Stem Cells in Ophthalmology Update 28 First Ophthalmic Stem Cell Treatment Recommended for Approval

On December 19th, the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) recommended the stem cell product Holoclar (Chiesi Farmaceutici S.p.A.)  as a first-ever medicinal treatment for severe limbal stem cell deficiency, a condition caused by physical or chemical burns to the eye or eyes in adults, which can result in blindness.

The EMA has designated Holoclar as both an orphan medicine and an advanced therapy medicinal product, which enabled the manufacturer to receive free scientific advice and protocol assistance for drug development. The CHMP recommendation was based on an assessment by the expert Committee for Advanced Therapies. Such steps are taken to promote the development of medicines for rare diseases and to encourage innovative medicinal products, according to the EMA statement.

Holoclar is produced by Chiesi under an agreement with Holostem Terapie Avanzate, an Italian biotechnological company devoted to the development, manufacture, registration and distribution of Advanced Therapy products based on cultures of epithelial stem cells both for cell therapy and gene therapy. Holoclar was designed specifically for the treatment of severe limbal stem cell deficiency (LSCD).

The transparency of the cornea is essential to ensure the ability to see properly. Corneal cell renewal and repair are dependent upon the cells present in the limbus, which is found in a small area of the eye between the cornea and the conjunctiva.

Thermal or chemical burns to the eye can destroy the corneal surface (epithelium) and the limbus, causing a deficiency of limbal cells. If this happens, the cornea is covered by a different epithelium following an invasion of cells from the conjunctiva. This process leads to neovascularization, chronic inflammation and stromal scarring, rendering the cornea opaque and results in subsequent loss of vision. Conventional corneal transplants are an ineffective treatment in such cases.

Fig 1 Damaged eye before treatment

The therapy is based on cultures of limbal cells taken from the patient, which, once they have successfully grafted, regenerate the corneal epithelium and restore its functions. Limbal cell cultures even allow the possibility of treating patients with a loss of corneal epithelium in both eyes, provided that a small portion of limbus remains in one of the eyes.

Holoclar, is an autologous culture of limbal stem cells. It is made from a biopsy taken from a small undamaged area (minimum of 1-2 mm2) of the patient's cornea and grown in the laboratory using cell culture, and transplanted in the affected eye or eyes after removal of the damaged area. Such cultures engraft and permanently regenerate a functional corneal epithelium allowing recovery of visual acuity. replacing damaged limbal stem cells.

Fig 2 A cultured sheet of corneal epithelium

Holoclar can offer an alternative to corneal transplantation for replacing altered corneal epithelium in some cases, and it has been shown to increase the chances of a successful corneal transplant where the injury has caused extensive eye damage. It reduces the risk of rejection compared with transplanting tissue from a donor and does not require surgery on the patient's other eye as only a small biopsy is performed to collect the cells, thus reducing the risk of damage to the healthy eye. Therefore, Holoclar may also be suitable where both eyes are affected by moderate to severe LSCD.

Limbal stem cell deficiency is estimated to affect about 3.3 per 100,000 people in the EU, causing pain, photophobia, inflammation, corneal neovascularization, loss of corneal transparency, and eventually blindness.

The recommendation was made by the Committee for Medicinal Products for Human Use (CHMP) based on a robust assessment carried out by the Committee for Advanced Therapies (CAT), the Agency's expert committee for ATMPs.

“This recommendation represents a major step forward in delivering new and innovative medicines to patients,” says Enrica Alteri, Head of EMA's Human Medicines Evaluation Division. “EMA has used all available support tools to facilitate the development and assessment of Holoclar. It is an advanced therapy medicinal product that has been designated as an orphan medicine. This allowed the Agency to provide support including several rounds of free scientific advice to the applicant during Holoclar's development.”

The Committee for Advanced Therapies and the CHMP panels determined that although the product's benefits outweigh its risks, the marketing authorization should be conditional because the data thus far are retrospective and not yet comprehensive. Therefore, the EMA says, "an additional study on the use of Holoclar should be conducted."

The opinion adopted by the CHMP at its December 2014 meeting is an intermediary step on Holoclar's path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization. After that, decisions about price and reimbursement will take place at the level of each member state,  taking into account the potential role/use of this medicine in the context of the national health system of that country.

Update: On February 20, 2015, the EMA approved European marketing for Holoclar. Chiesi said that Holclar would be available to all suitable patients in Europe "in the near future".

References:

1. First stem-cell therapy recommended for approval in EU, European Medicines Agency Press Release, December 19, 2014

2. First-Ever Stem Cell Therapy Recommended in EU, Miriam E. Tucker, Medscape, December 19, 2014

3. Chiesi website

4. Holostem website

5. Europe approves Western world's first stem-cell therapy for rare eye condition, Reuters Press Release, February 20, 2015

To Acquire Skills In Taekwondo Portland Deserves The First Visit

By Jocelyn Davidson

Taekwondo as a martial art is made up of several combat styles that can be used for self defense or assault on an opponent. As a result of fast spreading, the art is now being taught in various places worldwide. According to history and belief, Taekwondo originated from China and Japanese with several other variations being practiced in other states. In order to learn professional taekwondo Portland offers a sure destination to visit.

The facilities in which this martial art is taught are referred to as schools. Students of varying skills and ranks are accommodated in the schools. Teachers and coaches have advanced training and experience which they use to train students. A facility may have more than one tutor with each handling different training sessions. Training and conditioning is done using a wide collection of equipment to achieve a high level of physical strength and flexibility.

The discipline uses different combat skills and styles allowing it to be used as both a defensive and a striking art. Practitioners are allowed to kick, punch, and hold their opponents during a tackle. Punches can be delivered using open hands, knees, and elbows among other parts of the body. Variations of the discipline also allow use of restraints, locks, grappling, holds, and vital point strikes.

Since the art equips students with deadly skills, the use of skills is highly prohibited unless it is in the defense of family, friends, or oneself against bullies. Careless use of skills can cause a lot of injury to an opponent especially those who are not trained in martial arts. Taekwondo is a powerful art and when the strikes are landed effectively on an opponent, they can cause death or critical injury. Coaches are supposed to warn their students during a class before beginning training.

An misunderstanding of what is entailed taekwondo continues to elude many people. Most people consider it as a rough and violent activity, which is very wrong. One has many other reasons for taking classes apart from gaining combat skills. For example, one can maintain a healthy lifestyle and a great and fit body through training. Training involves exercises that strengthen bones and muscles. Muscles are also tightened to give a great body.

One can also enhance their physical appearance by engaging in the discipline. The exercises also help in shedding off excess weight and unwanted mass in the whole body. Students can lose several pounds of weight within a short period of practice. Like other sports, this discipline is also good for relieving stress from the body. This is helpful in avoiding stress related medical conditions such as diabetes, heart diseases, and ulcers among others.

Hobbyists also find the discipline to be a great way of passing their free time. Enthusiasts of the sport like watching it and when they are free, they take part in classes or teach students for those with advanced skills. Infact, most training facilities are started by enthusiasts who then hire coaches and managers to run daily activities.

Competitive Taekwondo commands a large audience with fans worldwide. Students participate in international games like Olympics and others. Taking part in games may entail combat against an opponent or simple display of skills to viewers. Practitioners also attain ranks as they continue training and mastering skills.

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First Ever Yoga for Healthy Aging Residental Retreat Teacher Training!

We are excited to share the news that the next Yoga for Healthy Aging Intensive, to be held on June 23rd-30th, 2017 and co-taught by Baxter Bell and Melina Meza, will be our first residential retreat. It will be held in Scotts Valley, California, at the new 1440 Multiversity. We believe this residential retreat in the beautiful Santa Cruz Mountains, where you will stay onsite, have meals provided, and can enjoy the peaceful and lovely campus in the redwood forest, will be the perfect place to enhance your learning of Yoga for Healthy Aging concepts and practices. Please direct all questions about that are not addressed on the 1440 Multiversity website directly to Baxter at baxterbell@mac.com. 

The course will provide instructions on maintaining your physical, mental, and emotional health as you age. The main focus of the course is on preventative strategies, covering:

• Strength
• Flexibility
• Agility
• Balance
• Stress Management
• Circulatory System and Heart Health
• Brain Health
• Medical Conditions (in general)
• Equanimity
  

Melina and Baxter will present the scientific background that explains how and why yoga works to foster healthy aging, so you’ll understand which techniques to use when. They will also teach you the essential yoga poses, yoga sequences, and other practices that will set you up for a lifetime of practice. 

This intensive is designed for relatively healthy, relatively physically able participants. Not included in workshop: 1) Instructions for seniors who cannot stand unaided and need to practice in chairs and 2) Information about yoga as therapy for specific medical conditions.

For certified yoga teachers, this course will provide supplemental, specialized training in yoga for healthy aging techniques, which you can then teach to your own students. For yoga students with one or more years of experience, this course will provide you with the tools to create a personalized yoga program that meets your particular needs and concerns. 

For teachers who want YHFA Certification, you will need to:

1. Attend all the sessions during the intensive.
2. Attend the extra session at the end of the intensive, where you’ll do a short teaching demonstration.
3. Pass the take-home final that Baxter provides.
4. Provide a copy of your basic yoga teacher certificate (minimum 200hr training required) (or resume reflecting equivalent experience)

PRICING: 

Training: $760
Training + Certification: $910 

Additional cost of lodging and meals as specified at 1440 Multiversity. 

Baxter Bell, MD, eRYT500 is a co-founder of and regular contributor to the Yoga for Healthy Aging blog, where he shares his knowledge of medical conditions, anatomy, and yoga with practitioners and teachers across the world. In addition to teaching classes, workshops, teacher trainings, and retreats internationally, Baxter is a presenter at Yoga Journal Conferences and the International Association of Yoga Therapy’s Sytar Conference, and teaches online courses at YogaUOnline. 

Melina Meza, eRYT500, BS Nutrition, is a certified YFHA teacher and Ayurvedic health educator, who has been sharing her knowledge of yoga for over 20 years . Since 1997, Melina has been teaching at 8 Limbs Yoga Center in Seattle, where she is co-director of their teacher training program. Meza is the author of the Art of Sequencing books and contributing photographer for YFHA Blog. Currently residing in Oakland California, Melina facilitates year-round yoga workshops and retreats.

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My First European Trip The Interesting Adventures of A Consultant

Irv Arons

Recall that I had toured Europe in the fall of 1979, visiting the various contact lens companies that were based there, as well as interviewing notable doctors involved in their use, on an assignment to assess the contact lens companies in both the U.S. and Europe for a Japanese client interested in acquiring technology for starting a contact lens business in Japan.

This was my first trip to Europe and I kept a diary of my daily travels – the first and only time I have ever done so. It’s a good thing I did, because there were several interesting incidents that occurred that you might enjoy.

I flew from Boston to JFK, to pick up my flight to London. I arrived in London at 10 PM, and quickly realized a had made a big mistake. I had a fairly large piece of luggage (I would be gone for over a week.), and hadn’t taken my wheels! (This was the fall of 1979, before wheeled luggage was in general use.) I made it onto the subway and got into London from Heathrow and finally found my hotel, the Bristol. Except they didn’t have my reservation! Luckily they had one room left and I took it and went to sleep without supper, as the kitchen wasn’t open at that time of night.

The next morning, I met my ADL colleague from our London office, who would be my traveling companion (and translator). It turned out, the London office had made my hotel reservations at another hotel, and forgot to notify me. (Again, these were the days before email.) We then went on to the several meetings that we had arranged in the London area. I went to the final one that evening by myself – no problem – they speak Bloody English!

That evening my colleague had arranged for us to meet at a nearby pub for a dinner show. I was quite surprised to find that he and his girlfriend had brought along another girl, his girlfriend’s roommate, whose boyfriend was out of town. After the dinner and show, I got dropped off at my hotel (alone) because we had a busy next day – four interviews and then flying off to Paris.

After our interview in Paris, the next day, we flew on to Strasbourg and our drive to Freiberg for a contact lens conference. We drove through very beautiful farm land and took a local inland route to the Rhine river and across into Germany at a local crossing. The border guards stopped us, took our passports, and searched our luggage thoroughly. They were puzzled by my voltage converter (European to 110v for my electric shaver), but after about ten minutes, finally allowed us to proceed into Germany and we went on to Freiberg and the CL conference.

I spent the weekend on my own, as my colleague took the train to Frankfort to spend some time with friends, after buying me a ticket for my Sunday train ride. Since I speak no German (although understand a little based on my Jewish background), I somehow managed to survive the weekend since I knew the word for chicken (hundchen!).

When I got to the train station on Sunday morning, I couldn’t figure out which track the Frankfort train was on, but luckily, some English gentlemen saw my dilemma and helped me out. It turned out that they were the world famous Amadeus Quartet and also going to Frankfurt. I thoroughly enjoyed my train ride talking to them.

Arriving at the Frankfurt station, I met my ADL colleague and we took the train to our next stop, Aschaffenburg. We arrived early in the evening, and after dinner, went to a movie and I saw Moonraker in German and didn’t understand a word of it!

Following our nearly all day meeting in Aschaffenburg, we took a taxi to the Frankfurt airport for our flight back to London. After leaving my luggage to walk to the gate, I thought I heard my name over the loudspeaker, but since the announcement was in German, I wasn’t sure. Sure enough, when we arrived in London, I quickly discovered that my bag was still in Frankfort.

I didn’t panic too much, but since we were going out of London the following day for two days of meetings, I decided all I needed was a clean shirt and some deodorant to get me through until my bag showed up in London. I quickly went out to try and find a shirt and the only store open had a dress shirt that set me back 27 pounds (or about $50). Finally, about 8 PM that night I got a call that my luggage had made its way to London and would be delivered to my hotel room. You can be sure I got up early the next morning, before our trip out of town and returned that $50 shirt! (I kept the deodorant.)

After a few meetings in London, we took the train to Birmingham, had a couple of meetings there and on to Loughborough.

After several meetings, it was on to Hitchins and then Hempel Hempstead. (Yes, I did get to see quite a bit of England on that trip.)

The next day was my last in England and after several more meetings, I made my way via the subway to the airport and finally got on my flight back to the States.

After what I saw of the beauty of Europe, I made a promise that someday I would return. (And, my wife and I did. A few years later we took a sixteen day tour of eight countries - “If it was Tuesday, it must be Belgium!” As it turned out, we did travel through Belgium on our way from Paris to Amsterdam on a Tuesday.)

We have since gone back to Europe several times, particularly to Switzerland and to Spain, and even took a river boat trip down the great rivers of Europe, from Amsterdam to Vienna, passing through sixty-six locks along the way.