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Author Topic: New Filler On The Horizon??  (Read 2858 times)

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Offline MitchMiller

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  • Posts: 471
New Filler On The Horizon??
« on: May 10, 2007, 09:38:17 PM »
They also are testing a procedure for growing your hair follicles outside of the human body, then transplanting them back into your head (I'm not straight-on w/that explanation, but go to the co. site for more info)

http://www.intercytex.com/icx/products/aesthetic/icxrhy/

ICX-RHY is a novel facial rejuvenation product designed to enhance the skin’s collagen support matrix, thus enabling the appearance of facial wrinkles and folds to be improved. It aims to provide a more youthful appearance, helping to combat the cosmetic effects of ageing.

ICX-RHY comprises allogeneic, collagen-secreting human dermal fibroblasts (HDFs) presented in a sterile suspension. It is injected intradermally into the affected area using local anaesthesia. A straightforward and minimally invasive procedure - each injection will deliver a minute volume of ICX-RHY. The benefit is expected to become apparent once injected HDFs have begun to lay down new collagen within the dermis. This effect is expected to be sustained, providing long-term enhancement of the facial appearance. It is anticipated that repeat administrations will be given as required.

A Phase I trial, consisting of a placebo-controlled safety and tolerability study in ten healthy volunteers, has been completed. Each subject received a course of three injections given into the skin of the upper arm. ICX-RHY was shown to be very well tolerated; no serious adverse events were reported and all adverse events were transient and resolved without treatment.

A Phase II trial has commenced in the UK, designed to test the efficacy of ICX-RHY in naso-labial folds. A second Phase II trial is planned to commence during the second quarter of 2007 to evaluate the efficacy of ICX-RHY in facial imperfections caused by acne. It is anticipated that preliminary results from these studies will be available at the end of 2007.

In March 2006, Intercytex received confirmation from the MHRA (Medicines and Healthcare products Regulatory Agency) that ICX-RHY was outside the scope of the current legislation covering the marketing of medicines and devices in the UK. Intercytex plans to make ICX-RHY available in the UK market once additional clinical data are available, at the end of 2007, under the trade name VAVELTA™.

Once approved, it is envisaged that VAVELTA™ will be administered by cosmetic surgeons, dermatologists and other healthcare professionals specialising in aesthetic medicine.

Glossary

Downloadable product sheet

Offline MitchMiller

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  • Posts: 471
Re: New Filler On The Horizon??
« Reply #1 on: May 10, 2007, 11:16:08 PM »
Another story on that product that explains a bit more about how it works...

IT IS being touted as the miracle cure for ageing. The treatment involves injecting cells grown from another human into the skin, encouraging it to regenerate.

These cells - called fibroblasts - are responsible for making collagen, a protein that gives skin its strength and elasticity.

They are abundant in young skin but their numbers reduce as we age, allowing lines and furrows to form.

Now scientists at Cambridge-based biotechnology firm Intercytex have discovered a way to grow them in the lab.

When injected into wrinkles, they should lead to the gradual production of collagen smoothing away the ravages of time.

Intercytex's Nick Higgins said: "What people really want is to have the skin they had when they were younger, which was plumper and thicker.

"Boosting the number of fibroblasts has the effect of increasing the amount of collagen, so we go from a thin skin to a thicker skin, and as skin thickens, wrinkles disappear."

The treatment is soon to be tested on the wrinkles that stretch from the edges of the nose to the edges of the lips and on acne scars.

Currently known only by its laboratory name ICX-RHY, it will be available in surgeries from the autumn. A course of treatment will cost up to £5,000, making it cheaper than a facelift which costs up to £10,000.

It is hoped the treatment will last up to three years, making it longerlasting than Botox, which has to be redone every four months or so and costs between £200 and £300 a time.

Crucially, the gradual rejuvenation would appeal to those who want to avoid the questions arising from a sudden change in their appearance.

Patients will be given a series of superficial injections of fibroblasts over a 20 to 30 minute period and under local anaesthetic.

Each injection-which will contain millions of cells, will penetrate no more than 1mm under the skin, with patients needing only one injection per square centimetre of wrinkle.

This means that a patient might need 12 injections to iron out a forehead furrow or four to fill the wrinkle that stretches from nose to lips.

The procedure is repeated six weeks later, and the skin rejuvenates over three to six months.

The cells - all of which have been generated using a sample from a single donor in the U.S. - have been screened for infection and should not cause an allergic reaction.

Mr Higgins said: "Ultimately, we could see this being used preventively. You could imagine people maintaining a youthful experience by keeping their fibroblast numbers up."

 


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