Project description
Innovative bioengineered skin grafts for transplantation
Standard of care split-thickness skin autografting procedure for the treatment of skin wounds often leaves patients with scars. After transplantation, the lack of dermis in the transplant induces a quick body reaction to create scar tissue and activate contraction to reduce the wound area. Contraction is characterised by skin constriction that results in additional scarring and functional limitations. The Swiss company CUTISS invented and developed personalised, bioengineered human skin graft technology to produce large quantities originating from a stamp-sized skin biopsy of the patient. The dermo-epidermal structure of the novel autografts will result in minimal scarring after transplantation. The EU-funded denovoSkin project aims to finalise a development plan in regards to the clinical validation of the product and its industrialisation.
Objective
Every year in the world, more than 50M patients suffer from skin defects (e.g. burns, excision, etc.) and need surgical intervention to restore skin function. Standard of care, skin autografting, very often leaves these patients with scars. Scars are permanent and disfiguring, and can also be painful and highly debilitating. Indeed, they may also impair movement and growth, and require several follow-up surgeries, intense homecare and psychosocial rehabilitation. Hence, scars significantly affect patient’s quality of life, along with the economic burden for the health-care system. Furthermore, in the case of large wounds, donor site shortage represents a real clinical issue. denovoSkin™ is a patented, personalized, bio-engineered human skin graft classified as Advanced Therapy Medical Product (ATMP). It is engineered in large quantities starting-off from a stamp-sized skin biopsy of the patient, thus solving the donor site shortage issue. Moreover, because of its dermo-epidermal structure, denovoSkin is expected to minimally scar after transplantation. Its outstanding performance could considerably reduce or even avoids further corrective interventions, allowing for considerable savings in terms of costs. denovoSkin™ is granted with Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA. So far, more than €14M have been invested over the last 16 years of research into the development and the clinical testing of denovoSkin™. To have denovoSkin™ fully projected at a European and global level we need a further investment of €3.57M to set up a solid EU value chain able to meet the large demand expected during the commercialisation via developing the automation of manufacture. The proposed work in Phase 1 of the SME instrument fits into our overall plan to reach the market by contributing the financial resources needed to plan a fast sound wider deployment of denovoSkin™ and its market uptake.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
- medical and health sciencesmedical biotechnologytissue engineering
- medical and health sciencesclinical medicinesurgerysurgical procedures
- medical and health sciencesclinical medicinetransplantation
- medical and health sciencesmedical biotechnologyimplants
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Programme(s)
- H2020-EU.2.1.2. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies Main Programme
- H2020-EU.2.1.5. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced manufacturing and processing
- H2020-EU.2.1.3. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials
- H2020-EU.2.3.1. - Mainstreaming SME support, especially through a dedicated instrument
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
8006 Zurich
Switzerland
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.