Intercytex Group plc, a Cambridge, UK company, is reporting positive results from a recently completed Phase I trial of its allogeneic skin graft replacement, called ICX-SKN. For the common peasant, allogeneic means from an unrelated donor.
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.