Stem Cells in Ophthalmology Update 4 ACT Receives FDA Approval to Use hESCs to Treat Dry AMD

Advanced Cell Technology Inc., announced today that it  had received approval from the FDA to commence its clinical trial using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) to treat the dry form of age-related macular degeneration. 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 degeneration in the world. There are currently no approved 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, and a further 10 million Europeans.

Age-Related Macular Degeneration has two predominant forms, wet and dry. Dry AMD is the most common form, accounting for almost 90% 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 Gary Rabin, Interim Chairman and CEO of ACT. "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." (For both dry AMD and for treating Stargardt’s Disease, approval for which was obtained in November 2010.)

The Phase I/II 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," stated Robert Lanza, MD, ACT's 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, ACT's 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."

Shingles may lead to Stroke and Heart attack

Herpes zoster can cause shingles, a painful condition with serious complications

Herpes zoster, also known as shingles, is linked to increased rates of acute cardiovascular events such as ischemic stroke and myocardial infarction, or heart attack, according to research published in PLOS Medicine.

Herpes zoster is a common virus, affecting a million Americans each year, with potentially serious consequences.

The virus causes both chicken pox and shingles. Following chickenpox, the virus remains inactive, or dormant, within the body.

If it becomes active again, which can be after many years, it can cause shingles, a painful, blistering skin rash that can be complicated by prolonged, severe, disabling pain - a condition called post-herpetic neuralgia (PHN).

Shingles can appear at any age but particularly in people over 60, those who had chickenpox before the age of 1 year, or individuals with a weakened immune system.

 A person who has direct contact with the shingles rash and has not previously had either chickenpox or the vaccine can develop chickenpox but not shingles. However, chickenpox can be so mild that people do not notice it at the time; they may later develop shingles.

It is not yet clear why the virus suddenly becomes active again.

Increased cardiovascular risk after herpes zoster

Acute cardiovascular diseases (CVDs), including ischemic stroke and myocardial infarction (MI), are major causes of morbidity and mortality in the US. A better understanding is needed of what causes acute CVDs and how they can be prevented.

Acute infections are thought to lead to CVDs because of dysfunction within the blood vessels, in which plaques rupture in the artery wall, increasing the risk of blood clots.

In 2006, a targeted vaccination program for those aged 60 years or older was introduced in the US in an effort to prevent zoster-associated morbidity.

Caroline Minassian and colleagues from the London School of Hygiene and Tropical Medicine in the UK wanted to measure the short-term increased risk of stroke and MI after zoster, as well as the impact of zoster vaccination.

The team identified 42,954 Medicare beneficiaries aged 65 years and over who had a herpes zoster diagnosis and an ischemic stroke, and 24,237 beneficiaries who had a herpes zoster diagnosis and MI during a 5-year period.

The researchers then calculated the chance of having stroke or MI within 12 months of a zoster diagnosis, compared with times when the patient did not have the virus, known as the baseline period. They also adjusted for age.

Among those diagnosed with herpes zoster within the past year, there was a 2.4-times higher chance of an ischemic stroke and 1.7 times higher chance of MI in the first week after herpes zoster, compared with the baseline period. The risk decreased gradually over the 6 months following the herpes zoster diagnosis.
 
Ischemic stroke and MI incidence ratios appeared to be the same regardless of whether individuals had been vaccinated against zoster or not.

Limitations include the fact that major life events and stress were not taken into account, and that only a few participants had been vaccinated, thus reducing the ability to detect the effect of vaccination.
The authors say:

"These findings enhance our understanding of the temporality and magnitude of the association between zoster and acute cardiovascular events."

A previous study published by Medical News Today suggests that a higher rate of stroke is linked to shingles.

Written by Yvette Brazier

Friday Q A How Long to Stretch

Q: How long should I hold a stretch for maximum benefits? 

A: Before we answer this reader’s question, we will provide some background on flexibility and stretching in general. To start, let’s clarify exactly what we mean by “flexibility.” One definition that we like is: 

Flexibility is defined as the ability to move through a specific joint range of motion (ROM)

For example, good range of motion in the hip joint in a forward fold (flexion) means being able to fold your hip joint towards your belly to about a 160-degree angle when your knee is bent. If you discovered that your hip range of motion in this direction was limited to about 90 degrees—which would definitely restrict your ability to do some of your daily activities (such as bending your knee in to put on your shoes)—you might want to increase your range of motion/flexibility at that joint. Can stretching of the sort we do in yoga eventually improve your range of motion at the hip? Let’s start by looking at how stretching in general helps. 


How Stretching Improves Flexibility

Studies have shown that stretching increases muscle length (known as extensibility) and increases range of motion at the joints. The exact mechanisms that cause these effects are not clear yet but may include mechanical changes in the myofascial tissues and/or in the neural connections of muscles and brain, or in decreasing the intensity of sensation that deep stretch causes (called “stretch tolerance”).

The studies have also shown that improved range of motion at the joints and increased muscle length occur as a result of both static stretching and dynamic stretching. They also note that for younger people, a static stretch of 15-30 seconds may be adequate for both short- and long-term results of changing resting length of the muscle and improving range of motion of the joints, but for older adults over 65, longer holds may be needed, up to 60 seconds. In addition, the study on the muscle protein titin that we mentioned in Static Versus Dynamic Poses suggests that static holds of 90 seconds or longer may actually lead to better gains. All these finding have influenced our recommendations for how long to hold poses below.

Other studies on stretching to improve flexibility have shown that when performed regularly over a long period of time stretching improved flexibility in hamstrings, calves and ankles, as reflected by increased joint range of motion. Not so impressive is the finding that the effects of short-term stretching or infrequent stretching don’t last much longer than one day or so. So if you if you don’t stretch regularly, after a day or two, muscles return to pre-stretch length. But you can overcome this by doing “held” or static stretches three or more times a week—perhaps good motivation to have a regular home practice! 

Quite interestingly, long-term stretching regimens have actually been shown to improve performance in physical activities—from various sports to every-day physical activities—over time, as well as improving overall strength. How unexpected and fascinating that regular stretching can lead to improved strength! Although the mechanisms are complex and incompletely understood, passive and active stretching is thought to lead to muscle hypertrophy (growth). The results, however, are welcome! If you want to know more about it, see http://www.somastruct.com/stretching-a-form-of-strengthening/. 


Ways of Stretching with Yoga 

There are two main styles of stretching that yoga provides: dynamic and static. In dynamic poses, the stretches are very brief, as you move in and out of the stretch with your breath. In static poses, you hold the stretch for period of time, but that period can range from quite short (say, 10 seconds) to quite long (2 or 3 minutes or longer for restorative poses). How do you choose when to do which? 

If you are doing yoga stretches to improve your performance in other activities, such as running or some other sport, studies have shown that static, held stretches greater than 45 seconds can actually reduce performance right after stretching. On the other hand, dynamic stretching seems to have no negative impact—and maybe slightly positive impacts—on sports performance. So I’d recommend that you don’t do long static yoga stretches right before you head out for an hour of cycling or a long stint at the rock climbing gym. Save the static stretches for afterwards or put a day in between a good yoga practice and your other favorite physical activity. 

On the other hand, if your goal is to go further into more challenging poses that require better flexibility, we find dynamic stretches do lead to immediate improvements in muscle flexibility that we can then further with a static hold of the same pose. For example, moving dynamically in and out of Standing Forward Bend (Uttanasana) leads to improved hamstring/hip flexibility, which can then be increased even more with a long hold of the pose.  

How Long to Stretch? 

Finally, getting back to the original question: how long should you stretch for maximum benefit? Because of the research that shows the protein titin, which is found in muscles, changes shape and may contribute to a stretch lasting for several days when a stretch is held for longer periods of time, say 90 seconds (see Yoga and Flexibility: An Overview, we recommend a combination of small dynamic sequences of stretches done for 6-8 repetitions, followed by holding the stretch for 90 seconds. For example, if you are trying to stretch the fronts of your thighs (psoas and rectus femoris muscles), you could move dynamically from Extended Child's pose to Cobra pose and back for 6-8 rounds, and follow that by holding Cobra pose for 90 seconds. 

In general, with consistent practice, you can see results after at least three to eight weeks. As for how often and when you stretch, that depends on your goals: 

1. If you are taking up yoga to improve your flexibility and strength for a sport, such as running or rock climbing, which take advantage of both flexibility and strength, then do your yoga stretches, dynamic and static, on days other than your sport days. On your sport days, you could do dynamic stretches before the sports activity since they don’t negatively impact performance, but skip the static stretches.

2. If you are taking up yoga to combat the stiffening and tightening of your body from years of sitting at work, you can do your stretches anytime you want. As we always recommend, start out with a shorter daily home practice that you can do comfortably, and gradually add more time and challenge to your stretches as you advance. If you stretch a particular muscle or muscle group regularly, probably do it no more than every other day (we don’t want to overdo it and cause overuse injuries!).

3. If you are doing yoga asana regularly and your goal is to master more challenging poses, you will want to be consistent in stretching over several weeks to look for noticeable changes in flexibility. To give your body time to rest and repair, you will want to alternate intense stretching days with other types of yoga practice, whether that is an active, challenging practice, a gentle or restorative practice, or pranayama/meditative practice on your “off days.” 

Although we have tried to go in great detail here about what we know about stretching, we have no doubt there will be more to share in the future. So, until then, happy stretching! 

—Baxter and Nina

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Home Practice The Best Way to Improve Your Health and Well Being Rerun

by Timothy McCall

Bed in a Mirror by Nina Zolotow

"If you are taking yoga classes but not practicing at home, you may be missing the best—and potentially most therapeutic—part of yoga. Your personal practice is where the deepest work happens, when you go inward and go at your own pace."—from Yoga As Medicine

This quotation from my book got posted on Facebook the other day and generated quite a bit of interest. But not everyone, particularly those who only take classes, agrees with the statement. A woman came up to me at a yoga conference earlier this year to say she’d heard me make a similar comment at a workshop I taught in Los Angeles a few years ago, and it made her really angry. It’s easy to understand that reaction when your experience in class has been so positive, and even healing.

But now scientific research seems to back up the notion that a regular home practice really is the key to health and well-being, perhaps particularly so as we get older. A study recently published in the journal Evidence-Based Complementary and Alternative Medicine by researchers at the University of Maryland and the National Institutes of Health found that, among more than 1000 practitioners of Iyengar yoga, the frequency of home practice predicted positive health more than how long you’ve been practicing or how many classes you attend per week. According to the article Frequency of yoga practice predicts health: results of a national survey of yoga practitioners:

“Frequency of home practice favorably predicted (p < .001): mindfulness, subjective well-being, BMI, fruit and vegetable consumption, vegetarian status, sleep, and fatigue.” 

In other words, those who practiced at home the most reported better health and well-being, greater awareness of themselves and others, improved sleep, less fatigue, and healthier body weight. They were even more likely to eat their vegetables! 

The study bore out something else I’ve been teaching for years: when you combine the various tools in the yoga toolbox including asana, breathing practices, meditation and even study of yoga philosophy you tend to get even better results. As the authors put it, “an intense practice involving all aspects of yoga practice may be more beneficial to health than a less intense practice that includes only one or two aspects of yoga practice, such as just practicing the physical poses or breath work.”

There also appeared to be additional benefits for combining different types of asana practices, such as standing poses, vigorous practices like Sun Salutations, restorative poses including Savasana, and inversions like Shoulderstand. Different practices appeared to be particularly beneficial for specific conditions. Vigorous asana and inversions seemed to help the most with insomnia and body weight, whereas, according to the authors, “because breath work and meditation appear to influence mindfulness and well-being, they may be particularly useful in treating conditions such as depression and anxiety.”

One finding that may be of particular interest to readers of this blog has to do with fatigue. Overall, older practitioners had less fatigue than younger practitioners, but both groups improved when they did yoga. But it appears to take less practice for older practitioners to experience improvements in energy.

As for the woman who was mad at me for saying that a home practice was more important than going to classes, she went on to say that, almost despite herself, she did try doing her yoga at home. Now she does it regularly and believes it’s the most important part of her practice. She thanked me profusely, though of course most of all she can thank herself!

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How to select a healthy diet plan for grade 1 fatty liver illness

By Charles Rodriguez

Grade 1 fatty liver If neglected, the surplus building up of fat can injure your liver. That explains why an efficient diet plan is excellent for grade 1 fatty liver condition the diet method should includes foods that can help improve your liver conditions and make you healthy. Among the most simple ways to reverse grade 1 fatty liver illness is eating a well balanced liver diet.

As you possibly know, grade 1 fatty liver is due to excessive blubber increase in your liver. Throughout the early phases grade 1 fatty liver sickness routinely has no signs. It is frequently found on a constant clinical test.

Many individuals don't directly feel the symptoms of grade 1 fatty liver you want to comprehend that too much fat buildup in your liver causes inflammation and swelling. That's when you start spotting the symptoms.

You can feel a burning pain or leaden ache, in your abdomen as your liver becomes inflamed and irritated. Swelling and swelling implies when grade 1 fatty liver is starting to become worse.

You could similarly experience other symptoms such as low grade fevers revulsion, and typically feeling worn out and fatigue.

Before Starting Your Liver Diet Plan For Grade 1 Fatty Liver.

It's highly important to understand how the liver of somebody plays a duty in our well-ness and wellbeing. The human liver has one or two functions like blood circulation and detoxification.

Our liver aids emulsify fat by breaking down massive fat globules into smaller sized ones, which are then broken down in addition by enzymes. Your liver helps and maintain your blood sugar level in your body. It similarly filters out compounds and excretes the poisons in your piss. Finally your liver helps process the proteins and fats in the foodstuffs you eat.

Therefore , it's mandatory to remember that the sort of diet plan we eat as humans is the main aspect in grade 1 fatty liver condition. It's the secret to damaging or healing your liver.

Not so long ago, having a grade 1 fatty liver disease was thought on the point of being harmless, and progressed into a harsh wellbeing issue and life threatening condition. Nonetheless, many people have this illness and experienced issues like fibrosis and hepatitis. In one or two cases, these issues have become a unsafe condition that influence our wellness as people.

Supplements For Grade 1 Fatty Liver Additions.

There is a supplements called Omega-3 it's been study by health institutes that these omega 3 additions can avoid a range of nourishment related conditions like grade 1 fatty liver and cardio illness or adhd. Current studies disclose that fish oil can likewise ease grade 1 fatty liver condition which troubles a significant range of people who fight with non-alcoholic fatty liver condition. Grade 1 fatty liver disorder is not caused by excess alcohol use, though it's not unusual for alcohol drinkers to experience this illness. Rather, non-fatty liver condition is hooked up to a high level of triglycerides and low amounts of omega-3 fat in the diet.

About the Author:

My name is charles Rodriguez I've been helping folk naturally reverse their fatty infiltration of liver for over 10 years. In that time i have gained a huge quantity of knowledge on the subject of the most highly effective strategy for remedying simple enlarged liver symptoms . As a proponent of natural health and well-being, it's my goal to help anyone who would like to permanently reverse their fatty liver problem.

5 Things My Husband Does to Help me Cope with OCD

1. Supports me, not the OCD. He is empathetic to my struggle and my pain, but he doesn't reassure me in order to keep the peace.
   
2. Uses his sense of humor to highlight the ridiculousness of some of my OCD fears. He doesn't mock me, but the OCD is fair game.
3. Stays curious about the disorder. He read Jonathan Grayson's book Freedom From OCD on my request. He's not a support group kind of guy, and he isn't interested in going to the International OCD Foundation Conference with me, but he does educate himself about OCD.
4. Encourages me to do exposures, and is willing to get involved. If I am obsessing about what task to do next, he'll suggest I flip a coin. In the rare cases that his ADD mind actually gets stuck on something, he'll try an exposure out himself.
5. Affirms my decision to see an ERP therapist, even though it's expensive, because he sees the progress I've made.
   

Bikram Yoga Discovering Its Health Benefits to The Body

There are many individuals who do yoga in order to boost not only their body's blood circulation and metabolism but also to relax and relieve their stressful minds. This new type of Yoga exercise popularly known as Bikram Yoga is an effective way of helping the body's blood circulation and accelerates healing. Enthusiasts of such Yoga exercise stated that they feel relaxed and calm after each session. A big improvement in their body's digestive function and balance implies that this kind of exercise can truly help them lose excess weight. Improving the body's natural power to heal and helping stimulate the brain are a few of the good results of Hot Yoga.

Some students of Bikram Yoga are former alcohol or drug addicts who've found the effective healing properties of such exercise. This kind of Yoga strategy is an ideal way to discipline the mind and body in order to eliminate harmful toxins brought on by ones addiction. Well-known to many as the Bikram Method, this kind of yoga exercise is composed of numerous exercise positions that have been confirmed to aid the body become stable thus improving the body's ability to heal.

The inventor of this type of yoga, Bikram Choudhury, began practicing yoga when he was only four years old. The new type of Yoga Bikram enhanced aids equalize your body by means of bending and streching techniques assisting the body to recover faster. Bikram yoga is generally preferred by individuals who have sustained minor or major injuries since it helps fast track their healing. It has even been proved beneficial for those suffering from bone fractures or those who're experiencing a heart condition. People who have asthma have also claimed that Hot Yoga helped ease their breathing when they suffer an asthma attack. By undertaking some of the Yoga exercises, they found that it helps relieve their breathing and relax their own minds.

Health professionals have warned students of Bikram Yoga to ease up on such workouts. Considering that Hot Yoga exercises let someone excessively sweat where they're prone to dehydration. However, enthusiasts and professionals have shrugged off the rumors by claiming that by just doubling up their fluid consumption prevents them from becoming dehydrated. Even professional players have testified that Hot yoga greatly helped not just in speeding up their recovery from injury but also in eliminating harmful toxins from their body and maintaining their weight. Hot Yoga students who have a heart condition or those having medication should talk to their physician before continuing with such Yoga exercises.

Players and professional dancers find Bikram Yoga useful in their weight loss and flexibility. Given that Hot Yoga aids in improving the muscles flexibility and strength, it helps professional dancers and professional athletes perform better in their game or on stage. Athletes have also found that Hot Yoga boosts their brain function and self-confidence to make them think straight and push their bodies to the limit. Performers and dancers found it useful with their concentration, grace and memory during performance. This is why most students of Bikram Yoga are professional dancers.

Finally, the best benefit that Bikram Yoga can offer to someone is weight reduction. The Bikram Method or exercise is known also as Hot Yoga since the students are inside a room where the temperature reaches approximately ninety degrees to aid stimulate their sweat. Given that a typical Hot Yoga session burns about 700 calories signifies that after a number of sessions one can normally see the outcomes. So by doing it about 3-4 times a week, it will be simple to drop a few pounds weekly so what more after a month of doing it.

About the Author:By Kathy C. Johnson

For additional resource about bikram yoga poses, visit http://bikramyogadallas.net

Addendum to White Paper on Corneal Sculpting

In the November 2005 issue of Cataract & Refractive Surgery Today, I wrote a letter about a previously published article on the 193nm wavelength lasers, in which I told how I became involved in ophthalmic lasers and refractive surgery. The letter references both the White Paper and also another report that I wrote some years earlier that is probably the first marketing report on refractive surgery. Here’s a part of that letter (and links to the two reports):

...I began writing (and consulting) about ophthalmic lasers in 1983, following the first approvals of the YAG laser for capsulotomies. I became intrigued with the laser’s capabilities in medicine and decided to become an “expert” in the field. Part of my learning experience was attending a Gordon Research Conference on Biomedicine in the summer of either 1984 or 1985; I can’t remember the year. At that conference, I met several of the pioneers working on the excimer laser, including Carmen Puliafito, Fran L’Esperance, Steve Trokel, Charles Munnerlyn, David Muller, and I am sure others. It was there that Munnerlyn first showed his infamous chart showing the ablation depth versus dioptric correction for various optical zone sizes.

After meeting the experts at the Gordon Conference, in December 1985, I was hired by Fran L’Esperance and Anthony Pilaro (Fran L’Esperance’s financial backer and the founder of the Duty-Free shops found at every international airport) to prepare a marketing report forecasting the potential of what I then called laser refractive keratoplasty. That report was finished in March 1986 and was used to raise the initial monies from Alcon Laboratories, Inc., to fund Taunton Technologies (which later became Visx Incorporated). The report is also the basis for the per-procedure fee that became the moneymaker for the companies involved. It was Tony Pilaro’s idea, and he asked me to incorporate it into my report.

In September 1989, I published a white paper titled, “The Evolution and Prospects for Laser Refractive Keratoplasty.” In it, I believe I coined the term corneal sculpting. I updated the report for publication in the March 1992 issue of Laser Focus World.