Stem Cell Trials To Begin For Stargardt’s Treatment

Advanced Cell Technology Inc. (ACT) announced Thursday the enrollment of the patients in the trials for Stargardt’s Macular Dystrophy (SMD) and Dry Age-Related Macular Degeneration (Dry AMD). The patients were enrolled at the Jules Stein Eye Institute at the University of California, Los Angeles.

ACT won approval by the US Food and Drug Administration in January to use human embryonic stem cells for treating macular degeneration, a common cause of vision loss. That followed FDA approval in November for scientists to test the stem cells to treat people with Stargardt’s Macular Dystrophy. The new trials will test the safety and tolerability of retinal pigment epithelial, or RPE cells, which ACT makes from the human embryonic stem cells.

Animal studies have reportedly shown that injecting fresh RPE cells into the eye could bring about a substantial improvement in eyesight. In other studies, scientists said mice with eye disease recovered near-normal vision after receiving the therapy.

In addition to the Jules Stein Eye Institute at UCLA, the Casey Eye Institute (CEI) at Oregon Health & Science University (OHSU) in Portland, OR, is also open for enrollment of patients with SMD.

As additional sites are ready to enroll patients with SMD and dry AMD, they will be listed on the Clinical Trials page on ACT’s Web site and at http://www.clinicaltrials.gov.

http://www.redorbit.com/news/health/2066060/stem_cell_trials_to_begin_for_blindness_treatment/

What’s Good for the Heart is Good for the Eyes

The following article was posted by Lauren Tappan. It was written by Maurie Hill for the Zoomed In blog.

At the Foundation Fighting Blindness™ conferences that I’ve attended so far, there are always inquiries about diet and dietary supplements and their connection with different eye conditions.  The common response is “what’s good for the heart is good for the eyes.”  As simplistic as that sounds, it’s actually an excellent answer, especially when speaking to groups of people who have a wide range of eye conditions.

Not only have we become so far removed from the food chain, but we are also constantly bombarded with so many fad diets and suspicious sounding claims.  This unfortunately leads to people not taking the advice above to heart (pardon the pun).  I heard someone the other day pick up a bag of candy in a store and brag to a friend that it’s fat free.  Does that mean my vision will improve if I eat candy corn instead of avocados?  And yes, I’m hoping that sounds ridiculous to you.

Last year my relationship to food and what I eat was completely transformed after reading “The China Study” followed by “In Defense of Food: An Eater’s Manifesto”.  I was stunned by the relationship certain foods have with many different diseases, even those not commonly attributed to diet.  It shouldn’t be so surprising that we are what we eat.  Would a car be as efficient, long-lasting, and repair-free when running on fuel it was not designed for?  The food we were designed and born to eat is the kind that will fuel the human body beautifully.

Then there is the question of dietary supplementation and eye disease.  This is where you better be confident of your diagnosis as I discussed in Knowledge is Power because what’s happening at the molecular level will impact your dietary choices.  Take Vitamin A for example, which is metabolically processed in the visual cycle to help provide light to the retina.   At my visit to Dr. Rafael C. Caruso at the National Eye Institute in 2009, I learned that Vitamin A may actually be a bad thing for those of us with Stargardt Disease.  Because we are not able to synthesize it well, it can leave an excess of pigmented waste deposits, causing poor vision.  Conversely, Vitamin A is widely considered to be beneficial for those with Retinitis Pigmentosa.

All I know for sure is that I’m watching and waiting for my home grown vegetables to start popping out of the garden.  I’ve got a menu depending on it:  zucchini soup with Thai red pepper, roasted veggies, avocado on whole wheat toast, and lots and lots of chili.  And sprinkled with a little old-fashioned exercise, it’s good for my heart, helps me sleep and definitely makes me feel better.  Even if it doesn’t improve my vision, it gives me enough energy to face my visually challenging day.  And on a less selfish note, I’m aiming to minimize my burden on our expensive health care system.  But for right now, I deserve just a tiny chocolate treat after all this typing.  Nobody’s perfect all the time – what’s the fun in that?

ACT gets FDA Approval for AMD Treatment Trial

Advanced Cell Technology, Inc. (“ACT“), a leader in the field of regenerative medicine, announced today that the US Food and Drug Administration (FDA) has cleared the Company’s 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 initiate a Phase I/II multicenter clinical trial to treat patients with Dry AMD, the most common form of macular degenerationin the world. There are currently no treatments available for this prevalent disease of an aging global population. Dry AMD, representing a substantial global market opportunity and afflicts between 10-15 million Americans.

http://www.news-medical.net/news/20110103/FDA-clears-ACTs-IND-to-treat-AMD-using-hESC-derived-RPE-cells.aspx

http://www.masshightech.com/stories/2011/01/03/daily8-ACTs-Dry-AMD-therapy-boosted-by-25M-funding-FDA-clearance.html

 

New Subretinal Stem Cell Treatment for Eye Disease

Ridgefield, CT (PRWEB) September 1, 2010
A new stem cell therapy is now available to eye patients using subretinal placement of adult stem cells. Patients with more severe eye problems may now have the opportunity to improve their sight and gain useful vision.

Dr Steven Levy is pleased to announce that The XCell-Center in Germany has begun a new treatment for eye patients using subretinal placement of adult stem cells for ophthalmic disease. Initial patients included an individual with Stargardts Disease, a type of hereditary retinopathy, and a patient with Age Related Macular Degeneration or AMD.

http://www.prweb.com/releases/2010/09/prweb4427444.htm

Low Vision Services in Cape Cod

This item is by Lauren Tappan:

Lauren and her husband Jay are enjoying a vacation traveling throughout the Cape Cod area. While on the Cape, she investigated the Sight Loss Services of Cape Cod.

Sight Loss Services Inc.
P.O. Box 414
81 School St.
West Dennis, MA 02670
(508) 394-3904
1-800-427-6842  (In Massachusetts Only)
email:Sightloss@Verizon.net

Their Statement of Purpose:

SIGHT LOSS Services, Inc., Cape Cod and Islands is a non-profit, human service organization offering peer support, information and referral, education and awareness, outreach, and home independence training to people who are learning to cope and function safely and independently with the loss of sight.

Our programs are geared toward helping to reduce the fears and isolation caused by the onset of vision loss and toward helping to simplify the mechanics of daily living.

Based on a “peer support and self-help” philosophy, SIGHT LOSS Services aims to foster an individual’s sense of self worth and independence and to point the way for him/her to help others. Our programs include:

* Self Help Support Groups

* Adaptive Aids

* Information and Referral

* Education and Awareness

* Outreach and Independence Services

Our geographic region of focus is Cape Cod, Martha’s Vineyard, and Nantucket. We have had inquiries from people all around the world.

In addition to the facilities at Sight Loss, the Eldridge Library in Chatham,Mass (Cape Cod) has two Clearview  CCTVs. As you may recall, Lauren volunteered to raise money and buy a CCTV for the Chapel Hill, NC library. They declined, saying they were not sure where in the library they would put it. Hmm! Storage triumphs over service.

For more info about Sight Loss Services:

http://www.jwen.com/sls/About.aspx

Emerging Technologies Successfully Stimulate Damaged Retinas

Scientific American article discusses the promise of emerging technologies to successfully stimulate retinas ravaged by retinitis pigmentosa or age-related macular degeneration.

Scientists have been working for decades to create an optical prosthesis that restores at least partial vision to those suffering from retinitis pigmentosa, macular degeneration and other retina-damaging diseases. Some retinal implants have begun to deliver on that promise, but the challenge remains for researchers to develop a technology that, in addition to providing clear images, can be worn comfortably over the long term.

Germany’s Retina Implant, AG, thinks it has made great strides in both areas, an assertion that will be put to the test later this year when the company launches its phase II human clinical trial, placing subretinal (under retina) implants in about 50 patients over the next few years. Meanwhile, Sylmar, Calif.–based Second Sight Medical Products plans to make its epiretinal (over retina) implants commercially available in Europe later this year. Researchers at the Massachusetts Institute of Technology and other institutions and medical technology companies are likewise developing retinal implants—the retina lines the eye’s inner surface and records images in patterns of light and color—but are not as far along as Retina Implant or Second Sight.

Retina Implant’s device is a three- by three-millimeter microelectronic chip (0.1 millimeter thick), containing about 1,500 light-sensitive photodiodes, amplifiers and electrodes that is implanted directly under the retina to generate artificial vision by stimulating inner retina nerve cells. The chip, which is placed in the retina’s macular region, absorbs light entering the eye and converts it into electricity that stimulates any still-functioning retinal nerves. This stimulation is relayed to the brain through the optical nerve.

http://www.scientificamerican.com/article.cfm?id=retinal-implant-vision

Foundation Fighting Blindness

For many years, people with retinal degenerative diseases such as retinitis pigmentosa (RP), Usher syndrome, and Stargardt disease have been frequently told by their eye care professionals that “there’s nothing we can do.”
Researchers funded by the Foundation Fighting Blindness are moving promising treatments and cures into human studies, and in the not-too-distant future, there are likely to be therapies that will enable eye care professionals to better treat many retinal degenerative diseases.

Over the past two years, more than 20 people who were nearly blind from a severe form of retinitis pigmentosa known as Leber congenital amaurosis (LCA) have had significant vision restored thanks to three landmark Phase I clinical trials of gene therapy. This breakthrough has received media attention and scientific accolades from around the world.

http://www.blindness.org/index.php?option=com_content&view=category&id=64&Itemid=120

Acupuncture and Macular Degeneration

Several studies have been reported throughout the world on the use of Acupuncture to treat wet and dry Macular Degeneration, Glaucoma, Stargardt’s  and Retinitis Pigmentosa. The acupuncture was done with and without electrical stimulation.

http://www.acudoctor.com/Results.htm

http://www.microacupuncture.com/

http://www.acudrved.com/u-programme.htm

http://www.reverseamd.com/

http://www.seniormag.com/conditions/vision/macular-degeneration.htm

Does anyone have any experience with this?

Did it work?

Please comment and advise.

Lauren Tappen writes:  I have tried current microstim not for any length of time. I have a friend who has been using this therapy extensively and I will pass on this information to her. I also know of a therapist in Raleigh that has been using the Microstim as a part of her practice.

Finding a Clinical Trial

The following is from Research Buzz:

Clinical research company Quintiles has launched Clinical Research at http://www.clinicalresearch.com, a Web site that, well, makes it easier to find clinical research.

The front page of the Web site asks you to provide the condition for which you’re searching and a location. If you enter something ambiguous (like “cancer”) the site will suggest topics. The location can be as narrow as a zip code, or a city (Madrid, Spain is one of the examples) or as encompassing as USA.

I did a search for autism in USA. I found 81 global studies but two within 150 miles of my stated point — one in Kansas City and one in Oklahoma City. When you look at the results for your search you’ll get a screen that looks like this:

You’ll notice that there are many ways to filter your search results — by age, gender, type of study, etc. — if you happen to get more than two search
results. Each map pointer has a brief amount of information about the study, but to get more data you’ll have to click on the title of a study, when the map will center on that study and present more context and additional details in a pointer bubble. You’ll also be able to get study contact information, find similar studies, or e-mail the study to a friend. (It kind of bugs me that you have to register to get study contact information.)

What you’ll find really depends on what you’re researching — I found one study of thyroid disorders, and that was in the context of breast cancer. When you review the available clinical trial studies please be sure to check the last time they were updated. Of the two autism studies I looked at, one was last updated in 2005. (The other was updated in the last week.)

The registration thing bugs me but this site has a lot of information and the search is easy to use. Worth a look.

Here is a sample:

http://www.researchbuzz.org/wp/find-a-clinical-trial/

Molecular Sunglasses for Macular Degeneration

Dampening a light-sensing reaction in the eye might slow a common cause of blindness. Molecules designed to slow the production of toxic byproducts in the eye by making it less sensitive to light are now being tested in patients with macular degeneration.

A growing pool of evidence suggests that the build up of specific compounds in the eye can hasten the cellular damage that underlies the disease. These compounds accumulate in the photoreceptors–cells in the retina that detect light–during normal eye function as the light-sensitive pigments in these cells change conformation in response to photons. 

One form of the photopigment, a derivative of vitamin A, is highly reactive and leaks into nearby tissue called the retinal pigment epithelium. “Over time we think these compounds are a burden for the retinal pigment epithelium, which is essential for the healthy function of the photoreceptors,” says Janet Sparrow, director of the Retinal Cell Biology Laboratory at Columbia University, in New York. “In age-related macular degeneration, particularly the dry form, these cells die, and the photoreceptors follow.”

While this reaction is vital for sight, researchers believe that slowing the cycle in the subset of photoreceptors responsible for night vision, known as rods, could slow damage without having a large impact on daytime vision.

One compound developed by Acucela that is in clinical trials inhibits the enzyme that converts the photopigment in photoreceptors from one form to another. This process happens only in the eye, allowing the drug to be administered systemically without affecting other tissue.

A second drug that acts by a slightly different mechanism is being evaluated for macular degeneration by Sirion Therapeutics, a Florida-based pharmaceutical company. The compound is a synthetic vitamin A derivative that is thought to reduce toxin buildup by binding to one of the proteins involved in the reaction. According to preliminary results from tests of the drug in patients with late-stage dry macular degeneration, it can slow the scarring that is characteristic of the disease by 45 percent. However, scientists won’t know if the results are statistically significant until completion of the study next year. Because no treatments have been approved for dry AMD, the U.S. Food and Drug Administration has fast-tracked the drug, speeding the review process.

http://www.technologyreview.com/biomedicine/23835/page1/