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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

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Yeastrol Is A Complete Treatment For The Cure Of The It Permanently

By Ronica Bean

It is better than any of the other OTC it solution available in the market. Yeastrol helps in treating the most severe forms of its.

When this is not treated quickly it can cause many other problems and medications from the doctor do not always treat these symptoms. With Yeastrol, you are going to attack everything.

Yeastrol gives complete treatment and eliminates it completely. There is a difference between the OTC treatment and the Yeastrol treatment. Treatment done by OTC products cures the problem and as you stop the treatment, the problem recuperates but with a Yeastrol product, the cure is permanent and the problem does not arise again and the cure is done forever.

This product does not have any side effects and is completely safe and non toxic. Yeastrol is a homeopathic treatment and is a side effect free treatment. During this treatment with Yeastrol, you will never feel drowsy or nausea. This product is made by a combination of highly effective ingredients that make this product give a 100% result.

Yeastrol

In OTC it treatment, products used are made of mediocre ingredients, so you also find that the results of the treatment are also mediocre. On the contrary, Yeastrol gives you a complete and safe treatment that cures you of the it permanently because of the homeopathic natural ingredients used in the making of Yeastrol.

Yeastrol comprises of twelve ingredients. They are Candida Albicans, Baptista Tinctoria, Borax, Echinacea Augustifolia, Nitricum acidum, Sulphuricum acidum, Kresotum, Thuja Occidentalis, Pyrogenium, Mercurius sulphuratus ruber, Mercurius cyanatis and Candida parapsilosis.

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Yeastrol is both a highly effective way of treating any it and also it is a very safe way of treating the it. It does not make any drug interactions and so it helps in treating from these infections in a very safe manner. All forms of its are accompanied with some or the other related symptoms. Yeastrol has a special quality inn treating these related symptoms also along with the main problem. It has no side effects. It is the safest form of treatment.

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Getting rehabilitated with the use of movements can be hard. You are required to push yourself to the limits even when you think that you can never recover from your condition. However, it can provide you with some benefits too. So, simply get to know all of them ahead of time.

There shall be less stress in your system since there will be lesser time for you to think about your problems. Thus, simply allow movement based treatment to take away at least some of your burden. In trying to become happier, you are giving your body more reasons to fight this disease in the process.

You shall slowly get back your self esteem. Since you are seeing your own progress, one would stop feeling useless. So, simply stick with the routine which would not stress you out that much. Take baby steps and stop when you have already completed an hour of stretches. Listen to your therapist.

You can finally have an outlet for your emotions. If one is angry at the situation, put that anger in gaining more control of your lower limbs. Do not let frustration get the most out of you. Thus, try to develop a happier disposition in life too. This is only a set back which can launch you into something bigger.

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Just be open to the pain that would come before you attain your success. Hardships would be there too since you still need to get used to this routine. What is important is that you shall not give up on what you have started and be willing to take your exercise to a whole new level once you see some changes.

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By Ann Martin

Everyone has experienced acne at least once in their lifetime. Most patients have adopted various techniques in an effort to win the battle against such spots. Some have turned out to be excellent methods while some have been futile. Modern medicines are good for most patients. However, side effects are a nagging problem associated with such drugs. This excerpt sheds light on why you should consider natural acne scar treatment.

Aloe Vera is the most recommended natural form of medication. The plant is a great source vitamins which promotes healing of skin and fading of pimples. In addition, they induce moisture leaving the skin with a soft and healthy look. While the drug can be found in drug stores, it is advisable to procure the indigenous plant. Discourse involves applying small amounts of gel on spotted areas and massaging gently. The gel ought to soak for thirty minutes for best results.

Turmeric powder is a reputable ingredient with a high healing power. The powder possesses antibacterial properties essential in curing spots. The technique adopted involves mixing the powder with mint juice. This sludge ought to be applied on spotted areas and letting it soak for fifteen minutes. Afterwards, applied material can be washed off with normal water. Honey can be added to make it more effective.

Coconut oil is an effective cure that has been lauded by several skin care experts. Patients are instructed to scoop a teaspoon of coconut oil and letting it melt at room temperature. Massaging on spotted area takes place afterwards. However, it is not necessary to cleanse the face as the vitamins are known to improve skin texture. Clients should soak heavy oil for at least thirty minutes before washing can be done.

The use of cucumber juice and yogurt is encouraged by nutritionists from far and wide. This compound possesses shedding abilities which reduce spread of pimples and revive skin health. Cucumber is rich in vitamin C, A and B1 which lessen blemishes. Guidelines entail making cucumber juice and mixing it with yogurt. The paste should be doused for twenty minutes on damaged skin parts. The paste is washed off with normal water once stated time has elapsed.

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Rose hip seed oil is a unique skin moisturizer. It is advisable to use organic oil for maximum benefits. This non greasy liquid needs to be applied twice each day for impressive changes. Fatty acids and vitamin A are major catalysts for good skin.

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