Stem Cells in Ophthalmology Update 13 Advanced Cell Technology Update

In the wake of the 60 Minutes expose of illegitimate stem cell activities, I thought I would bring you good news about a couple of  legitimate, government approved clinical trials using stem cells.

As part of the Biotech Showcase 2012 conference program, being held in San Francisco, ACT company chairman and CEO, Gary Rabin will present talks on his company’s progress as part of two panels at the Regenerative Medicine State of the Industry Briefing. In advance of his two talks, the company released a statement about the ongoing clinical trials, results and timing, on his From the Chairman company blog.

In his statement, reproduced below, Rabin commented on the progress of two of the three government approved clinical trials currently underway at UCLA’s Jules Stein Eye Institute on treating Stargardt’s Macular Dystrophy and the dry form of age-related macular degeneration (Dry AMD). (See Update 8 and Update 9 for additional information.) (The other clinical trial, also for treating Stargardt’s, is taking place in the UK at Moorfields Eye Hospital in London.[Update 10])

As I reported last July, in Update 9, the first two patients in each of the UCLA trials were treated on July 12th. Since these are safety studies, the investigators are carefully watching the first patients response to the treatment before treating other patients in the twelve patient trials.

Rabin stated, “As you are no doubt aware, the trials at UCLA are being conducted by Dr. Steven Schwartz of JSEI and overseen by our chief scientific officer, Dr. Robert Lanza. Each patient has received an injection of 50,000 hESC-derived RPE cells in one eye. Both trials will involve twelve patients, and are designed to evaluate the safety and tolerability of the injected RPE cells. Based on the results of the first patient in each study, we are authorized by the Data and Safety Monitoring Board (DSMB) to move forward with the next two patients in the studies, each of whom will also be treated with 50,000 RPE cells.” (Emphasis added by editor.)

Rabin went on to say, “I am delighted to inform you that we are currently scheduled to treat our first patient in the UK at the end of next week or early the following week, and that we will be treating four additional US patients beginning that same following week.”

As for publishing the results of the studies, he said that the company would take the appropriate approach of “publishing it in the form of a paper in a prestigious, peer-reviewed medical journal. However, the peer-review process takes time. The process typically takes several months, so I am actually quite thrilled that we are now moving toward the final stages of completing it, less than six months after the first patients were treated. We are far enough along that at this point the additional waiting time will be measured only in weeks, not months.”

So, this is good news for the cell stem treatment of retinal diseases.

I have also just learned about several other clinical studies now underway in this field and will discuss them in a followup report (Update 14) to be published either later today or early tomorrow.

Now, here is the complete statement from Mr. Rabin, as taken from his company’s website:

January 10, 2012

Clinical Trials, Results, and Timing

Greetings,

For many of us, the New Year is a time not just for looking forward but for reflecting on events, achievements and lessons learned over the past year. I anticipate an amazing year ahead for ACT, and at the same time I also cannot help but reflect with pride on how far the company has come with its clinical programs over the past year.

IND Filing and Clinical Trials

I will never forget the moment I learned that the company's Investigational New Drug Application (IND) for its human clinical trial for Stargardt's Macular Dystrophy (SMD) had been approved by the FDA. It was clear then that ACT truly was on the road to potentially making medical history. So much has happened in the interim that it is hard to believe that happened only a bit over one year ago, in late November, 2010!

Shortly after that, our IND for Dry Age Related Macular Degeneration (Dry AMD) was also approved. The brief time since then has been a whirlwind of activity in preparation for the clinical trials, and we were enormously pleased and proud to start them in July, at the first site, UCLA's Jules Stein Eye Institute (JSEI).

As you are no doubt aware, the trials at UCLA are being conducted by Dr. Steven Schwartz of JSEI and overseen by our chief scientific officer, Dr. Robert Lanza. Each patient has received an injection of 50,000 hESC-derived RPE cells in one eye. Both trials will involve twelve patients, and are designed to evaluate the safety and tolerability of the injected RPE cells. Based on the results of the first patient in each study, we are authorized by the Data and Safety Monitoring Board (DSMB) to move forward with the next two patients in the studies, each of whom will also be treated with 50,000 RPE cells.

Part of what makes research and development in the regenerative medicine sector so exciting is that it involves sailing into largely uncharted waters. ACT's two trials are the only ongoing human embryonic stem cell-based trials, period. We are quite literally creating a new area of medicine. This means there is tremendous pressure on us to "get it right." The responsibility to provide the first-ever validation for this enormously promising new sector rests entirely on our shoulders.

I hope, then, that our many fans and followers can understand why this process takes some time. All eyes are on us, both from the standpoint of support and scrutiny. Should our trials succeed, it could provide the validation that the regenerative medicine sector has been in need of for some time. This is why, in every stage, we are bending over backwards to make sure we cross all our t's and dot all our i's. As the saying goes, Rome wasn't built in a day. If we can successfully complete these trials and bring these therapies to market, though, the potential benefits would be manifold:

*  The potential to at least partially restore sight to millions of people suffering from Dry AMD, the most common cause of blindness for people over age 55.

*  Provide a much-needed validation to the entire regenerative medicine sector.

*  Provide an enormously useful base of scientific knowledge on which we and others can develop other treatments and cures.

*  Last but not least, reward our investors for their patience and support with a return on their investment as befits a company with the only approved treatment for Dry AMD, which has a potential market size of $25-30 Billion in the US and Europe alone, as well as for SMD.

For many years, I was an equity market investment manager. That is an industry where you can evaluate results on a daily basis. Just because you can do that, though, does not mean that you should. The best investors, by far, look at long-term investment opportunities. Running a biotech company is not the same. I am well aware that we have many shareholders who want to know why we don't just treat patients and release results as fast we can, and as fast as available. To do so would be beyond foolhardy for a company like ACT. If there is anything this industry has had some issues with, it is credibility in the mainstream healthcare world. We plan to change that. But to do that, it can't happen overnight. Patient selection, clinical site selection, the timing of patient treatment, and unexpected non-ocular conditions of patients found in health screenings are among the major factors that impact patient treatment. Another factor in the timing of treating these new patients is that we will have at our disposal a new kind of three-dimensional retinal imaging technique, which has not previously been available. Believe me, the timing of patient surgeries has nothing to do with safety, efficacy or availability of suitable patients.

I know that many investors want us to go as fast as possible in treating patients. But there is a tortoise/hare effect here that I simply won't discuss now. I know that it is hard to be patient, but we are making every decision for the best interest of the company in the long run. We don't get bonus points for finishing the trial a few months earlier as compared to making it a truly game-changing medical opportunity. I know that many of you don't know me from Adam, but I'm a very methodical person. Look who we recently added to the Board - one of the leading scientists in the world; one of the best entrepreneurs in the world (founder of Life Alert and eFax), and the CFO of a highly-regarded biotech company considered to have made excellent, value-preserving large bio/pharma partnering deals. We have this under control.

One ill-conceived decision could set the company on a downward path (ACT has been there). Highly prestigious peer-reviewed medical journals do substantial review and due diligence. Top-rated eye hospitals and surgeons are very process-oriented and sometimes bureaucratic. Pushing them harder to move faster doesn't earn you any credibility or success.

Nevertheless, I am delighted to inform you that we are currently scheduled to treat our first patient in the UK at the end of next week or early the following week, and that we will be treating four additional US patients beginning that same following week.

Publishing Data

The question that inevitably comes up asks when we are going to publish the initial data from the trials. We are eagerly anticipating doing so but we are not going to just post it in raw form. This trial has the potential to make medical history and we want to share the initial results with the world in a strategic way.

The only appropriate approach with data this significant is publishing it in the form of a paper in a prestigious, peer-reviewed medical journal. However, the peer-review process takes time. The process typically takes several months, so I am actually quite thrilled that we are now moving toward the final stages of completing it, less than six months after the first patients were treated. We are far enough along that at this point the additional waiting time will be measured only in weeks, not months. We are coordinating the scientific publication with a general mainstream media release strategy (see below). When the paper is published, rest assured that we plan to leverage it to make sure it is very broadly known, not only in medicine, but in the broader medical and scientific community, as well as the investment community.

We sincerely appreciate everyone's patience as we continue this process. We are keenly aware that our investors, fans and other followers are anxious to see the data.

Thank you for your patience and thank you, as always, for your interest and support.

Gary Rabin

Chairman and CEO

Advanced Cell Technology, Inc.

Tips On How To Learn Advanced Massage Skills

By Tammie Caldwell

You have always wanted to become a massage therapist, you do understand that becoming one requires you to secure the right credentials and the appropriate background first. You are intent on becoming a successfully practitioner in the field. So, you are intent on finding the right school.

You need to secure a formal training if you really want to establish a career in the field. In this case, it is expected that you should learn advanced massage skills by signing up for the right program. Finding the right school is your main concern this time. Make sure that you do locate a good one.

Consider calling the Better Business Bureau. This office holds information about the reputation that these schools and institutions have established over the years. This is a good way to ascertain which among these providers around are expected to get you the right training you need.

You will need to find to right school where you are going to get trained at. There are certain requirements that you will need to meet first before you will be considered qualified for the job. Also, it helps to check the requirements that your state has set. In addition, find schools that are accredited.

Once you have found out several programs that could possibly get you the exposure that you need, it is important that you will check the actual course makeup. You need to see if this is the type of program that you are indeed looking for. Also, seeing things for yourself by visiting the campus is encouraged.

Consider the types of class work that can be expected if you will decide to take advantage of these lessons, you need to know is there is going to be proper theoretical discussions and then hands-on training to. You cannot expect to learn well about the program unless there is a balance between these two.

The credentials of the teachers that are handling these classes should be considered as well. Remember, the qualifications of these teachers that will be handling these lessons should be considered. You want to be sure that they have the right experience and background so they can assist you and instruct you right.

Consider the size of the cases too. Make sure that you will consider how many people are likely going to be attending these lessons for you. If you prefer a setting where you get to have less people to compete with for the instructor's attention, then to for a smaller class. Also, consider their modalities and techniques in teaching too.

Consider how much you have to spend to sign up for this course too. You want to set aside a budget that will help you pay for the tuition fees involved. You want to consider the expenses you are likely going to have to cover as far as books and supplies are involved. Also, know how much cash you have to set aside.

Accessibility is another factor too. Consider how close the place of to where you currently are staying, the closer it is, the easier it should be for you to get to the area. Also, see if they offer really good class schedules too, so you will not have a hard time attending them.

About the Author:

Learn advanced massage skills and become a certified therapist today. Come and sign up now using this useful source at http://erikdalton.com.

Benefits Of Advanced Skin Care Products

By Mark Campbell

Advertising and packing may be one of the reasons as to why many people end up purchasing products that do not work and end up regretting their actions later on. This is because most products will use fancy bottles or nicely designed labels to attract your eye and make you want to purchase the product whose content are not clearly visible. Instead of this opt for Advanced Skin Care treatments for results.

With the products, you may find them expensive at first, but later on, you will realize that they are cheaper. This is because with the product you are assured of quality results as opposed to the fake well marketed products. With the fake products, you will purchase them multiple times and still not achieve the desired effect thus making them more expensive in the long run.

With the complex products, the manufacturers will try to assure their clients of the capability of their products. They will do this through conducting research and tests of natural ingredients used in making the products. To ensure that they draw accurate conclusions, they will use the exact amounts of ingredients used to make the products while conducting the research.

To help ensure that it maintains its structure and plump look and feel, the body will produce some proteins that are used to offer support to the skins structure. The proteins important for the skins structure are collagen and elastin. When the body fails to produce adequate amounts of the proteins, the skins structure is weakened thus resulting in sagging and wrinkles.

To make a product that will handle this problem, the researchers will find a way to increase the production of the proteins so as to support the skins structure. To achieve this, most complex products will contain hyaluronic ingredients which promote the formation of the proteins. This will thus restore the skins structure and eliminate any sags and wrinkles on its surface.

Finally, the product is also manufactured in a way that allows it to penetrate into the skin layers completely. By allowing it to penetrate, the product will destroy free radicals on and in the skins structure which affects its health. The product will thus ensure it receives benefits both outside which are visible and inside which may not be as visible but also affects its appearance.

To further inform their clients of their products, most manufacturers will have company websites which will contain further information about the product and the ingredients used to manufacture it. Also, you can also check out the reviews made by users of these products so as to ascertain that the product is good for use. This is thus part of the research needed before purchasing a product.

In conclusion, research is the best way in which you can identify the best products that will improve the skins look and appearance. Do not be swayed into buying a product just because it looks appeasing as this will be your worst mistake that you will end up regretting. It is also important that you know your skins type as the products are specified for different people.

About the Author:

Find an overview of the advantages of visiting an advanced skin care clinic and more info about a reputable clinic at http://www.ouramazingmolecules.com today.

What is an Advanced Yoga Practice Rerun

by Nina

Year-Old Snow and New Snow by Philip Amdal

A number of years ago, I encouraged a close friend of mine, M, to join me in taking Rodney Yee’s advanced class. Even though she had a muscular, athletic, and stiff body that made doing super bendy poses difficult, if not impossible, I knew that she understood how to take care of herself in class, that she would adapt the poses for her particular body type and keep herself safe, so I wasn’t worried about the class being too hard for her. She was interested, however, she expressed some concerns about not being “advanced” enough for the class. I decided to discuss the matter with our teacher himself, feeling fairly sure of what he was going to say. But what he told me when I asked him if she was “advanced” not only took me by surprise but has stuck with me all these years, transforming my thinking about the asana practice in general. What he said was this:

“Of course she’s advanced enough. M does yoga more mindfully than any student I’ve ever seen.”

And here I’d been thinking that being advanced meant being capable of doing difficult poses, like 10 minute headstands or extreme backbends, at some level or another! But doing yoga “mindfully”—now, here was goal we could pursue for our lifetimes and no matter our level of physical capacity was, we would always have the the ability to go deeper and deeper into the practice.

I’m thinking about this today because I’m helping a new friend of mine adapt her practice to allow her to heal from an ongoing injury. It’s taken her a long time to even be ready to temporarily give up certain poses and ways of practicing, because she felt such regrets about excluding poses from her practice that she used to be able to do with such great enjoyment. 

But as Baxter mentioned in his post on Wristful Wrists: How to Keep Your Wrists Safe, sometimes rest is the best way to heal from an injury. So being willing to adopt mindfulness as a goal in the practice rather than achievement is a necessary element in being able to heal from an injury.

People who are aging may find themselves in a similar position, not necessarily due to injury but simply due to the physical changes that come along with aging. To be honest, I used to have what I sometimes call a “semi-fancy” yoga practice. But in the last few years, I developed arthritis in my right hip that makes it impossible to do seated poses that involve a lot of external rotation. Lotus and half lotus are now impossible for me, and seated forward bends and twists that require certain leg positions are painful and difficult. And I now need props in many of the standing poses now. Still there is no question I consider my practice more advanced these days than it was in the years when I regularly took the East Bay’s most “advanced” yoga class.

Subscribe to Yoga for Healthy Aging by Email ° Follow Yoga for Healthy Aging on Facebook ° Join this site with Google Friend Connect