Tag Archives: burns

British company grows living skin

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London: A British company claims it has grown the “first artificial living skin graft”.

The firm, Intercytex, says the development is a ‘clinical breakthrough in regenerative medicine’ following early-stage trial results, which were published yesterday.

The technology, known as ICX-SKN could offer new hope for burns and wound victims and could be one of the first cell-based therapies to be approved under a new European regulation.

Currently the only solution for serious burns is to take skin grafts taken from the patient’s own body, however, it is a painful and traumatic process that creates an additional wound.Various synthetic forms of skin have been developed, with variable success in long-term healing.

ICX-SKN is made up of human dermal fibroblasts (a skin cell precursor) in a matrix of collagen, produced by the cells themselves.

To create the matrix, Intercytex takes a product made by Baxter called Tisseel, which is a combination of fibrinogen and thrombin (extracted from human blood) and mixes it with living human fibroblasts taken from neonatal skin – discarded foreskins in fact.

This liquid formulation is then poured into a dish, where the thrombin reacts with the fibrinogen to make fibrin, and after 15 minutes forms a gel.

This gel is then left to incubate for six weeks and the living fibroblasts that are trapped within the gel slowly break down the fibrin. At the same time they systhesise the collagenous matrix.

“It is a physical structure, but it is changing slowly,” Dr Paul Kemp, Intercytex’ founder and chief scientific officer told BioPharma-Reporter.com.

At the end of the incubation period, the resulting matrix sheet (which is about 1mm thick) is removed from the dish, packaged and stored ready for use.

Intercytex’ scientists said they believe that the combination of living human fibroblasts in a human fibroblast-produced matrix “underpins the integration and acceptance of ICX-SKN by the host skin.”

In the Phase I trial, conducted in London by a third party organisation, a full-thickness skin sample (1.5cm x 1cm) was excised from the upper arm of six volunteers and replaced with ICX-SKN. After 28 days both visual and histological analysis showed that in all volunteers the grafts were rapidly vascularised and overgrown with the hosts’ own cells, resulting in a fully integrated skin graft that had closed and healed the wound site, the firm said.

Results of the trial were published yesterday in the July issue of Regenerative Medicine.

Phase II efficacy trials in larger wounds with a view to generating data that would enable progress to pivotal trials are now planned for the end of the year. The results of these tests will obviously give a better indication as to whether this new therapy is actually better than other synthetic products on the market, because it is more difficult to heal real burns and wounds in patients than it is to heal small, surgically-created wound in healthy volunteers.

Kemp said he was unsure whether they will be carried out in Europe or the US – the company is looking to eventually commercialise the product in both markets. The picture is hazy on the issue of its regulatory pathway though.

At the moment, the product is being treated in Europe as a regular medicine, although the European Medicines Agency (EMEA) is due to release a new guideline covering the regulation of cell- or gene-based therapies (advanced therapeutic medicinal products: ATMP) by the end of the year. After this point, the product will follow the new regulatory pathway.

“We don’t know yet exactly what this new regulation will involve, however, I think it will be pretty similar to the process for regular medicines with a few slight changes,” said Kemp.

This is because cell- or gene-based therapies have specific nuances, such as they can’t be terminally sterilised because they contain living cells, he said.

In the US, Kemp said he was unsure whether it would be classed as a biologic or a device because the firm has not yet asked the Food and Drug Administration (FDA) and there is no pathway that deals specifically with cell- or gene-based therapies.

The market for such products is fairly new, and although it has so far been limited by an inability to create tissues in the laboratory that are recognised as natural and can be fully integrated into the body, it is beginning to show promise.

A recent US Department of Health and Social Services (DHSS) report states that the worldwide market for regenerative medicine is conservatively estimated to be $500bn (€371bn) by 2010.

Ulcer and burns warning over DIY teeth whitening kits

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London: A leading cosmetic dentistry body today warned that some DIY whitening kits may cause chemical burns and ulcers.

As a result the British Academy of Cosmetic Dentistry (BACD), the professional body that represents UK cosmetic dentistry practitioners has issued its Whitening Safety Guidelines, to ensure patient protection and satisfaction. Earlier this year, the BACD published a survey that revealed over a quarter of Britons have had cosmetic dentistry treatments, whitening being the most popular.

Leading dentist and BACD Board member James Goolnik says: “Time, smoking, tea and coffee are just a few of the things that cause your teeth to yellow and discolour. Whitening is a bit like a facial in that it helps to unlock pores in your tooth so that stains are gently removed leaving teeth cleaner and brighter. Whiter teeth can take years off your appearance, and the effects, depending on your lifestyle, can last up to ten years. But just like people’s mouths, all whitening techniques are not created equal.”

The length of time whitening can last will depend on whether or not the person smokes or how much tea, coffee and red wine they drink. Although the teeth themselves will whiten, any fillings or crowns will remain the same colour and may need replacing to match the new lighter colour of the rest of the teeth.

Dr Goolnik comments: “All whitening is based on a hydrogen peroxide solution; the only difference in the hundreds of systems out there is the concentration and the way the solution is applied to your teeth. Not all of them are safe and it is essential people consult their dentist, as some whitening kits bought over the counter or abroad can cause permanent damage.”

Dr. Goolnik recently saw a patient, Tamara Morris, 27, who suffered painful mouth ulcers resulting from a whitening kit bought at a high street pharmacy.

Tamara, who works in a beauty salon said: “Although it burned my mouth slightly when first I used the gel, I thought this was normal. Afterwards, it hurt when I brushed my teeth, or when I drank anything hot. When I went to the dentist he discovered I had sores on my gums resulting from the treatment.”

According to the BACD, there are two main ways of ‘properly’ carrying out tooth whitening:

1. Tray based. The gel is placed in a custom made night-guard which is worn from one hour to overnight for 7-10 nights depending on the gel, provided by your dentist.

2. Surgery based – otherwise known as laser or power bleaching. Here, more concentrated gels are applied directly to your teeth and accelerated with heat or light (laser/power). Usually a one-hour appointment is needed with maintenance provided with top-up trays.

TOP TIPS

No whitening is permanent. Maintenance is needed to keep that bright smile.
Only a dentist can get your teeth to the maximum whiteness.
See a dentist first to check teeth are healthy before starting. Teeth and gums can become permanently sensitive if they are not healthy first.
There is no evidence that whitening toothpastes can actually whiten your teeth.
Whitening kits can at best do nothing and at worse some of those bought abroad or over the internet can actually harm your teeth as they contain acids/abrasives that can cause permanent damage.

About the BACD – www.bacd.com

The British Academy of Cosmetic Dentistry is a not-for-profit, inclusive organisation for the advancement and ethical delivery of cosmetic dentistry, open to all dental professionals including dental technicians and hygienists. Their aim is to create a dynamic, active group of members from all areas of the dental team. The BACD, which has over 400 members, is affiliated with the American Academy of Cosmetic Dentistry, the world’s largest organisation for cosmetic dental professionals.

Injectable fillers and implants

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All of these treatments are best used for deeper lines such as deep mouth to nose and around the lips. Aimed at individuals who would prefer to avoid surgery, such as a facelift.

Autologous fat

Fat is taken from the stomach, thights or bottom and after being processed is can be injected into lips, hands, nose to mouth lines, cheeks or acne scars. The results last up to two years.

Arteplast (Artecol)

A combination of collagen and polymermethyl-methacrylate used on superficial facial lines such as the forehead.

Collagen

A connective substance found naturally in the skin and which helps it maintain elasticity. As you get older it diminishes giving way to to lines, particularly around the mouth and eyes. In these procedures the collagen is created from bovine sources, steralised and suspended in saline. It is injected, using a fine needle, into the required areas that need plumping out. The effect lasts for several months and treatments can be repeated time and time again. Anyone considering this would need to have an allergy
test beforehand. About $400 to $500 for each area.

Polymethylmethacrylate

One of the new permanent injectable skin fillers that is awaiting FDA approval is polymethylmethacrylate, made from a mixture of micronized plastic spheres and bovine collagen. When polymethylmethacrylate is injected into the skin, the collagen works by holding the synthetic spheres in place until it dissipates after injection — leaving the spheres behind to prop up the wrinkles. These spheres stimulate the body’s own production of collagen, which then forms around the spheres.

One side effect of polymethylmethacrylate include permanent or long-term lumps and temporary swelling and redness, especially when used in the lips.

Hydroxyapatite with a Methylcellulose Vehicle

For patients looking for longer-lasting results than collagen but not the permanent results of polymethylmethacrylate, a new filler known as hydroxyapatite with a methylcellulose vehicle — which is currently FDA approved for other purposes — is being studied as an injectable skin filler. The synthetic compounds used in this filler contain beads of calcium hydroxyapatite, which is a substance used to replace missing bones.

Hydroxyapatite with a methylcellulose vehicle provides a temporary correction of wrinkles that lasts about one year, but the exact duration of this filler has not been demonstrated yet. If not injected properly, the calcium beads could clump together and result in lumpiness in the treated area.

Poly-L Lactic Acid

Poly-L lactic acid is not really considered a skin filler, but a “dermal stimulator” because it stimulates the skin cells to make collagen — providing a slow correction over time. Patients are treated every month for four to five months until the correct results are achieved, results typically last one to two years.

Research studies of poly-L lactic acid for FDA approval of wrinkles are just beginning and it could be a new option for patients looking for a safe, long-lasting fix for wrinkles.

Before considering any skin filler treatment, it is recommended that patients ask the following questions:

1. Are the results permanent or temporary?
2. What are the potential side effects?
3. Is the filler approved by the FDA for this use?
4. How long has the physician used the filler? How many patients has
the physician treated? Are before and after photos available?

Isolagen

Cells are taken from behind the patient’s ear, where there is less sun damage, and cultured in a laboratory and then injected back six to eight weeks later into the face. Isolagen was launched in the UK in 2003 and although the results are not immediate it appears that top up injections are not needed as the results last.It has also proved successful in treating acne, scars and burns. It may also be used to help receding gums. It has yet to get the go-ahead of the FDA in the US. www.isolagen.com

Hyaluronic Acid Fillers

Recently approved by the FDA as a skin filler, hyaluronic acid is a naturally-occurring component of the skin that functions by holding together collagen and elastin, providing a framework for the skin. When injected into the skin in gel form, hyaluronic acid binds to water and provides volume to easily fill in larger folds of skin around the mouth and cheeks. Patients notice an immediate plumping of the skin in the treated areas.

One of the main advantages of hyaluronic acid gel is that it does not pose an allergy risk for patients and there is no risk of transmitting animal diseases by injection. Since a skin check for allergies is not required with hyaluronic acid gel, patients can be treated on their first visit to the dermatologist. The results of hyaluronic acid last approximately four to six months and require less volume to fill wrinkles and hard-to-treat skin folds compared to collagen. The main brands are Restylane and Perlane which is a stronger version.

These are used to fill out lines as a result of ageing where the skin has lost its elasticity. The target areas include eyes lines, mouth lines, smile lines and frowns between the eyebrows. Treatment takes 10-20 minutes and results last for up to nine months before a top up treatment is necessary. There may be some redness and swelling after treatment but this normally goes in a couple of days.

Newfill

Newfill is a way of resculpting the face without surgery, using an injection which consists of a saline gel with a product called Newfill, a naturally occuring polylactic acid which stimulates the body to produce its own collagen. Initially the gel fills the wrinkles and hollows, but soon disperses in the body and the patient’s own collagen is given a kick-start.

Patients usually have two sessions, at least 15 days apart, and the final result can be seen 20 days later. Results from most fillers, such as Restylane, last only three or four months, But the improvement from Newfill typically lasts for a year or longer.Th amazing thing is that Newfill has been used in surgery for the last20 years, and as a polylactic acid is found naturally in the body, and as a a result allergic reactions are rare.Unlike collagen it is not derived from animals.It can be used to treat lines on the neck as well as to rejuvenate hands, knees and ankles.

Permanent/Semi Permanent Fillers

Silicone

Banned in the US because of the risks of infection and scarring but it is still used in the UK, although increasingly less so. The liquid is injected straight into wrinkles, is permanent but there is a greater risk of hard lumps.

Gortex

This is a man-made breathable membrane, is used as a permenant wrinkle-filler and comes in several differnt forms such as, sheets, strips and tubes. Since it is porous the skingrows into it. Used to correct wide scars and deep wrinkles.

Alloderm

Made in the US from a natural deep-layer skin collected from corpses, purified and freeze-dried. Prior to use it is reconstituted using saline and implanted in sheets or strips,acting as a frame for the patient’s skin. Overtime it may be partially reabsorbed but there is little risk of rejection. A similar treatment using pig tissue is also being developed.

There is always a risk of rejection with foreign materials. The injected collagen eventually breaks down and fades away. Top-up treatments will be needed every few months, dependingon the individual. Some people develop an allergy – a test is made prior to the treatment, and a furtherone percent may show a reaction is excessive redness and swelling after treatment.
Three months and silicon and Gortex are permenant. Alloderm is semi-permanent. Recovery is immediate with perhaps some redness and swelling which will go down after a few days.Discomfort is minimal as the procedures are carried out with local anaesthetic.A hospital stay nnecesssary as it can be done in a lunch hour and is available at various clinics.
The Collagen Information Service Freefone is run by Collagen (UK) 0800 888 000.