish oil has helped those suffering from RA to reduce their need for pain medicine.

Supports Happy Mood & Emotional Wellness

In nations where fish makes up a significant part of the diet, nationwide rates of depression are lower. So, it’s not surprising that studies have shown that fish oil capsules can alleviate the symptoms of depression, bipolar disorder and psychosis. Numerous clinical trials have found that participants that took omega-3s in addition to prescribed anti-depressants had a larger improvement in symptoms than those who only took antidepressants, with subjects experiencing a stabilizing effect and less mood swings. Studies have also demonstrated that, when prisoners were administered omega three fatty acids, there was a significant drop in hostile behavior. Omega-3s also appear to lower the risk ofpostpartum depression.

Enhances Mental Focus & Long-Term Cognitive Functioning

Did you know that omega-3s, especially DHA, are highly concentrated in our brains? They’re important for optimal cognitive (brain memory and performance) and behavioral function, as well as normal growth and development. Studies demonstrate that omega-3s may help in maintaining adequate cognitive functioning and possibly in avoiding or delaying the onset of Alzheimer’s disease. We also now know it’s incredibly necessary that pregnant women get adequate DHA, which is required by the developing fetus — during the third trimester of being pregnant, the brain of the fetus grows at a rate of a quarter million new neurons every 60 seconds! Children are also aided by omega-3 intake, as many studies show that omega-3s enhance learning, concentration, reading and vocabulary skills. Countless studies have even shown benefits in treating ADD.

Promotes Vision Wellness

Studies show that people with a greater omega-3 consumption appear to have a decreased risk of Dry-Eye Syndrome and developing AMD, or age-related macular degeneration. Early research also shows that fish oil supplements aid in lessening dry eye symptoms, may help to slow macular degeneration for those already developing it and improves ocular health in general.

Pregnancy, Infant Brain/Vision Development & Reduced Incidence of Childhood Disorders

DHA makes up 15-20% of the cerebral cortex and approximately 30-60% of the retina, so it’s absolutely necessary for normal growth and development of the fetus and baby. Prenatal DHA availability also seems to reduce the chances of childhood allergies and have an effect on motor skill quality, cognitive development and hyperactivity/behavior later in the child’s life. Omega-3s also assist in reducing the risk of low birth weight and premature birth.

Enhances Metabolism of Fat and Weight Loss

According to the National Institute of Health, omega-3s transmit “I’m full” signals to the brain and help quash hunger signals. Research has also shown that omega-3 fish oil improves the effectiveness of exercise in reducing weight. Volunteers who were alloted fish oil with their diet showed greater weight loss as compared to those who didn’t consume fish oil. Exercise along with fish oil had a positive effect on the body shape and body composition of the volunteers. Reduces Risk of Prostate, Breast & Colorectal Cancers Though more research in this area is certainly needed, we now know that the omega 3’s that appear in fish oil assist in the prevention and treatment of testicular, prostate, breast and ovarian cancers. Preliminary studies suggest that taking fish oil everyday can help inhibit the progression of colon cancer in people with early stages of the disease and may even have the capacity to cause apoptosis (cellular death) of cancer cells.

More can be written with regards to the many fish oil benefits. And, as the scientific community and doctors continue to examine omega-3s, you can bet that fish oil will keep making headlines as the ideal source of these essential fatty acids that are so essential to our bodies. Even if you’re currently in great health, a quality fish oil supplement is the fastest, safest way to realize and maintain optimal health!”

Artificial Retina offers new Hope

TUCSON - There is new hope for millions of people losing their vision. Many are going blind because of age-related macular degeneration and other conditions. But a new device called Artificial Retina has people seeing and believing.

Dean Lloyd is one of 14 people in the United States seeing through an Artifical Retina. He lost his vision in 1974. Lloyd says, "I almost lost all my vision in six months." Then in 2007, after a three hour operation, his sight, though limited, returned. "The beauty of the human brain is when you've had sight at one time, the brain seems to save the images," he said.

The camera on Dean's glasses captures an image and sends it wirelessly to an implant in his eye that stimulates his optic nerve to create an image in his brain. The next generation for Dean's implant is one that could help him see details and faces.

Satinderpall Pannu heads the Artificial Retina project at Lawrence Livermore labs in California. Starting with a silicon wafer and a thin coating of polymer, the disk is processed, electrodes are added and the implant is encased in titanium and gold, "It's a very rewarding feeling. It's amazing to me that technology that we've developed here at the lab can actually restore someone's sight," Pannu said.

Pannu says in 10 years, 50 million people in the world will suffer from blindness that these implants could reverse, "We really would like to take this tech to have a digital camera embedded in your retina and be able to restore your vision completely."

The only clinical trials for the artificial retina in the U.S. are run through a California Company "Second Sight."

Project leaders at Lawrence Livermore say they only have funding through next year. Right now, they're trying to lobby congress to extend the project's 8-million dollar a year budget, to improve the implant.

Alimera seek NDA for diabetic macular degeneration drug/device combo

June 29, 2010 by MassDevice staffpSivida Corp. and Alimera Sciences file a new drug application with the Food & Drug Administration for Iluvien, a drug/device combination aimed at treating diabetic macular degeneration.

pSivida Corp. (NSDQ:PSDV) and Alimera Sciences (NSDQ:ALIM) are seeking a green light from the Food & Drug Administration for a drug/device combination to treat diabetic macular degeneration.

Watertown, Mass.-based pSivida said Alimera, which licenses the Iluvien technology from pSivida, submitted a new drug application to the FDA. The technology is designed to deliver sustained, low doses of flucocinolone acetonide to the retina at the rear of the eyeball.

Alimera asked the federal watchdog for priority review, an expedited process that could bring an FDA response during the fourth quarter, according to a press release.

There are no approved drugs to treat DME, according to pSivida president and CEO Paul Ashton, adding that Iluvien is the company's third product aimed at back-of-the-eye diseases. The first two won FDA approval and are on the market, Ashton said: Retisert, for the treatment of posterior uveitis, and Vitrasert for the treatment of AIDS-related cytomegalovirus retinitis. Both are licensed to Bausch & Lomb Inc.

The company is also working on a treatment for retinitis pigmentosa, which involves the gradual deterioration of the rods and cones that make up the retina. In April Ashton told MassDevice that its Durasert device also uses flucocinolone acetonide, a steroid, to treat the disease.

"What we've done is use a very small insertable drug delivery device to release a steroid directly into the eye that will just provide some protection and slow down the rates of vision loss," he said. "With a condition that takes 20 years to make you blind, if you slow it down by a factor of two, that's pretty good."

The partnership with Alimera has already paid dividends, namely a $15.3 million payment triggered by Alimera's April 21 initial public offering. At the time Ashton told us pSivida planned to use the cash to further develop its product pipeline. If the FDA gives the nod to Iluvien, it would trigger another, $25 million milestone payment from Alimera, plus 20 percent royalties on net profits from sales of the treatment.

For more information go to www.maculardegenerationassociation.org