Creating skin from hair – transplants heal chronic wounds
02.11.2004 Creating skin from hair – transplants heal chronic wounds
euroderm GmbH from Leipzig is to transfer production of its skin transplants to Stuttgart.
Managing Directors Sabine Krüger and Dr. Andreas Emmendörffer searched all over Germany for suitable clean rooms and manufacturing conditions and found them at the Stuttgart Fraunhofer Institute for Interfacial Engineering and Biotechnology (IGB).
It sounds like a vision of the future:a few hairs are taken from patients whose wounds are hard to heal and after 28 days a skin transplant is supplied that heals the wound quickly and easily.
This "wonder cure" has been made possible thanks to a technique for growing human skin from hair roots, a world first from euroderm GmbH."We create real skin, not just skin cells from a test tube," explains Andreas Emmendörffer, outlining the new technique."The cell culture provides prefabricated epidermis so the formation of the new epidermis no longer has to take place directly on the wound.
We provide a complete transplant that just has to be grafted on the wound."
Biotech company euroderm, founded two and a half years ago in Leipzig, specialises in two areas:the medication sector providing treatments for chronic wounds and providing human skin models for industry or research institutions that can be used for testing cosmetics, pharmaceuticals or chemicals as an alternative to animal testing.
The German Pharmaceuticals Act stipulates particular requirements for premises used to manufacture skin transplants for treating chronic wounds.
Only certain GMP (good manufacturing practice) laboratories, i.e. clean rooms, are authorised as production environments for tissue engineering products and work performed here must use certified processes.
In the STERN BioRegion, at the Stuttgart Fraunhofer IGB, euroderm found the perfect laboratory conditions:"This is a site with a great deal of expertise in regenerative medicine. As winner of the BioProfile competition, the STERN BioRegion received Euro 18 million in grants for projects from this very area."It also has a very impressive infrastructure and provides an active research environment."With its industrial vision, economic funding and logistics, this is the perfect site.
It’s ideal for supplying our key customers in Switzerland and soon in France and the UK too."
To grow its operations, above all sales, euroderm is looking for a suitable finance model."The required sum of maximum Euro three million is not particularly interesting to venture capitalists, not without another nought on the end.
That’s why we’re looking for private capital, e.g. from Business Angels."
Companies operating in the field of regenerative medicine need to have long-term staying power.
Outpatient treatment with the skin transplants costs around Euro 3,500, which, although funded by most private insurance companies, is hardly covered by any statutory health insurance funds.euroderm is currently working on making the procedure more attractive to self-funding patients.
As Andreas Emmendörffer explains: "This also allows patients, whose treatment costs are not covered by statutory health insurance and who have already had to live with their ailment for months or even years, the opportunity for quick, effective treatment.
Switzerland already has statutory reimbursement of costs for skin transplants.
There, health insurance funds are obliged to cover the costs, provided the treatment is prescribed by a doctor who has been trained in the technique."Both managing directors are hoping that Germany will follow suit in three years, at the latest.
A clinical, multicentric study with patients from Germany and Switzerland has been successfully completed and published.
The new technique has every chance of succeeding. The benefits are plain to see. Affected patients can donate a few hairs in their doctor’s practice, which then sends them to the laboratory.
A few weeks later the transplant that has been grown is applied to the wound in a normal treatment room and then treated on an outpatient basis.
One key conditionis that the wound must be free from bacterial infection, otherwise there is too great a risk of the transplant not taking.
However, there’s still some work to do in convincing people of the benefits of the new treatment:"We are in competition with surgeons in the hospitals and clinics who treat critical wounds by opening a further wound and grafting a piece of skin onto the problem area.
Our method is quicker and costs at least a third less – and of course it’s much less distressing for the patients."
If the economic expectations are met, euroderm may build its own clean-room complex in a few years.
However, euroderm is especially keen to avoid the errors made by other biotech companies that tried to grow too fast.
They are planning to proceed step-by-step:"At the moment, we are waiting for the manufacturing license to be validated and we are very optimistic that we will soon receive it. The infrastructure is already set up."