Skin is a human´s largest organ. Human skin is frequently damaged resulting in the loss of its integrity and physiological balance, which may result in significant disability and infections. The skin’s natural restorative capacity is sufficient to heal itself when injured superficially (epidermis). Yet human skin cannot heal itself without medical intervention when wounds are too deep and damage the dermis. Deep partial (partial living dermis left) and full-thickness skin (no living dermis left) wounds are still a significant challenge to clinicians. Standard of care for the treatment of deep partial and full thickness skin wounds is split-thickness skin autografting. Split-thickness skin grafts (STSG) are thin but transplanted on deep wounds, thus the body creates scar tissue to fill up the gap and induces contraction to try and reduce the wound volume.
Unfortunately, too often, standard of care leaves patients with scars. STSG is composed of the epidermis but only remnants of the dermis. After transplantation, this lack of dermis induces the human body to react by quickly creating scar tissue (to fill up the gap), and by activating contraction (to reduce the wound area). Contraction leads to deformity and is characterized by skin constriction that results in scarring and functional limitation.
Furthermore, donor shortage is the biggest limitation in skin substitutes nowadays in the treatment of large skin wounds that require surgical intervention. To try to overcome donor site shortage, STSG can be meshed, but only up to 9x its size. Also, it can be repeatedly taken from the same site, but with long waiting intervals in between the harvestings, high distress for the patient and the unsatisfying final outcome that also results in scarring on the donor site area.
Being the outermost organ, skin health also entails social and behavioural impacts on individuals. Patients with conditions such as scarring frequently face psychologic challenges which, in turn, impact their social functioning and the kind of life that they lead. Patients may experience fearful anticipation of interaction with others, and develop avoidance-coping mechanisms. This may prevent them from partaking partially, or fully, in social and recreational activities or employment. Ultimately, visible symptoms may change how patients see themselves and how they perceive their future.
While the culturing of autologous epidermal sheets has been achieved, the real clinical challenge is creating a personalized, safe graft with a dermo-epidermal biological structure, in a relatively short time that minimally scars after transplantation that growth with the patient. denovoSkin™, possesses all the right features to target these medical needs. It is dermo-epidermal, meaning that the resulting graft is composed of both the dermal and epidermal layers, therefore the body will have little means of inducing contraction and scar tissue formation after transplantation. To produce denovoSkin™ a very small (at least 2cm2) skin biopsy is needed to produce high amounts of skin grafts and its single harvest causes minimal distress to the patient. It can also be produced in a relatively short-time and reduces or even avoids the need for further corrective interventions being a more cost-effective solution.
Throughout the Feasibility Study, CUTISS reviewed its progress to date and defined a sound development plan based on the remaining activities to be executed for denovoSkin™´s development. denovoSkin™ is at a mature stage of development and the steps planned regard the clinical validation of the product and its industrialization. The key objectives of denovoSkin™´s development are now to get the Orphan and Reconstructive Market Authorisation and to automate its production process to be at the forefront of the European Tissue Engineering Market.
