|The press release from June 26th 2007 is as follows:
The laboratory-manufactured human skin ICX-SKN
demonstrates full, consistent wound integration and persistence represents important landmark in regenerative medicine.
It contrasts with all other living skin graft alternatives which biodegrade in situ after a matter of weeks.
In the trial (which is published today in the July issue of Regenerative Medicine, available now for online viewing at www.futuremedicine.com), a full-thickness skin sample was excised from the upper arm of six volunteers and replaced with Intercytex` skin graft replacement product, ICX-SKN.
After 28 days both visual and histological analysis showed that in all volunteers the ICX-SKN 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.
ICX-SKN comprises a collagen-based matrix produced by the same skin cells - human fibroblasts - that are responsible for laying down the collagen in natural skin.
The fibroblasts weave a collagen structure which mimics that found in skin and which shares many of the structural attributes of skin. Intercytex` scientists 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.
To date, other living regenerative medicine skin constructs have degraded too quickly to act as skin grafts when implanted in the human body.
In certain wounds and burns the use of skin grafts taken from a different part of the patient`s own body is the optimal treatment to obtain wound closure.
However, their use is avoided wherever possible because skin grafting itself is a painful and traumatic process that creates an additional wound. ICXSKN represents a potential alternative which could be of enormous benefit to patients and physicians.
The next stage of clinical development will involve application of ICX-SKN to larger wounds with a view to generating data that would enable rapid progress to pivotal trials and granting of a marketing licence.
Dr Paul Kemp, Intercytex` Founder, Chief Scientific Officer and senior author of the paper, said:
`Intercytex intends to develop a range of cell-based implants that can regenerate lost tissue and this research is an important milestone in the pursuit of that objective. For regenerative medicine to fulfil its promise, scientists need to develop cellular implants that are accepted and integrated into the human body. So far this has proved elusive but today`s research shows, for the first time, that it can be achieved.`
Dr Stephen L Minger, Director, Stem Cell Biology Laboratory, Wolfson Centre for Age Related Diseases, King`s College London and an acknowledged world expert in regenerative medicine, commented: `I think these results are a real breakthrough in the field of wound healing and regenerative medicine in general. To have an off-the-shelf skin replacement product that can be used in large numbers of patients will revolutionise the treatment of burned and skin damaged patients.`
Mr Ken Dunn, Consultant burns and plastic surgeon at University Hospital of South Manchester, said: `Surgeons have long had a need for a skin graft replacement. The data described in this paper offer real promise to provide surgeons with a product that could be used `off-the-shelf`to help to heal patients.`
A recent U.S. DHSS report states that regenerative medicine is in `the vanguard of 21st century healthcare` with a `worldwide market for regenerative medicine conservatively estimated to be $500 billion by 2010`. However, the field has been limited by an inability to create tissues in the laboratory that are recognised as natural and can be fully integrated into the body.