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Novel bio-engineered dermo-epidermal skin grafts: A report on phase I clinical data and new experimental findings
Spring Dermatology & Skin Care Expo Conference
May 14-15, 2018 | Montreal, Canada
Ernst Reichmann
Tissue Biology Research Unit, Switzerland
Scientific Tracks Abstracts : Dermatol Res Skin Care
Abstract:
The Tissue Biology Research Unit (TBRU) in Zurich has bio-engineered innovative autologous skin grafts for the treatment of skin defects and abnormalities such as burns, chronic wounds, wounds caused by tumor resection and infections. Our skin grafts can reach up to 70 times the size of the original biopsy in a relatively short time (min 12 days for a dermal graft, 20 days for a dermo-epidermal graft). After transplantation, the bio-engineered autologous skin grafts permanently remain on the patient and replace skin in its full thickness. Phase I clinical studies for one of our products (denovoSkin) are now completed. Results in terms of safety (and already efficacy) are very promising. Multicentric Phase II studies have started in late 2017 in six different clinical centers in Switzerland, the Netherlands and Great Britain. Orphan Drug Designation (ODD) for the treatment of burn injuries has been reached for denovoSkin in Europe (EMA), Switzerland (Swissmedic) and the USA (FDA). Our present research focuses on the development of even more complex skin grafts which will comprise pigmentation (to match the skin color of the patient), and the establishment of a dermal network of blood capillaries (to fasten take and regeneration after transplantation). A corresponding product is close to being used at the bed-side. Pre-clinical studies (including proof of concept and toxicological studies) have already been conducted. Establishment of the GMP production of this product is ongoing and within reach. First-in-man trials, on both adults and children, are foreseen for late 2018.
Biography:
Ernst Reichmann is currently in Tissue Biology Research Unit as a Group Head and Professor in Switzerland. He is the author of over 60 publications, in peer-reviewed journals. He is a reviewer for multiple journals with positions in others. His expertize includes an interest in the Tissue Biology of skin grafts including dermatological diseases.
Email: madaleneheng@aol.com
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